Generics

US court puts generic Gralise on hold

Generics/News | Posted 29/08/2014

US specialty drugmaker Depomed has received a favourable preliminary verdict in its case against generics manufacturer Actavis, which had applied to market a generic version of Depomed’s treatment for neuropathic pain, Gralise (gabapentin).

Trends in the financial burden of diabetes treatment

Generics/Research | Posted 22/08/2014

The number of adults diagnosed with diabetes in the US increased 75% between 2000 and 2010, resulting in 9% of the adult population with diabetes. The cost of health care for people with diabetes is over twice that of the population overall (2.3 times higher), partly as a result of complications associated with diabetes, including heart disease and stroke. Understanding trends in healthcare costs for this vulnerable and growing patient group will be key to disease management in the future.

Generics manufacturers focus on MS drug Ampyra

Generics/News | Posted 22/08/2014

Following news that Acorda Therapeutics (Acorda) was preparing to defend its intellectual property rights against a competitor’s application to the US Food and Drug Administration (FDA) to manufacture a generic version of its multiple sclerosis drug Ampyra (dalfampridine), Acorda is now facing at least six additional generics challenges.

Ranbaxy’s manufacturing woes benefit big pharma

Generics/General | Posted 22/08/2014

Import bans by the US Food and Drug Administration (FDA) on generics from four of Ranbaxy Laboratories’ (Ranbaxy) manufacturing sites have prevented the company from launching new generics, allowing brand-name manufacturers to benefit from their extended monopolies.

Right of appeal provision in CETA

Generics/Research | Posted 14/08/2014

The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1], with certain provisions being seen as causing the most harm.

Recalls call into question metoprolol generics

Generics/General | Posted 08/08/2014

Recent recalls have vindicated a cardiologist’s warnings about generic versions of a widely used heart drug, Toprol XL (metoprolol).

Actavis submits generic dalfampridine ANDA

Generics/News | Posted 08/08/2014

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Data protection provisions in CETA

Generics/Research | Posted 01/08/2014

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provisions are seen as the main culprits.

Generic valsartan approved in US

Generics/News | Posted 01/08/2014

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

India planning to extend pricing control to more drugs

Generics/General | Posted 01/08/2014

India is thought likely to increase the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

Patent term restoration provisions in CETA

Generics/Research | Posted 04/07/2014

Some of the provisions included in the Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada are seen as having the potential to have a negative affect on the generics industry in Canada [1].

Teva settles patent litigation over ProAir HFA

Generics/News | Posted 04/07/2014

The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).

Influence of CETA on generics

Generics/Research | Posted 27/06/2014

On 18 October 2013, the European Union (EU) and Canada reached a political agreement on the key elements for a Comprehensive Economic and Trade Agreement (CETA). However, CETA has been criticized for the fact that it affects intellectual property rights in Canada, but not the EU. Some of the provisions included in the agreement are seen as having the potential to have a negative affect on the generics industry in Canada.