Replies to post #43458 on Biotech Values

[palindromy]

Re: Norvasc exclusivity

More relevant part I should have put in -

The proposed rule containing § 314.107(c)(1), published in the Federal Register of July 10, 1989
(54 FR 28872, 28929), proposed the requirement that the first ANDA applicant submitting a
paragraph IV certification be sued for patent infringement to obtain the 180-day exclusivity. This
interpretation was believed to be most consistent with the language of the Hatch-Waxman
Amendments and furthered the congressional intent to encourage challenges to patents that may
be invalid or unenforceable (54 FR 28872 at 28894). In response to a comment on the proposed
rule, FDA added a requirement to the final rule that the first ANDA applicant submitting a
paragraph IV certification successfully defend a patent infringement suit to be entitled 180-day
exclusivity. The "successful defense" requirement was established to eliminate "an incentive for
frivolous claims of patent invalidity or noninfringement because it would give ANDA applicants
exclusivity even if the applicant was unsuccessful in defending against the patent owner's lawsuit"
(59 FR 50338 at 50353).

[DewDiligence]

Generic Norvasc: Mylan is the one. Apotex’s
argument, detailed in #msg-18135829, was a
failed bluff to get MYL to the bargaining table.

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070418:MTFH01011_2...

>>
FDA Decides Against Additional Norvasc Generics

Wed Apr 18, 2007 6:42 PM ET

NEW YORK, April 18 (Reuters) - U.S. regulators have decided against approving generic versions of Pfizer Inc.'s <PFE> Norvasc blood-pressure drug other than an already launched generic version made by Mylan Laboratories Inc. <MYL>

The decision by the Food and Drug Administration came to light in a filing on Wednesday with the U.S. District Court for the District of Columbia.

Mylan launched its generic version of Norvasc last month. The generic drugmaker says it is entitled to 180 days as the lone generic Norvasc seller and has been seeking a temporary restraining order to bar other generic Norvasc approvals during that time.

Norvasc had U.S. sales of about $2.7 billion last year and has been Pfizer's second-biggest seller. Mylan launched generic versions of Norvasc after another court invalidated a Pfizer patent.

Canadian drugmaker Apotex had projected that no company would have the exclusivity period.

The FDA sought views on the issue before making its decision.

"FDA has decided not to approve (applications) other than Mylan's at this time," the court filing said.

Apotex and Teva Pharmaceutical Industries Ltd. <TEVA> are among the companies with tentative U.S. approval for amlodipine besylate, the generic name for Norvasc.
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