A dozen companies have submitted letters in response to FDA's March 29 request for "comments from interested parties" on Norvasc (amlodipine besylate) exclusivity issues. Last week, as we reported here, FDA promised the U.S. District Court for the District of Columbia that by Wednesday, April 11, it will decide whether to approve any ANDAs for generic Norvasc besides Mylan's. Meanwhile, the district court has allowed Teva, Apotex and Mutual to intervene in the case for the limited purpose of responding, if necessary, to Mylan's motion for a temporary restraining order against FDA.
In its March 29 request for comments, FDA presented the following questions:
- What date controls FDA's giving effect to the decision in Pfizer v. Apotex holding that Pfizer's patent on Norvasc is invalid?
- If FDA must await the issuance of the Federal Circuit mandate, does pediatric exclusivity bar approval of all unapproved ANDAs in the meantime?
- If and when the Apotex decision is implemented, what is the effect of the decision on the obligation of an ANDA applicant to change its patent certification?
- If and when the Apotex decision is implemented and the patent is treated as invalid, does pediatric exclusivity attach to Pfizer's patent with respect to any unapproved ANDAs?
- Does 180-day exclusivity triggered before a patent expires continue to bar approvals of other ANDAs after the patent expires?
The letters submitted in response are posted at this FDA web-page. The positions are summarized very briefly below:
- Pfizer was awarded pediatric exclusivity on Norvasc and argues that all unapproved amlodipine ANDAs (i.e., all ANDAs besides Mylan's) remain subject to that exclusivity.
- Mylan was the first to file a Norvasc ANDA with a paragraph IV certification and claims it is entitled to 180-day exclusivity.
- Apotex argues it is the only company not subject to Pfizer's pediatric exclusivity because it is the only company having a Federal Circuit decision in its favor.
- Teva argues that neither Pfizer nor Mylan is entitled to exclusivity.
- Mutual argues that no other ANDAs may be approved until Pfizer's pediatric exclusivity or Mylan's 180-day exclusivity expires in September.
- Caraco argues that Mylan's 180-day exclusivity was triggered upon launch and extends to September 23, 2007.
- Roxane suggests that all tentatively approved ANDAs should be granted final approval when the Federal Circuit issues a mandate.
- Watson argues that Mylan's 180-day exclusivity ended when Pfizer's patent expired, and that Pfizer is not entitled to pediatric exclusivity.
- Daiichi Sankyo filed a paragraph III certification in its 505(b)(2) application and says it is subject to Pfizer's pediatric exclusivity.
- Aurobindo, an API supplier, argues that the Federal Circuit decision triggered Mylan's 180-day exclusivity period.
- Orchid filed a paragraph III certification in its ANDA and takes no position on the questions.
- Medco, a pharmacy benefit manager, argues that FDA should grant final approval to all tentatively approved amlodipine ANDAs now.
FDA Law Blog is expected to have more information on this interesting case.
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