Depomed (DEPO) Reports Submission of ANDA for Generic Zipsor
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Depomed, Inc. (Nasdaq: DEPO) is disclosing that as of June 19, 2013 the website of the U.S. Food and Drug Administration (“FDA”) indicates that an Abbreviated New Drug Application (“ANDA”) for a generic version of Zipsor® (diclofenac potassium) has been submitted. Depomed has not received a Paragraph IV certification with respect to this ANDA filing and does not know the identity of the party that filed the ANDA.
Depomed intends to vigorously enforce its intellectual property rights relating to Zipsor. Zipsor is protected by five patents, all of which are listed in the FDA’s approved Drug Products with Therapeutics Equivalence Evaluations, commonly known as the Orange Book. Under the FDA’s rules and regulations, if Depomed initiates a patent infringement suit to defend the patents identified in any Paragraph IV notice it receives within 45 day after its receipt of such notice, the FDA is prevented from approving the ANDA until the earlier of 30 months after the date of receipt of such notice, the expiration of the patents at issue or a decision in the infringement case that all of such patents are not infringed or invalid. One of the patents listed in the Orange Book for Zipsor expires in 2019 and four in 2029.
Depomed intends to vigorously enforce its intellectual property rights relating to Zipsor. Zipsor is protected by five patents, all of which are listed in the FDA’s approved Drug Products with Therapeutics Equivalence Evaluations, commonly known as the Orange Book. Under the FDA’s rules and regulations, if Depomed initiates a patent infringement suit to defend the patents identified in any Paragraph IV notice it receives within 45 day after its receipt of such notice, the FDA is prevented from approving the ANDA until the earlier of 30 months after the date of receipt of such notice, the expiration of the patents at issue or a decision in the infringement case that all of such patents are not infringed or invalid. One of the patents listed in the Orange Book for Zipsor expires in 2019 and four in 2029.
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