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Generics/General

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

Generics/General | Posted 18/05/2012

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.

Also noted on generics: 11 May 2012

Generics/General | Posted 11/05/2012

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

Also noted on generics: 13 April 2012

Generics/General | Posted 13/04/2012

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

Also noted on generics: 6 April 2012

Generics/General | Posted 06/04/2012

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

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Savings to be made from generics use in Australia

Generics/General | Posted 09/03/2012

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).

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Bill introduced to ensure generics get 180-day exclusivity

Generics/General | Posted 06/04/2012

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.

Also noted on generics: 30 March 2012

Generics/General | Posted 30/03/2012

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

Also noted on generics: 22 March 2012

Generics/General | Posted 23/03/2012

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

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Generics saved Germany more than 25% in 2011

Generics/General | Posted 09/03/2012

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.

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

Generics/General | Posted 16/03/2012

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).

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Indian Government issues first compulsory licence

Generics/General | Posted 16/03/2012

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

Generics/General | Posted 16/03/2012

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

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FDA approves new suppliers to alleviate cancer drug shortages

Generics/General | Posted 02/03/2012

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

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WHO definitions of generics

Generics/General | Posted 24/02/2012

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

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Commission urges Greece to make parallel trade fair

Generics/General | Posted 24/02/2012

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

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Italian physicians’ negative attitude to generics

Generics/General | Posted 17/02/2012

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

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The pharmaceutical market in Brazil

Generics/General | Posted 09/12/2011

The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.

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European Commission investigates Johnson & Johnson and Novartis over delaying generics

Generics/General | Posted 28/10/2011

As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to determine whether they delayed the entry of a generic version of the fentanyl painkiller in The Netherlands. If the drugmakers had ‘contractual arrangements’ that hindered a generic drug, this would ‘potentially’ breach EU antitrust rules.

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Quality by design for generics by 2013

Generics/General | Posted 09/12/2011

Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.

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European Commission to investigate patent settlements again

Generics/General | Posted 04/03/2011

The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.