FDA Refuses to Approve Any ANDAs for Generic Norvasc Besides Mylan's
by Aaron F. Barkoff
Orange Book Blog
Ever since March 22, when the Federal Circuit invalidated claims 1-3 of Pfizer's (PFE) last remaining unexpired patent on Norvasc--U.S. Patent No. 4,879,303--Pfizer, Mylan (MYL) and other ANDA filers have been scrambling. On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic. On March 26, the day after the '303 patent expired, Mylan filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from approving any other ANDAs for generic Norvasc. FDA asked all interested parties for their views on Pfizer's pediatric exclusivity and Mylan's 180-day exclusivity, and on April 5 FDA published those comments.
As ordered by the district court, FDA reached a decision regarding Norvasc exclusivity today. FDA's notice to the court announced: "FDA has decided not to approve ANDAs other than Mylan's at this time." According to FDA's decision letter, addressed "Dear ANDA Applicant/Holder for Amlodipine Besylate Tablets" (and submitted to the district court):
In sum, FDA has concluded:
In comments submitted to FDA on March 25 and April 5, Pfizer argued that FDA could not approve any other Norvasc ANDAs at least until the Federal Circuit issues a mandate from its March 22 decision, since only then would the decision become effective. Apparently, FDA agrees.
A mandate cannot issue until disposition of a petition for rehearing or rehearing en banc, which Pfizer timely filed on April 5 (click here for Pfizer's petition). If Pfizer's petition is granted, the mandate won't issue until the Federal Circuit makes a final decision following rehearing. If Pfizer's petition is denied, the Federal Circuit will issue the mandate seven days after the decision to deny the petition.
Thus, Mylan's 180-day exclusivity period ended just two days after it began, but Mylan retains de facto generic exclusivity by virtue of Pfizer's pediatric exclusivity. In other words, for now Mylan is riding Pfizer's coat-tails as the only supplier of generic Norvasc--at least until the Federal Circuit issues a mandate from its March 22 decision (when Apotex's ANDA will be granted final approval).
Moreover, it appears that even if the Federal Circuit issues a mandate before Pfizer's pediatric exclusivity expires on September 25, 2007, FDA is unlikely to approve any additional ANDAs other than Apotex's. That is because if, as seems likely, one or more of claims 4-11 of the '303 patent covers Norvasc, then the patent can remain properly listed in the Orange Book. In such a case, the remaining unapproved ANDAs will be subject to Pfizer's pediatric exclusivity. Therefore, unless another ANDA applicant successfully challenges FDA's decision, Mylan and Apotex likely will have the only Norvasc generics on the market until September 25.
Thanks to Kurt Karst of FDA Law Blog for passing along today's news.
Source: OrangeBookBlog.com
RELATED READING:
- Mylan Labs press release (4/18/07)
- "U.S. Decides Against Additional Norvasc Generics"--Reuters 4/18/07
- "$4.7B Generic Norvasc Goes Out of Bounds"--Daily News & Analysis, India 4/19/07
- "Matrix Labs is Grinning"--Daily News & Analysis, India 4/19/07
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Orange Book Blog
Ever since March 22, when the Federal Circuit invalidated claims 1-3 of Pfizer's (PFE) last remaining unexpired patent on Norvasc--U.S. Patent No. 4,879,303--Pfizer, Mylan (MYL) and other ANDA filers have been scrambling. On March 23, Mylan, the first ANDA filer, launched its generic version of Norvasc and Pfizer responded by launching an authorized generic. On March 26, the day after the '303 patent expired, Mylan filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from approving any other ANDAs for generic Norvasc. FDA asked all interested parties for their views on Pfizer's pediatric exclusivity and Mylan's 180-day exclusivity, and on April 5 FDA published those comments.
As ordered by the district court, FDA reached a decision regarding Norvasc exclusivity today. FDA's notice to the court announced: "FDA has decided not to approve ANDAs other than Mylan's at this time." According to FDA's decision letter, addressed "Dear ANDA Applicant/Holder for Amlodipine Besylate Tablets" (and submitted to the district court):
In sum, FDA has concluded:
- All of the unapproved ANDAs are currently blocked by Pfizer's pediatric exclusivity.
- If and when the mandate effectuating the panel's March 22 decision issues in the Apotex case, Apotex's ANDA will not be blocked by Pfizer's pediatric exclusivity.
- FDA cannot determine on the current record whether other ANDAs will continue to be blocked by pediatric exclusivity at that time.
- Mylan's 180-day marketing exclusivity terminated when the patent expired.
In comments submitted to FDA on March 25 and April 5, Pfizer argued that FDA could not approve any other Norvasc ANDAs at least until the Federal Circuit issues a mandate from its March 22 decision, since only then would the decision become effective. Apparently, FDA agrees.
A mandate cannot issue until disposition of a petition for rehearing or rehearing en banc, which Pfizer timely filed on April 5 (click here for Pfizer's petition). If Pfizer's petition is granted, the mandate won't issue until the Federal Circuit makes a final decision following rehearing. If Pfizer's petition is denied, the Federal Circuit will issue the mandate seven days after the decision to deny the petition.
Thus, Mylan's 180-day exclusivity period ended just two days after it began, but Mylan retains de facto generic exclusivity by virtue of Pfizer's pediatric exclusivity. In other words, for now Mylan is riding Pfizer's coat-tails as the only supplier of generic Norvasc--at least until the Federal Circuit issues a mandate from its March 22 decision (when Apotex's ANDA will be granted final approval).
Moreover, it appears that even if the Federal Circuit issues a mandate before Pfizer's pediatric exclusivity expires on September 25, 2007, FDA is unlikely to approve any additional ANDAs other than Apotex's. That is because if, as seems likely, one or more of claims 4-11 of the '303 patent covers Norvasc, then the patent can remain properly listed in the Orange Book. In such a case, the remaining unapproved ANDAs will be subject to Pfizer's pediatric exclusivity. Therefore, unless another ANDA applicant successfully challenges FDA's decision, Mylan and Apotex likely will have the only Norvasc generics on the market until September 25.
Thanks to Kurt Karst of FDA Law Blog for passing along today's news.
Source: OrangeBookBlog.com
RELATED READING:
- Mylan Labs press release (4/18/07)
- "U.S. Decides Against Additional Norvasc Generics"--Reuters 4/18/07
- "$4.7B Generic Norvasc Goes Out of Bounds"--Daily News & Analysis, India 4/19/07
- "Matrix Labs is Grinning"--Daily News & Analysis, India 4/19/07
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