Elite Pharma files ANDA for generic anticoagulant
Elite Pharmaceuticals, Inc. filed a Current Report to highlight that it has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for a generic drug in the anticoagulant class.
Rhea-AI Filing Summary
Elite Pharmaceuticals, Inc. filed a Current Report to highlight that it has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for a generic drug in the anticoagulant class. The branded reference product generated $26 billion in sales for the twelve months ending March 2026, according to IQVIA, and currently has no generic competition.
The brand still has unexpired patents and regulatory exclusivities listed in the FDA’s Orange Book, so any future generic launch would depend on FDA approval and successfully addressing these protections. The press release with additional details is furnished as an exhibit and is treated as furnished, not filed, under securities laws.
Positive
- None.
Negative
- None.
Insights
Elite is targeting a very large anticoagulant market, but success depends on FDA review and patent challenges.
Elite has submitted an ANDA for a generic anticoagulant where the branded drug recorded $26 billion in sales for the twelve months ending March 2026. There is no existing generic, indicating a high-value but tightly protected market.
The reference product still benefits from unexpired patents and exclusivities listed in the Orange Book. Any approval and commercialization would require both FDA clearance and navigating these intellectual property protections. Forward-looking language emphasizes regulatory and legal uncertainties.
Future company disclosures may clarify the regulatory progress of this ANDA and any patent-related developments. Until those details emerge, the filing mainly signals Elite’s strategic intent to compete in a large therapeutic category rather than an immediate revenue change.
8-K Event Classification
Key Figures
Key Terms
Abbreviated New Drug Application regulatory
anticoagulants medical
Orange Book regulatory
forward-looking statements regulatory
exclusivity regulatory
FAQ
What did Elite Pharmaceuticals (ELTP) announce in this 8-K filing?
How large is the branded anticoagulant market targeted by Elite Pharmaceuticals (ELTP)?
Are there any existing generic versions of the anticoagulant targeted by Elite (ELTP)?
What hurdles must Elite Pharmaceuticals overcome for its generic anticoagulant ANDA?
Does this Elite Pharmaceuticals (ELTP) update immediately affect its financial results?
How is the press release in Elite Pharmaceuticals’ 8-K treated under securities laws?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
(Address of principal executive offices)
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ☐
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| OTCQB |
| Item 7.01 | Regulation FD Disclosure. |
On June 1, 2026, in a press release, Elite Pharmaceuticals, Inc., or Elite, reported that it had filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of an undisclosed drug product in the class of medications called anticoagulants.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings under the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release dated June 1, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
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.
| Dated: June 1, 2026 | ELITE PHARMACEUTICALS, INC. |
| By: | /s/ Nasrat Hakim | |
| Nasrat Hakim, President and CEO |
Exhibit 99.1
Elite Pharmaceuticals Announces Filing of Abbreviated New Drug Application with the U.S. Food and Drug Administration for Generic Anticoagulant Product
NORTHVALE, N.J. – June 1, 2026 – Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB: ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced that it has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for a generic drug product in the class of medications called anticoagulants.
IQVIA reported branded product sales for the twelve months ending March 2026 of $26 billion. There is no generic product on the market, and the brand has unexpired patents and exclusivity listed in the FDA’s Approved Drug Products with Therapeutic Equivalence (Orange Book). FDA approval and commercialization of a generic product depend on successful filing, FDA approval and addressing the unexpired patents and exclusivities.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite’s product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite’s filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com