Generics

Generics in Pakistan

This is the first of a series of three articles on the problems facing Pakistan in making health care affordable to ordinary people.

Gilead makes HIV generics deal

US-based drugmaker Gilead Sciences (Gilead) announced on 2 August 2012 a new collaboration with Indian generics manufacturers to provide low cost HIV medicine to developing countries.

Ranbaxy forfeits exclusivity on generic Provigil

As part of Ranbaxy’s consent decree with FDA, signed in January 2012, the Indian generics major had to agree to relinquish 180-day marketing exclusivity on three pending generic drug applications [1]. Now analysts believe that generic Provigil (modafinil) may have been one of those undisclosed drugs.

Canada grapples with drugs costs

Government report calls for the widening of the current scheme for brand-name medicines to include generics.

FDA approves generics of Merck’s Singulair

FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).

Pfizer wins against generic versions of pain drug Lyrica

The world’s largest drugmaker Pfizer has successfully blocked Israel-based Teva Pharmaceutical Industries (Teva) and other manufacturers from selling generic versions of its fibromyalgia treatment Lyrica (pregabalin) until patents on the drug expire in 2018. The ruling, announced on 19 July 2012, was the result of a lawsuit begun in 2009 contending that sales of generic Lyrica would infringe Pfizer’s patents and cause irreparable harm to sales.

Watson gains FDA approval for morning after pill

US generics company Watson Pharmaceuticals (Watson) announced on 13 July 2012 that its subsidiary Watson Laboratories, has received approval from FDA for its Abbreviated New Drug Application (ANDA) for Next Choice One Dose (levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women’s Health’s Plan B One-Step. Watson plans to launch the product immediately.

UK spending on brand-name drugs predicted to reduce

Spending by the UK’s National Health Service (NHS) is under control according to a new report, and in fact spending on brand-name medicines is expected to reduce in real terms and as a proportion of the UK healthcare budget over the next three years.

Generics have their feet under the table in Malaysia

Generics manufacturing, prescribing and sales are becoming firmly part of the scene in Malaysia.

Generics companies turn to ‘third tier’ countries

With pharmaceutical growth in the doldrums in the west, and China and India are becoming increasingly confident, attention is turning to countries such as Indonesia and Turkey.

Is the pharmaceutical industry on the verge of as big a change as we have seen?

‘The old order changeth, yielding place to new’ [1]

For many years the Trade Related Intellectual Property Rights (TRIPS) negotiations have been criticised as being overly protective of the rights of large pharmaceutical companies. ‘It is unacceptable to threaten developing countries aiming to provide medicines to their populations, and disregarding international commitments to ensure access to medicines,’ ran a Médecins sans Frontières statement in 2010. ‘The US is using its trade laws to bully developing countries into applying arbitrary pharmaceutical industry requests at the expense of millions of people who depend on generic medicines in developing countries.’

More downs than ups for Ranbaxy

A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the Maharashtra FDA (FDA, Maharashtra State, India). The Indian crack-down on Ranbaxy follows in the wake of a consent decree issued by US FDA in January 2012 which tightens scrutiny of Ranbaxy’s quality control and reporting measures.

Apotex gains reprieve after Merck loses ruling―but for how long

Toronto-based pharmaceutical firm Apotex has won a stay of execution for its nasal spray generic product after a US District Court in New Jersey, USA, turned down a patent infringement claim by Merck & Co’s Schering-Plough unit.

Generic Adderall XR approved in the US

Shire announced on 23 June 2012 that it had lost its battle to protect its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts). FDA approved the abbreviated new drug application (ANDA) from Actavis, a unit of US generics company Watson Pharmaceuticals, for the ADHD drug on 22 June 2012.

China follows the Indian and Thai route to affordable drugs

China announced measures for the Compulsory Licensing for Patent Implementation in a statement on 1 May 2012. The country is saying that it intends to become a generics producer for the domestic and possibly the international market.

Management of drugs shortages

The number, range and duration of drug shortages in the US appear to be, at best, maintaining the levels seen in the recent past. It is now becoming essential for institutions to draft formal policies and procedures to manage them. An article by two hospital pharmacists summarises the information available and outlines the steps needed to make the best of the situation [1].

Mylan moving ahead

Three announcements in three days, in four different countries―Mylan is continuing to make progress in generics.

Attitudes and beliefs are powerful influences on generics use

While generic drugs have the potential to provide significant savings in healthcare costs, and numerous financial incentives are in place, the generics substitution rate in Switzerland was, until recently, lower than expected. A report by Decollogny et al. shows that attitudes and beliefs among patients and physicians have a powerful influence on prescribing practice, suggesting that educational campaigns could potentially provide a significant boost to generics use [1].

Which antiplatelet agent? The debate intensifies

Plavix (clopidogrel) has been a blockbuster drug. The lower cost of generic clopidogrel, available for the first time since 17 May 2012 [1], is intensifying debate among cardiologists over how to make sure patients get optimal benefit from any blood-thinning treatment.

Teva won’t sell generic atorvastatin

Teva has decided not to market its own generic version of Lipitor (atorvastatin), Pfizer’s blockbuster cholesterol-lowering drug that recently came off patent. The decision comes despite the fact that FDA granted tentative approval for Teva’s generic version of atorvastatin at the end of 2011. Teva America’s CEO, Mr William Marth told The Economic Times, ‘we’ve made a really hard choice on not launching atorvastatin.’ He forecasts that the decision not to launch certain products such as atorvastatin and simvastatin will cost the firm about US$150 million.

Hospira recalls overfilled hydromorphone hydrochloride vials

Hospira first alerted FDA in April and May 2012 of overfilled cartridges containing morphine and hydromorphone. Subsequent investigation by the company has revealed that as many as 280 batches of 15 different Carpuject pre-filled cartridge products, which were manufactured between June 2010 and February 2012, could have contained more medication than is stated on the label [1].

Efficacy and tolerability of generic and brand-name atorvastatin

A generic formulation of atorvastatin was developed in Korea and approved by Korea Food and Drug Administration on 1 July 2008. This clinical trial was conducted at ten clinical centres in Korea between September 2008 and May 2010 for the purposes of marketing the generic formulation [1].

Increased use of generic statins proves cost effective in Australia

A recent study concluded that closing the statin ‘treatment gap’ using generics was cost-effective in the secondary prevention of coronary artery disease (CAD) in Australia [1].

Generics makers cannot gain access to some brand-name drugs

Generics manufacturers trying to create generics for certain drugs are having problems gaining access to samples of the brand-name drugs due to restrictions on supply put in place by FDA.

Generics sustainability to be investigated by UK DoH and industry

The British Generic Manufacturers Association (BGMA) and the UK Department of Health (DoH) have agreed to work together to investigate potential challenges to the sustainability of the generics industry in the UK.

Clopidogrel goes off-patent: last of the old-style blockbusters

The blockbuster drug Plavix (clopidogrel), used to prevent clotting in some heart patients, comes off patent in the US on 17 May 2012, bringing to an end the run of spectacularly well-selling traditional medicines.

Generic atorvastatin could save NHS GBP 350 million a year

Generics of Pfizer’s blockbuster cholesterol treatment Lipitor (atorvastatin) could save the National Health Service (NHS) in the UK a whopping GBP 250 million or more during the coming years, following loss of patent exclusivity.

Can generic competition succeed at reducing cost of atorvastatin?

The generic form of the cholesterol-lowering drug Lipitor (atorvastatin) has the potential for significant cost savings for payers following its introduction in November 2011. However, ‘aggressive business tactics’ by Pfizer may stifle generics competition and so prevent prices from falling as much as predicted.

Also noted on generics: 11 May 2012

Out-of-pocket expenses decline in US
Patients with insurance spent US$1.8 billion less on out-of-pocket expenses for medicines in 2011 compared to 2010. In 2011 patient’s out-of-pocket expenses totalled US$49 billion compared to US$50.8 billion in 2010.

The average co-payment also declined, especially for seniors participating in the Medicare Part D program. The average co-payment for unbranded generics was US$5.63 and US$10.34 for Medicare Part D and other insured patients respectively. This compares to brand-name medicine prices of US$37.61 and US$40.35 respectively. In fact, in 2011, more than 75% of medicines carried a co-payment of US$10 or less.

Source: IMS Institute

Sandoz to gain generic dermatology specialist Fougera

Swiss pharma giant, Novartis, announced on 2 May 2012 that the company had signed a deal for Sandoz, its generics unit, to acquire speciality generics dermatology business Fougera Pharmaceuticals (Fougera) for US$1.525 billion in cash.

Comparison of brand-name and biosimilar etanercept in Korea

A study comparing pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg) in Korea reported by Gu et al has shown that the reference drug and the test biosimilar met the standard criteria for assuming bioequivalence as defined by Korean regulatory authorities [1].

Amgen buys Turkish generics manufacturer

US biotechnology giant Amgen announced on 25 April 2012 that the company will pay US$700 million to gain a majority share (95.6%) in Turkish generics company Mustafa Nevzat Pharmaceuticals (MN).

Watson now third largest generics company with Actavis acquisition

Watson Pharmaceuticals (Watson) has confirmed a definitive agreement to acquire privately-owned generics firm Actavis for an upfront payment of Euros 4.25 billion. The acquisition of Actavis makes Watson the third largest generics company in the world, with US$8 billion in combined revenue expected during 2012.

US Supreme Court rules against generics delaying tactics

On 17 April 2012, the US Supreme Court ruled in favour of India-based generics company Sun Pharma in its case against Danish pharmaceutical company, Novo Nordisk, a case that could have provided a route for brand-name drug companies to delay generics competition.

FDA approves generic vancomycin capsules

On 11 April 2012 India-based Strides Arcolab (Strides) announced that it had received FDA approval for its generic version of Baxter’s antibiotic Vancocin (vancomycin).

Cheap generic drug stops fatal bleeding but gets little use

According to a systematic review of data, use of a cheap generic drug could potentially save many trauma patients every year [1].

Also noted on generics: 13 April 2012

Patents on Taxotere invalid
On 9 April 2012, two patents for sanofi-aventis’ cancer drug Taxotere (docetaxel) were ruled invalid and unenforceable by a US court, coming as good news for generics manufacturers Apotex and Hospira.

Taxotere (docetaxel) is a chemotherapy drug usually given to treat breast cancer, prostate cancer and non-small cell lung cancer. The drug, which is a follow-on from Taxol (paclitaxel), still generated Euros 922 million during 2011 for sanofi-aventis, despite a 57% reduction since the start of generic drug competition in 2010.

Source: Bloomberg

Generic quetiapine launched but the fight goes on

The news of AstraZeneca’s failed attempts to delay generic competition for its blockbuster antipsychotic drug Seroquel (quetiapine fumarate) has caused a gold rush among generic companies, who are falling over each other to launch their generic versions.

FDA approves first generics to treat high blood pressure and kidney disease

On 2 April 2012, Teva Pharmaceutical Industries (Teva) announced that it had launched generic versions of sanofi-aventis’ high blood pressure treatments Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide) in the US.

Patients do not talk about generics with doctors

One of the main financial concerns expressed by adults in the US is the cost of medications and medical bills, however, despite this fact, very few patients talk about the price of prescription medicines with their physicians, according to Consumer Reports' monthly nationally representative survey [1].

Bill introduced to ensure generics get 180-day exclusivity

Congressman Frank Pallone and Congressman Brett Guthrie introduced a new bill to the US Senate on 29 March 2012 to amend the US Food, Drug and Cosmetic Act in order to ensure that generics manufacturers get their 180-day exclusivity.

Novartis introduces branded generic tacrolimus

Novartis announced on 3 April 2012 that it had launched a branded generic version of Astellas Pharma’s immunosuppressant Prograf (tacrolimus).

Also noted on generics: 6 April 2012

Tropsium XR patents declared invalid
Watson Pharmaceuticals confirmed in early April 2012 that the United States District Court for the District of Delaware has ruled that four patents for Sanctura XR (trospium chloride extended-release capsules) are invalid. Watson’s Abbreviated New Drug Application for a generic version of the overactive bladder treatment is pending with FDA.

According to IMS Health data Sanctura XR had US sales of approximately US$68 million for the twelve months ending 29 February 2012.

Source: Watson

AstraZeneca losing fight against generic quetiapine

AstraZeneca’s is losing the fight it seems to protect its blockbuster antipsychotic drug Seroquel (quetiapine fumarate).

Attitudes towards prescribing generics in Malaysia

A recent study carried out in Malaysia has shown that pharmacists in the country have a lack of confidence in generic medicines produced by local pharmaceutical companies [1].

FDA approves first generic ibandronate sodium osteoporosis drugs

FDA announced on 19 March 2012 the approval of the first generics of GlaxoSmithKline’s and Roche’s postmenopausal osteoporosis drug Boniva (ibandronate sodium).

Also noted on generics: 30 March 2012

Watson in talks to buy Actavis
US generics manufacturer Watson is rumoured to be making a bid for Icelandic generics company Actavis, according to Bloomberg, creating one of the world’s largest generics companies in the process. Watson is reportedly in private talks to pay around Euros 4.5 billion for Actavis, with a deal likely to be announced after Easter.

Source: Bloomberg

Generic rosuvastatin approved in Canada

Generics giant Mylan Pharmaceuticals (Mylan) announced on 15 March 2012 that it had received approval from Health Canada for a generic version of AstraZeneca’s leading cholesterol drug Crestor (rosuvastatin). The approval covers tablets in 5, 10, 20 and 40 mg strengths.

Brand-name atorvastatin cheaper than generics

Despite generics of Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) being available in the US since the patent expired in November 2011, many patients are still receiving the brand-name drug [1].

AstraZeneca sues FDA over generic quetiapine

In an attempt to prevent competition from generics to its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate), pharma giant AstraZeneca has filed a lawsuit against FDA.

Also noted on generics: 22 March 2012

Watson confirms patent challenges
Watson Pharmaceuticals (Watson) confirmed that lawsuits had been filed against the generics company regarding two Abbreviated New Drug Applications it had submitted to FDA.

Forest Laboratories filed a lawsuit against Watson on 13 March 2012 to try to prevent a generic version of Bystolic (nebivolol) used for treatment of hypertension, until the ‘040’ patent that Forest licenses from Janssen Pharmaceutica expires in December 2021.

Abbott Laboratories filed a lawsuit against Watson on 16 March 2012 to prevent commercialisation of a generic version of Niaspan (Niacin) extended release tablets until the ‘428’ and ‘035’ patents expire in September 2013.

Source: Watson

Cost savings due to prescribing of generic PPIs and statins in Scotland

Significant cost savings can be made by governments by encouraging prescribing of generics rather than brand-name drugs. In Scotland, in an effort to control medicines expenditure, measures were introduced in 2000 to encourage the prescribing of generic proton pump inhibitors (PPIs) and statins [1].

Generics reach 80% and play a critical role in reducing costs

Prescription drug spending in the US reached US$307 billion in 2010–an increase of US$135 billion since 2001–and comprised approximately 12% of all healthcare spending in the country, according to a report published on 31 January 2012 by the US Government Accountability Office (GAO).

First generic atorvastatin launched in Australia and Europe

On 6 March 2012, Ranbaxy announced that it had obtained, pursuant to a settlement agreement with Pfizer, the rights to an early entry of its generic atorvastatin in Germany, Italy, The Netherlands and Sweden.

Indian Government issues first compulsory licence

The Indian Government has issued a compulsory licence for the first time, allowing India-based drugmaker Natco Pharma (Natco) to launch a generic version of Bayer’s liver and kidney cancer drug Nexavar (sorafenib) before the patent expires on the originator.

Also noted on generics: 16 March 2012

Prescription drugs to be directly dispensed by pharmacists
FDA has announced a meeting to be held on 22 and 23 March 2012 to discuss the possibility of allowing some prescription drugs to be dispensed by pharmacists without the need for a physician’s prescription.

Source: Federal Register

Data publication may address generics misperceptions

Wider publication of bioequivalence, safety, or efficacy data to demonstrate the effectiveness of generic drug compounds may help to nullify the last remaining anti-generics argument: that generics do not achieve the same therapeutic standards as the original branded drug.

Generics saved Germany more than 25% in 2011

The increased use of generics in Germany has brought about record savings of more than 25% in 2011 compared with 2010. The increased savings have been attributed to the success of measures put in place by the German Government to encourage generics substitution and competition in the public health insurance funds off-patent market.

Savings to be made from generics use in Australia

Increasing the use of generic drugs in Australia could generate ‘hundreds of millions of dollars in savings’ for Australia’s Pharmaceutical Benefits Scheme (PBS) in 2012 [1], ‘eliminating the need for further PBS cuts’, according to Australia’s Generic Medicines Industry Association (GMiA).

Impact of measures to encourage generics prescribing in Scotland

Since 2000, measures have been introduced in Scotland in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins [1]. The impact of these measures on the prescribing practices in Scotland has been positive. Generics use has increased, and costs for the Scottish government have decreased.

FDA approves new suppliers to alleviate cancer drug shortages

Two new suppliers of cancer treatments have been approved by FDA to try to alleviate ongoing US drug shortages.

Hospira re-joins Generic Pharmaceutical Association

Hospira announced on 23 February 2012 that the company had re-joined the Generic Pharmaceutical Association (GPhA). Hospira, self-proclaimed leader in injectable generics, added that it is dedicated to ‘advancing wellness’, a goal that matches well with the GPhA’s core purpose of bringing affordable medications to patients who need them.

Apotex clopidogrel at-risk launch costs US$442 million

Sanofi and Bristol-Myers Squibb (BMS) announced on 8 February 2012 that generic drugmaker Apotex had paid a whopping US$442 million in damages in the Plavix (clopidogrel bisulfate) patent infringement case against Apotex.

Prescribing of generic PPIs and statins in Scotland

In Scotland, a series of measures have been introduced since 2000 in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins [1]. Some of the measures introduced include:

Commission urges Greece to make parallel trade fair

The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’.

Sun comes under fire from Pfizer

Sun Pharmaceutical Industries (Sun Pharma) is coming under fire from Pfizer, as the generics major is sued for violating patents on Pfizer’s Protonix (pantoprazole).

WHO definitions of generics

Confusion often surrounds terms used in the global field of generics and biosimilars.

Watson files ANDA for generic Beyaz

Watson Pharmaceuticals (Watson) announced on 10 February 2012 that it had filed an Abbreviated New Drug Application (ANDA) with FDA for a generic version of Bayer HealthCare’s (Bayer) leading oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate).

Italian physicians’ negative attitude to generics

A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.

Sandoz submits ANDA for generic treprostinil

US drugmaker United Therapeutics announced on 6 February 2012 that it had received a Paragraph IV Certification Notice Letter from Sandoz, the generics division of Swiss-based drug giant Novartis. The notice letter stated that Sandoz had submitted an Abbreviated New Drug Application (ANDA) to FDA requesting approval to market a generic version of the 10 mg/mL strength of Remodulin (treprostinil) injection.

Tentative FDA approval for generic HIV treatment

FDA announced on 31 January 2012 that it had given tentative approval for generic versions of GlaxoSmithKline’s (GSK’s) blockbuster AIDs treatment Epzicom (abacavir sulfate and lamivudine). The tentative approval enables India-based generics companies Cipla and Mylan to sell their generics to US aid programmes, but not yet in the US.

Ranbaxy consent decree with FDA submitted to court

Ranbaxy Laboratories (Ranbaxy) announced on 26 January 2012 that the consent decree with FDA that was signed on 20 December 2011 has been filed with the United States District Court for the District of Maryland.

Generic and biosimilar user fee recommendations sent to Congress

FDA has sent recommendations for user fee programmes, including those covering generic and biosimilar drugs, to US Congress. It is hoped that the fees will help speed up the delivery of safe and effective drugs to patients.

Italy asked to comply with marketing rules for generics

The news that the European Commission (EC) had finally issued a formal call on 26 January 2012 for Italy to comply with EU rules on the marketing authorisation of generic medicines was welcomed by the European Generic medicines Association (EGA) together with the Italian association for generic medicines (Assogenerici).

Generics market to experience strong growth in 2010–2017

The global market for generic drugs will experience strong growth in the coming years due to patent expiries of blockbuster drugs worth US$150 billion between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper generics.

Watson expands in Asia with Ascent Pharmahealth

US generics manufacturer Watson Pharmaceuticals announced on 24 January 2012 that it had acquired Ascent Pharmahealth, the Australia and Southeast Asia generics subsidiary of Strides Arcolab, in a deal worth Australian dollars (A$) 375 million.

Factors important for generics substitution in Finland

What factors do patients take into account when deciding to accept or reject generics substitution? This is the question asked in a recent research article [1].

Teva outlines expansion plans in Asia

Generics giant Teva is looking for deals in Asia, which the company believes will see strong future expansion in the use of generics.

Generic nasal spray approved by FDA

India-based generics manufacturer Wockhardt announced on 10 January 2012 that it had received final approval from FDA for marketing a generic version of GlaxoSmithKline’s nasal spray allergy treatment Flonase (fluticasone).

Teva gains tentative approval for generic atorvastatin

Teva announced on 1 December 2011 that it had received tentative approval from FDA for its generic version of Pfizer’s blockbuster cholesterol-reducing medication Lipitor (atorvastatin).