Tonix Pharmaceuticals Holding Corp. (TNXP): Form 8-K filed 2026-11-13
- Accepted by EDGAR
- 2026-11-13 16:00 ET
- Event date
- 2026-11-13
- Accession no.
- 0001493152-26-051693
- Original filing
- SEC EDGAR filing index
AI summary of the filing text. It can contain mistakes; the original filing is authoritative.
Tonix files patent infringement complaint against Dr. Reddy’s over generic TONMYA
Tonix filed a patent infringement complaint against Dr. Reddy’s on November 13, 2026, over its application for a generic version of TONMYA. The complaint seeks to prevent FDA approval before the last asserted patent expires. The filing triggers a statutory stay of final FDA approval for up to 30 months, subject to applicable exceptions and court orders.
- Tonix filed the complaint in the United States District Court for the District of New Jersey on November 13, 2026.
- Dr. Reddy’s filed an ANDA for a generic version of TONMYA sublingual tablets, 2.8 mg.
- The complaint seeks to delay FDA approval until the last asserted patent expires.
- The filing triggers a stay of final FDA approval for up to 30 months, subject to applicable exceptions and court orders.
litigationregulatory
Items reported
- Item 8.01: Other Events
A voluntary disclosure of an event the company considers important to security holders that no other Item covers, such as a dividend declaration, a buyback program, litigation updates or product news.
Documents
| Type | Description | Document |
|---|---|---|
| 8-K | 8-K | form8-k.htm |
The summary above was generated by AI from the filing text and checked automatically against it. Read the original documents on SEC EDGAR. How to read an 8-K.