Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Category: Authorized Generics
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The Federal Trade Commission announced earlier today that it has completed its study into the competitive effects of authorized generic drugs. The FTC's final report, entitled "Authorized Generic Drugs — Short-Term Effects and Long-Term Impact," was unanimously approved by the five-member commission and follows up on a 2009 interim report. The study was commenced upon…
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On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the next ten years. For more: statements from BIO and PhRMA; FDA Legislative Watch; Pharmalot; The Hill’s Congress Blog. Bayer…
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Apotex and an anonymous ANDA filer recently submitted new comments to FDA on ramipril 180-day exclusivity issues. Earlier this month, we summarized previous comments on the ramipril docket. Roxane Labs recently submitted new comments to FDA on acarbose 180-day exclusivity, and Impax indicated that it intends to do the same. Their submissions are available on…
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The House of Representatives passed an omnibus FDA bill on Wednesday. The Senate passed its own FDA bill in May. Differences between the two bills will be hammered out in conference committee, where follow-on biologics provisions may be tacked on. See coverage at: FDA Law Blog; Pharmalot; PhRMA press release; WSJ Health Blog. Business Standard…
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Barr Labs announced Monday that it has amended its paragraph IV certification with respect to Lilly’s Zyprexa Zydis patent to a paragraph III certification, and that Lilly has dropped its related patent suit against Barr. See also this AP article. FDA Law Blog had this post Tuesday about yet another new study on authorized generics.…
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AP published this report on yesterday’s House hearing on "reverse payment" settlements. AP also recently published this article on follow-on biologics legislation, entitled "Time is Running Out for Generic Biotech." Antitrust Review recently posted an update on the FTC’s authorized generics study. FDA Law Blog has a new post today on the most recent developments…
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Pharmalot had a post today, “Kennedy Circulates Biogenerics Bill,” regarding a new draft of a bill that would establish an abbreviated pathway for FDA approval of follow-on biologics. Rep. Jay Inslee (D-WA) and two co-sponsors introduced a new follow-on biologics bill in the House last week, H.R. 1956. See also Press Release; Bill Summary. In…
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Mylan announced in a press release today that it has launched its generic Norvasc (amlodipine besylate). Mylan’s generic launch follows the Federal Circuit’s decision yesterday, invalidating Pfizer’s patent on Norvasc. The case presents some very interesting issues involving the interaction between patent rights, pediatric exclusivity, and 180-day exclusivity. Last month, Mylan lost its patent challenge…
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Senator Jay Rockefeller (D-WV) has introduced S. 438, "The Fair Prescription Drug Act of 2007," which would ban the sale of authorized generic drugs during an ANDA applicant’s 180-day exclusivity period. The bill is cosponsored by Senators Kohl (D-WI), Leahy, (D-VT), and Schumer (D-NY). The same bill was proposed last year as S. 3695. Senator…
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Savient Pharms. v. Sandoz, No. 07-1081 (Fed. Cir.) On December 28, 2006, the Federal Circuit Court of Appeals denied Savient Pharmaceuticals’ motion for a preliminary injunction, pending appeal, to prevent Sandoz and Upsher-Smith from marketing their generic Oxandrin (Oxandrolone) products. Oxandrin, with annual sales of $60 million, is indicated for the promotion of weight gain…
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