Ultragenyx settles DOJOLVI patent case with Esjay

Ultragenyx Pharmaceutical Inc. reports that it and Baylor Research Institute entered into a settlement agreement with Esjay Pharma regarding patent litigation over DOJOLVI® (triheptanoin) oral liquid.

Accepted by SEC EDGAR 08/11/2026 - 08:30 AM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

Ultragenyx Pharmaceutical Inc. reports that it and Baylor Research Institute entered into a settlement agreement with Esjay Pharma regarding patent litigation over DOJOLVI® (triheptanoin) oral liquid. Esjay had filed an Abbreviated New Drug Application seeking approval to market a generic DOJOLVI in the United States.

Under the settlement, Ultragenyx will grant Esjay a non-exclusive, royalty-free license to market its generic version of DOJOLVI starting January 1, 2033, extendable to July 1, 2033 if pediatric exclusivity is granted, subject to customary conditions and exceptions. Similar litigation with other ANDA filers remains pending, and the agreement will be submitted to the FTC and Department of Justice.

Positive

• Settlement sets a clear earliest-entry date for generic DOJOLVI (January 1, 2033, or July 1, 2033 with pediatric exclusivity), reducing near- to medium-term patent uncertainty.
• The license to Esjay is described as non-exclusive and royalty-free, suggesting no ongoing royalty burden to Ultragenyx while resolving this specific DOJOLVI patent dispute.

Negative

• Agreement grants Esjay the right to market a generic DOJOLVI in the U.S. starting as early as January 1, 2033, indicating future generic competition after that date.
• Similar patent litigation with other ANDA filers remains pending, so overall DOJOLVI patent-related legal exposure has not been fully resolved.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Generic entry date: January 1, 2033 Extended generic entry date with pediatric exclusivity: July 1, 2033 Settlement date: August 7, 2026

3 metrics

Generic entry date January 1, 2033 Earliest date Esjay may market its generic DOJOLVI under the license

Extended generic entry date with pediatric exclusivity July 1, 2033 Date from which Esjay may market generic DOJOLVI if DOJOLVI receives pediatric exclusivity

Settlement date August 7, 2026 Date Ultragenyx and Baylor Research Institute entered into the settlement with Esjay

Key Terms

Abbreviated New Drug Application, pediatric exclusivity, non-exclusive, royalty-free license, ANDA filers

4 terms

Abbreviated New Drug Application regulatory

"resulted from submission by Esjay of an Abbreviated New Drug Application"

An abbreviated new drug application is a regulatory submission used to gain approval to market a generic version of an already approved prescription medicine by showing it is equivalent in effect and safety to the original product, without repeating full clinical trials. For investors, an approval signals a lower-cost competitor entering the market that can quickly capture sales from the branded drug, similar to a generic knock‑off replacing a name‑brand item on store shelves.

pediatric exclusivity regulatory

"extended to July 1, 2033 if pediatric exclusivity is granted for DOJOLVI"

Pediatric exclusivity is a regulatory reward that gives a drug maker extra protected selling time—typically a six‑month extension—if the company conducts studies showing the medicine is safe and effective for children. For investors, it matters because that extra time is like a temporary shield that delays generic competition and can materially extend revenue from a product, affecting a drug’s cash flow, valuation and investment returns.

non-exclusive, royalty-free license financial

"the Company will grant Esjay a non-exclusive, royalty-free license to market its generic"

ANDA filers regulatory

"Similar patent litigation brought by the Company against other ANDA filers related to DOJOLVI"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Ultragenyx (RARE) announce regarding DOJOLVI patent litigation?

Ultragenyx disclosed a settlement with Esjay Pharma resolving patent litigation over DOJOLVI (triheptanoin) oral liquid. The dispute arose from Esjay’s ANDA filing to market a generic DOJOLVI in the United States.

When can Esjay start selling generic DOJOLVI under the Ultragenyx (RARE) settlement?

Esjay may market its generic DOJOLVI under a license starting January 1, 2033. This start date is extended to July 1, 2033 if DOJOLVI receives pediatric exclusivity, subject to conditions in the agreement.

What are the key terms of Ultragenyx’s license to Esjay for generic DOJOLVI?

Ultragenyx will grant Esjay a non-exclusive, royalty-free license to sell generic DOJOLVI beginning January 1, 2033, or July 1, 2033 with pediatric exclusivity, with conditions and exceptions customary for such patent settlement agreements.

Does the Ultragenyx (RARE) settlement end all DOJOLVI patent litigation?

No. The settlement resolves litigation with Esjay Pharma only. Ultragenyx states that similar patent litigation against other ANDA filers related to DOJOLVI remains pending in the U.S. District Court for the District of New Jersey.

Will regulators review the Ultragenyx–Esjay DOJOLVI settlement?

Yes. Ultragenyx states that the settlement agreement will be submitted to the Federal Trade Commission and the Department of Justice, as required by law for certain pharmaceutical patent settlements.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false000151567300015156732026-08-072026-08-07

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): August 07, 2026

Ultragenyx Pharmaceutical Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-36276	27-2546083
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
60 Leveroni Court
Novato, California				94949
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 415 483-8800

(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, $0.001 par value		RARE		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 8.01 Other Events.

On August 7, 2026, Ultragenyx Pharmaceutical Inc. (the “Company”) and Baylor Research Institute (“BRI”) entered into a settlement agreement with Esjay Pharma Private Limited and Esjay Pharma LLC (collectively, “Esjay”) resolving patent litigation related to the Company’s DOJOLVI® (triheptanoin) oral liquid. The litigation, which was filed in the United States District Court for the District of New Jersey, resulted from submission by Esjay of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration seeking approval to market a generic version of DOJOLVI in the United States. Under the terms of the settlement agreement, the Company will grant Esjay a non-exclusive, royalty-free license to market its generic version of DOJOLVI beginning January 1, 2033, which would be extended to July 1, 2033 if pediatric exclusivity is granted for DOJOLVI, subject to certain conditions and exceptions customary for agreements of this type. Similar patent litigation brought by the Company against other ANDA filers related to DOJOLVI remains pending in the U.S. District Court for the District of New Jersey.

As required by law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice. The description of the settlement agreement contained herein does not purport to be complete.

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.

			Ultragenyx Pharmaceutical Inc.
Date:	August 11, 2026	By:	/s/ Howard Horn
			Howard Horn  Executive Vice President, Chief Financial Officer, Corporate Strategy

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