Generics

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: