Cadila Healthcare and Zydus Pharmaceuticals (USA) Inc. have entered into an agreement in principle with Warner Chilcott Company LLC to settle all outstanding patent litigation related to Asacol HD (mesalamine) delayed-release tablets. The agreement remains subject to preparation and execution of definitive documentation.
Under the terms of the agreement in principle, Warner Chilcott Company will grant Cadila and Zydus a royalty-bearing license to market a generic version of its patented drug Asacol HD beginning on November 15, 2015 or earlier under certain circumstances, following receipt by Zydus of final approval from the US Food and Drug Administration (USFDA) of its Abbreviated New Drug Application (ANDA) for generic version of Asacol HD.
Alternatively, if Zydus does not receive USFDA approval of its generic version of Asacol HD by July 1, 2016, Zydus will be permitted to launch an authorized generic version of Asacol HD beginning on July 1, 2016.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1679.85 |
| Dr. Reddys Lab | 1333.05 |
| Cipla | 1305.85 |
| Zydus Lifesciences | 947.10 |
| Lupin | 2340.20 |
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