Indian Pharma giant Sun Pharma (announced in a press release Here ) that its subsidiary
Caraco Pharma (announced in a press release Here ) has executed a settlement agreement with innovator MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland regarding the submission of an Abbreviated New Drug Application (ANDA) for a generic version of Amifostine (Ethyol) 500 mg/vial injection (Ethyol) .
Caraco Pharma (announced in a press release Here ) has executed a settlement agreement with innovator MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland regarding the submission of an Abbreviated New Drug Application (ANDA) for a generic version of Amifostine (Ethyol) 500 mg/vial injection (Ethyol) .
Under the settlement agreement, MedImmune grants Caraco a license to certain patents, permitting Caraco to continue marketing a generic version of Ethyol in the United States. The settlement resolves the entirety of the litigations between the parties.
The following patents are listed in Orange Book for this product:
US5424471 (Expiry: July 31, 2012): Covers crystalline Amifostine composition
US5591731 (Expiry: July 31, 2012): Covers crystalline Amifostine composition with improved stability
US5994409 (Expiry: Dec 8, 2017): Method of use
Before settlement, both companies were in litigation (since 2004) on above patents in the United States District Court for the District of Maryland
Amifostine which is chemically, S-2-(3-Aminopropylamino) ethyl dihydrogen phosphorothioate (Ethyol) is used as an adjuvant in cancer treatment.
Earlier, Caraco got final approval from USFDA to market Amifostine (Ethyol) 500 mg/vial injection in March, 2008.
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