UNITED STATES
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FORM
CURRENT REPORT
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SECURITIES EXCHANGE ACT OF 1934
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| Item 8.01. | Other Events |
Evofem Biosciences, Inc. (the “Company”) has received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Padagis Israel Pharmaceuticals Ltd. (“Padagis”) advising that Padagis has submitted an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking authorization from the FDA to manufacture, use or sell a generic version of PHEXXI® in the United States.
In the Notice Letter, Padagis states that it intends to market a generic version of PHEXXI® before the expiration of the Company’s patents listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) covering PHEXXI®, U.S. Patent Numbers: 10,586,855 (expiring March 2033); 11,337,989 (expiring May 2033) and 11,439,610 (expiring March 2033). Padagis’ Notice Letter states that its ANDA contains a Paragraph IV Certification alleging that these patents are invalid under various grounds.
Under the Food and Drug Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, after receipt of a valid Paragraph IV notice, the Company may bring a patent infringement suit in a federal district court against Padagis. If such a suit is commenced within 45 days of receipt of the Notice Letter, this triggers an automatic 30-month stay, which would prevent he FDA from issuing final approval of Padagis’ ANDA until the expiration of the stay.
The Company is currently assessing the Notice Letter and intends to vigorously defend its intellectual property rights relating to PHEXXI®.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EVOFEM BIOSCIENCES, INC. | ||
| Dated: May 5, 2023 | By: | /s/ Saundra Pelletier |
| Sandra Pelletier | ||
| Chief Executive Officer | ||
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