FDA Announces Measures to Improve Generic Drug Access

The Food and Drug Administration (FDA) im March 2004 announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product.

 Pirates and Corsairs - The difficult equation Pharma-Parallel Trade

“In the legal debate (…), with a little bit of imagination, the undertakings who dedicate themselves to parallel trade could be compared with the pirates and those who defend their intellectual property rights could be compared with the corsairs, who received the “corsair patent” from their Government to attack the ships of the enemy countries.

The continuing battle over Atorvastatin (Lipitor®)

In 2006, Pfizer’s product Lipitor (Atorvastatin) attained sales of US$ 11.7 billion. This was down by 3.6% from the figure for 2005, which disappointed Pfizer but still left it with enough turnover to make it a very attractive target for generic copies.

Biosimilars – inflated expectations?

It was the same Senator Waxman who cooperated in 1984 with Senator Hatch to introduce what became known as the Hatch-Waxman Act to introduce a simplified method of registration for generics.

World's largest patent database is now online

More than 63 million patent documents from 80 patent organisations worldwide can be searched via the International Patent Documentation Data Base, (INPADOCDB). It was created by merging and revising two existing databases of the European Patent Office (EPO).

Novel Approches about Semisolid Dosage Forms  

The new access in semisolid dosage forms by adding or applying some new approaches to improve them from bioavailability, efficacy, drug dosing  cost etc and  also techniques which may be launched recently, but not widely used.  

Vardenafil (Levitra®) - Opportunity for Proactive Generic Companies?

The recently released GenericsWeb Pipeline Developer patent report for Vardenafil  (Levitra®) highlights the importance of high quality patent information when considering development of generic equivalents in the early stages of a product’s life cycle.

Closing the access gap for health innovations: an open licensing proposal for universities

This article centers around a proposal outlining how research universities could leverage their intellectual property to help close the access gap for health innovations in poor countries. A recent deal between Emory University, Gilead Sciences, and Royalty Pharma is used as an example to illustrate how 'equitable access licensing' could be put into practice.