Biktarvy generics delayed as Gilead (GILD) settles key patent disputes

Rhea-AI Filing Summary

Gilead Sciences, Inc. has entered into settlement agreements to resolve patent litigation over its HIV treatment Biktarvy with generic manufacturers Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd. These companies had sought U.S. approval to sell generic versions of Biktarvy.

Under the agreements, which include standard acceleration provisions, no generic entry is expected in the United States before April 1, 2036 for Biktarvy tablets containing bictegravir 50 mg, emtricitabine 200 mg and tenofovir alafenamide 25 mg. Gilead also reiterates that these statements are forward-looking and subject to risks such as intellectual property challenges, litigation outcomes and regulatory changes.

Insights

Biopharma and IP analyst

Gilead settles Biktarvy patent cases, pushing expected U.S. generic entry to 2036.

Gilead Sciences has reached settlement agreements with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd. covering U.S. patent disputes over Biktarvy, its fixed-dose HIV tablet. These companies had filed abbreviated new drug applications to market generics, and the agreements collectively address that challenge.

The settlements specify that, subject to standard acceleration provisions, no generic entry is expected in the United States before April 1, 2036 for Biktarvy tablets containing bictegravir 50 mg, emtricitabine 200 mg and tenofovir alafenamide 25 mg. The arrangements therefore set a clear reference date for expected loss of exclusivity for this dosage form.

The company emphasizes that these are forward-looking statements and that outcomes could differ due to intellectual property challenges, litigation developments, regulatory changes or government actions, as outlined in its Form 10-Q for the quarter ended June 30, 2025. Future company filings may further detail any additional settlements, patent changes or regulatory events affecting Biktarvy’s exclusivity.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

0000882095false00008820952025-10-062025-10-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): October 6, 2025

GILEAD SCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware			000-19731			94-3047598
(State or Other Jurisdiction of Incorporation)			(Commission File No.)			(IRS Employer Identification No.)

333 Lakeside Drive, Foster City, California

(Address of principal executive offices)

94404

(Zip Code)

650-574-3000

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value, $0.001 per share

GILD

The Nasdaq Global Select Market

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 7.01    Regulation FD Disclosure.

On October 6, 2025, Gilead Sciences, Inc., a Delaware corporation (“Gilead”), announced that it has entered into settlement agreements (“Agreements”) to resolve the patent litigations with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd., generic manufacturers that filed abbreviated new drug applications with the U.S. Food and Drug Administration to market generic versions of Biktarvy®. Under the Agreements, which are subject to standard acceleration provisions, no generic entry is expected prior to April 1, 2036 in the United States for Biktarvy tablets containing bictegravir (50 mg), emtricitabine (200 mg) and tenofovir alafenamide (25 mg).

This filing includes forward-looking statements that are subject to the safe harbors provided under the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statement other than statements of historical fact are forward-looking statements, including statements regarding patent protection and estimated loss of exclusivity for our products, and involve risks and uncertainties that may cause actual results or outcomes to differ materially. These risks and uncertainties include challenges to intellectual property, adverse litigation or government action, changes to laws and regulations applicable to our industry, as well as other risks and uncertainties described in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as filed with the U.S. Securities and Exchange Commission (the “SEC”). The forward-looking statements included in this filing are made only as of the date hereof unless otherwise specified. Except as required under federal securities laws and the rules and regulations of the SEC, Gilead does not undertake, and specifically declines, any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after this filing.

The information in Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01    Financial Statements and Exhibits.

(d)     Exhibits

Exhibit Number						Description
104						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 hereunto duly authorized.

GILEAD SCIENCES, INC.

(Registrant)

/s/ DEBORAH H. TELMAN

Deborah H. Telman
EVP, Corporate Affairs, General Counsel and Corporate Secretary

Date: October 6, 2025

FAQ

What did Gilead Sciences (GILD) announce regarding Biktarvy?

Gilead Sciences announced that it entered into settlement agreements resolving U.S. patent litigation over its HIV medicine Biktarvy with generic manufacturers Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd.

When are generic versions of Biktarvy expected to enter the U.S. market according to GILD?

Under the settlement agreements, no generic entry is expected in the United States before April 1, 2036 for Biktarvy tablets containing bictegravir 50 mg, emtricitabine 200 mg and tenofovir alafenamide 25 mg.

Which generic companies were involved in the Biktarvy patent settlements with Gilead (GILD)?

The settlements cover patent litigations with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd., which had filed abbreviated new drug applications to market generic Biktarvy.

Does Gilead provide any cautions about the Biktarvy exclusivity timeline?

Yes. Gilead notes that statements about patent protection and estimated loss of exclusivity are forward-looking and subject to risks such as intellectual property challenges, adverse litigation outcomes, regulatory changes and government actions.

Where does Gilead (GILD) say investors can find more risk details related to Biktarvy?

Gilead refers to the risk factors described in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the U.S. Securities and Exchange Commission.

Is the information about the Biktarvy settlements considered filed for liability purposes?

No. The company states that the information in Item 7.01 is furnished, not deemed "filed" under Section 18 of the Exchange Act, and is not automatically incorporated by reference into other Securities Act or Exchange Act filings.