APOTEX INC get approval for its ANDA filing of DASATINIB tablet.
APOTEX INC is first ANDA with 180 days exclusivity eligibility for generic version of
SPRYCEL tablet.
Apotex Inc. (Apotex) complied with the requirements of section 505(j)(2)(B) of the FD&C Act, and that litigation was initiated against Apotex for infringement of the '746, '875, '856, and '725 patents within the statutory 45-day period in the United States District Court for the District of New Jersey [BristolMyers Squibb Company v. Apotex, Inc., and Apotex Corp., Civil Action No. 3:10-cv-05810, consolidated with Civil Action No. 11-6918]. The court issued an order of dismissal on September 12, 2013.
This exclusivity, which is provided for under section 505(j)(5)(B)(iv) of the FD&C Act, would begin to run from the date of the commercial marketing identified in section 505(j)(5)(B)(iv). The agency notes that Apotex failed to obtain tentative approval of this ANDA within 362 months after the date on which the ANDA was filed. See section 505(j)(5)(D)(i)(IV) of the FD&C Act (forfeiture of exclusivity for failure to obtain tentative approval). The agency is not, however, making a formal determination at this time of Apotex’s eligibility for 180-day generic drug exclusivity.
APOTEX INC is first ANDA with 180 days exclusivity eligibility for generic version of
SPRYCEL tablet.
Apotex Inc. (Apotex) complied with the requirements of section 505(j)(2)(B) of the FD&C Act, and that litigation was initiated against Apotex for infringement of the '746, '875, '856, and '725 patents within the statutory 45-day period in the United States District Court for the District of New Jersey [BristolMyers Squibb Company v. Apotex, Inc., and Apotex Corp., Civil Action No. 3:10-cv-05810, consolidated with Civil Action No. 11-6918]. The court issued an order of dismissal on September 12, 2013.
This exclusivity, which is provided for under section 505(j)(5)(B)(iv) of the FD&C Act, would begin to run from the date of the commercial marketing identified in section 505(j)(5)(B)(iv). The agency notes that Apotex failed to obtain tentative approval of this ANDA within 362 months after the date on which the ANDA was filed. See section 505(j)(5)(D)(i)(IV) of the FD&C Act (forfeiture of exclusivity for failure to obtain tentative approval). The agency is not, however, making a formal determination at this time of Apotex’s eligibility for 180-day generic drug exclusivity.
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