Axsome Therapeutics, Inc 8-K, filed Feb 13, 2023
Axsome Therapeutics, Inc. (AXSM)
About this 8-K
Axsome Therapeutics, Inc filed this 8-K on February 13, 2023, reporting on events of February 10, 2023.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On February 10, 2023, Axsome Therapeutics, Inc. (the “Company”) received a Paragraph IV Certification Notice Letter (the “Notice Letter”) from Teva Pharmaceuticals, Inc. (“Teva”), providing notification to the Company that Teva has submitted an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture, use, or sell a generic version of Auvelity® (dextromethorphan HBr-bupropion HCl).
In the Notice Letter, Teva alleges that four of the patents listed in the FDA Orange Book for Auvelity, U.S. Patent Numbers 10,780,064; 10,925,842; 10,940,124; and 10,966,942, each of which expires in 2040, are invalid, unenforceable, or will not be infringed by Teva's manufacture, use, or sale of the generic product described in its ANDA submission.
The Paragraph IV Certification does not challenge any of the remaining Orange Book listed patents for Auvelity which have expirations out to 2034.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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 thereunto duly authorized.
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Axsome Therapeutics, Inc. |
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Date: |
February 13, 2023 |
By: |
/s/ Herriot Tabuteau, M.D. |
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Name: Title:
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Herriot Tabuteau, M.D. |