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Last Updated: March 3, 2021

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Litigation Details for MYLAN LABORATORIES LIMITED v. FOOD AND DRUG ADMINISTRATION (D.C. 2012)

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Small Molecule Drugs cited in MYLAN LABORATORIES LIMITED v. FOOD AND DRUG ADMINISTRATION
The small molecule drugs covered by the patent cited in this case are   Start Trial ,   Start Trial ,   Start Trial , and   Start Trial .

Details for MYLAN LABORATORIES LIMITED v. FOOD AND DRUG ADMINISTRATION (D.C. 2012)

Date Filed Document No. Description Snippet Link To Document
2012-10-02 1 including U.S. Patent Nos. 5,399,578 (“the ‘578 patent”); 5,972,990 (“the ‘990 patent”); and 6,294,197 (“the ‘…approving the NDA, FDA publishes this patent information in the Patent and Exclusivity Infoirnation Addendum…to each patent properly listed in the Orange Book for the NDA drug: (I) that there is no patent inforrnation…the listed patent, a so-called “paragraph III certification;” or (IV) that the listed patent is invalid… ‘197 patent”). FDA subsequently listed the ‘578, ‘990 and ‘197 patents in the Orange Book in connection External link to document
2012-12-27 56 the '578 patent), 5,972,990 (the '990 patent), and 6,294,197 (the '197 patent). Ranbaxy'… there is no patent information; (II) that the patent has expired; (III) that the patent is set to expire…the patent holder of the certification, and the patent holder then has 45 days to bring a patent infringement… on any patent that claims the drug or a method of using the drug. Id. FDA lists this patent information…Diovan. Id. at 3. Three patents for Diovan are listed in the Orange Book: U.S. Patent Nos. 5,399,578 (the External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

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