Biotech Values

[palindromy]

Re: Norvasc case/Apotex&Mylan

Thanks Dew for the reply.

Actually, I think Apotex is quite right in their belief.
Have attached below the relevant part which provides for 180 day exclusivity.
Seems like Mylan does not have exclusivity any more.. however they do have final approval already while Apotex will probably take - guess what - 6 months or so!

From http://www.fda.gov/CDER/GUIDANCE/2576fnl.pdf
"In the Federal Register of October 3, 1994 (59 FR 50338, 50367), FDA published the final rule
implementing the patent and marketing exclusivity provisions of the Hatch-Waxman
Amendments. The regulation implementing section 505(j)(5)(B)(iv) of the Act provides:
If an abbreviated new drug application contains a certification that a relevant
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patent is invalid, unenforceable, or will not be infringed and the application is for a
generic copy of the same listed drug for which one or more substantially complete
abbreviated new drug applications were previously submitted containing a
certification that the same patent was invalid, unenforceable, or would not be
infringed and the applicant submitting the first application has successfully
defended against a suit for patent infringement brought within 45 days of the
patent owner's receipt of notice submitted under § 314.95, approval of the
subsequent abbreviated new drug application will be made effective no sooner than
180 days from whichever of the following dates is earlier:
(i) The date the applicant submitting the first application first commences
commercial marketing of its drug product; or
(ii) The date of a decision of the court holding the relevant patent invalid,
unenforceable, or not infringed. (21 CFR 314.107(c)(1)) (emphasis added)"