The ABA Section of Antitrust Law presented a short, but very informative and interesting, teleconference on authorized generics today.  The speakers were Seth Silbert of Wilson Sonsini, Tim Gilbert of Gilbert’s LLP, and Jerry Swindell of Johnson & Johnson.  Mr. Silbert presented an introduction to the topic, Mr. Gilbert presented the generic drug industry’s perspective,…

Via the Antitrust Review, three ABA committees will be presenting a lunch seminar entitled "Who’s Drug is it Anyway?  Authorized Generics, Their Role in the Pharmaceutical Marketplace, and the FTC Study" on Thursday, September 14 from noon to 1:30 pm EST.  You may attend the seminar in person at Drinker Biddle & Reath’s Washington D.C.…

Prof. Jay Thomas recently wrote a new paper entitled "Authorized Generic Pharmaceuticals: Effects on Innovation".  The paper was publised by Congressional Research Service, of the Library of Congress. Prof. Thomas’s new paper provides a very nice, concise summary of the authorized generics issue.  After going through the basics of Hatch Waxman and how the practice…

The Generic Pharmaceutical Association (GPhA), the trade group representing generic drug makers, released a study today concluding that authorized generics do not save consumers money and ultimately will lead to higher drug prices.  GPhA’s study, conducted by a law professor and an economics professor, appears to be a reaction to PhRMA’s study, released last month,…

Senators Jay Rockefeller (D-WV), Patrick Leahy (D-VT), and Charles Schumer (D-NY) introduced a bill, S. 3695, last Thursday that would ban the sale of authorized generic drugs during the first ANDA filer’s 180 day exclusivity period.  The bill was introduced just hours after the Senate Special Committee on Aging held a hearing entitled "The Generic…

The Court of Appeals for the Fourth Circuit today affirmed a district court decision dismissing a lawsuit brought by Mylan Pharmaceuticals against the FDA, in which Mylan asserted that the FDA did not have the authority to approve an authorized generic of Proctor & Gamble’s Macrobid (nitrofurantoin).  The decision is consistent with Teva v. Crawford,…

Pfizer announced that its subsidiary, Greenstone Ltd., will begin marketing an authorized generic version of Pfizer's anti-depressant Zoloft as soon as Teva introduces its generic version, which could happen as early as today.  As reported by Reuters, Teva's share price fell 3.9% on the news.  Teva, through its acquisition of Ivax, received 180 days of…

The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade group representing innovator drug companies, released a new study yesterday concluding that authorized generic drugs lead to lower drug prices for consumers.  PhRMA commissioned IMS Consulting to conduct the study. According to PhRMA’s press release announcing the study: The analysis examined case studies with and…

The FTC has begun posting public comments relating to its proposed authorized generics study on its website.  The public comment period ended Monday. In addition to the comment by the Ohio Public Employees Retirement System, available on the FTC website, a helpful reader provided comments from the following consumer and public interest groups: AAI, CFA,…

Authorized generic drugs are essentially brand name drugs packaged and sold as generics by an innovator drug company under its own NDA, through either the innovator’s generic subsidiary or an independent generic drug company.  With increasing frequency, innovator drug companies are launching authorized generics simultaneously with the first ANDA filer’s launch of its generic drug…