Details for Patent: 11,925,619

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Which drugs does patent 11,925,619 protect, and when does it expire?

Patent 11,925,619 protects OGSIVEO and is included in one NDA.

This patent has eighty patent family members in twenty-nine countries.

Summary for Patent: 11,925,619

Title:	Treatments with nirogacestat
Abstract:	The present disclosure relates to improved methods of treatment with nirogacestat.
Inventor(s):	Allison Lim, Shinta CHENG, Todd Webster SHEARER, Rex WILLIAMS, Kristin Patterson
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US18/361,884
Patent Claim Types: see list of patent claims	Use; Dosage form;

United States Patent 11,925,619: Nirogacestat Patent Scope, Claims, Expiration and Generic Risk

U.S. Patent No. 11,925,619 protects a treatment protocol for desmoid tumors using nirogacestat at 150 mg twice daily, together with pharmacokinetic exposure limits and mandatory dose management for liver-enzyme elevations. The patent does not broadly claim nirogacestat, gamma-secretase inhibition, or every use of nirogacestat. Its commercial significance is narrower but substantial: the claimed regimen tracks the FDA-approved OGSIVEO dosing and hepatotoxicity-management instructions.

The patent was issued to SpringWorks Therapeutics on March 12, 2024. Its nominal patent expiration is in December 2035, subject to any patent-term adjustment or extension reflected in the official USPTO record. OGSIVEO received FDA approval on November 27, 2023, for adults with progressing desmoid tumors who require systemic treatment.[1][2]

What does U.S. Patent 11,925,619 protect?

The patent protects two related method-of-treatment claim sets:

Claim group	Required pharmacokinetic limitation	Required starting regimen	Liver-management limitation
Claims 1-7 and 15	Initial Cmax below 1,000 ng/mL	150 mg free-base equivalent twice daily	Withhold at ALT or AST 3-5× ULN; restart at 100 mg twice daily after resolution; permanently discontinue above 5× ULN under claims 15 and 16
Claims 8-14 and 16	Initial AUCinf below 4,000 ng·h/mL	150 mg free-base equivalent twice daily	Same withholding, reduced-dose restart and permanent-discontinuation framework

The patent therefore combines four elements:

1. Treatment of a patient with desmoid tumor.
2. Oral administration of nirogacestat or a pharmaceutically acceptable salt.
3. A specified initial pharmacokinetic exposure threshold.
4. A defined dose-modification protocol based on ALT and AST laboratory results.

The claims are method claims, not composition claims. They do not independently protect the chemical structure of nirogacestat, a tablet composition, a manufacturing process, or a salt form.

How broad are the independent claims?

Claims 1 and 8 are the principal enforceable claims. Their scope is narrower than the FDA indication but closely aligned with the approved regimen.

Claim 1: Cmax-based protection

Claim 1 requires that the initial oral dose produce a maximum plasma concentration below 1,000 ng/mL. It also requires administration of 150 mg twice daily and specifies the response to ALT or AST elevations of 3-5 times the upper limit of normal.

The claim is not limited to progressive desmoid tumors because progression is added only in dependent claim 4. It potentially covers:

• Adults or other patients, unless the specification or prosecution history imposes a narrower construction.
• Any desmoid tumor patient meeting the dosing and pharmacokinetic limitations.
• Nirogacestat free base or a pharmaceutically acceptable salt.
• Treatment protocols that use the claimed dose reductions after liver-enzyme elevations.

Claim 8: AUC-based protection

Claim 8 substitutes an AUCinf threshold below 4,000 ng·h/mL for the Cmax requirement. This creates a separate exposure-based infringement route.

A product could theoretically satisfy one threshold but not the other. Claims 1 and 8 should therefore be analyzed independently in a generic or biosimilar-risk assessment.

Conditional liver-management language

The phrase requiring withholding treatment when ALT or AST reaches 3-5× ULN is a conditional method step. A patient who never develops the specified laboratory abnormality may raise a question about whether the conditional step is required for infringement. The stronger infringement case arises when the prescribing information, treatment protocol or clinical practice expressly directs the claimed withholding and 100 mg twice-daily restart.

Claims 15 and 16 separately address ALT or AST greater than 5× ULN and require permanent discontinuation. These claims are narrower because they add an additional adverse-event scenario.

What are the dependent claims worth commercially?

Claims 2 and 9 state that the oral dosage is administered once daily. Claims 3 and 10 state twice-daily administration. Because the independent claims already require a 150 mg twice-daily regimen, the once-daily dependent claims create an apparent internal tension.

The likely legal issue is claim construction. A court could read the dependent claim as adding a once-daily administration limitation to a claim that already requires a twice-daily 150 mg regimen. That creates an inconsistency rather than a clear, commercially useful once-daily coverage position. The twice-daily dependent claims are more internally consistent and closely track the approved OGSIVEO regimen.

Claims 4 and 11 narrow the indication to progressive desmoid tumor. Claims 5-7 and 12-14 recite clinical outcomes, including:

• Reduced risk of disease progression.
• Improved progression-free survival.
• Improved objective response rate.
• Improvement in at least one quality-of-life assessment.

These outcome limitations may provide fallback positions, but they do not necessarily create separate practical treatment categories. If the outcomes are inherent results of the claimed regimen, they may not materially narrow infringement. Their value will depend on claim construction, prosecution history and whether the outcomes are treated as limiting method steps.

When does U.S. Patent 11,925,619 expire?

Event	Date or status
FDA approval of OGSIVEO	November 27, 2023
Patent issuance	March 12, 2024
Nominal patent expiration	December 2035, reported as December 18, 2035
Patent-term adjustment	Must be confirmed from the USPTO patent record
Pediatric exclusivity	No separate pediatric extension is identified in the supplied record
Regulatory exclusivity	OGSIVEO received orphan-drug exclusivity for the approved desmoid-tumor indication

The patent’s practical barrier extends beyond its issuance date because a generic applicant must address both patent certification requirements and FDA exclusivity. Orphan-drug exclusivity generally runs for seven years from approval for the protected indication, subject to statutory exceptions.[1][3]

A patent-term-extension analysis should distinguish:

• Patent expiration under 35 U.S.C. § 154.
• Any patent-term adjustment for USPTO examination delay.
• Potential patent-term extension under 35 U.S.C. § 156.
• FDA orphan-drug exclusivity.
• Any later-issued continuation or divisional patents.

The controlling expiration date is the date shown in the USPTO Patent Center record and current FDA Orange Book data.[2][4]

What is the Orange Book status of U.S. Patent 11,925,619?

U.S. Patent 11,925,619 is associated with OGSIVEO and is directed to the approved desmoid-tumor treatment regimen. The relevant Orange Book analysis is a method-of-use listing analysis, not a composition-patent analysis.

A listed method-of-use patent can affect an ANDA through a Paragraph IV certification. The generic applicant may attempt:

• A Paragraph III certification, deferring approval until patent expiration.
• A Paragraph IV certification, asserting that the patent is invalid, unenforceable or not infringed.
• A section viii statement carving out a patented method, if the remaining label does not encourage the patented use.

A section viii strategy is difficult where the patent covers the only FDA-approved indication for the reference product and the proposed generic label necessarily describes the same dosing regimen. The generic applicant would face additional risk if the label includes the 150 mg twice-daily dose and the same liver-test management instructions.

What generic-entry risks exist for OGSIVEO?

The leading generic-entry scenarios are as follows:

Scenario	Commercial effect
No Paragraph IV challenge	Approval likely delayed until patent and regulatory exclusivity barriers expire
Paragraph IV challenge without litigation	FDA approval may proceed after the statutory notice period, subject to other barriers
Paragraph IV challenge followed by litigation	A 30-month stay may delay approval, unless litigation is resolved earlier
Section viii carve-out	Potentially available only if the remaining label avoids the patented regimen and indication
At-risk launch after litigation or stay expiration	Exposure to damages, injunction risk and induced-infringement claims
Post-2035 entry	Main patent barrier removed, subject to other listed patents or continuations

The patent creates an important induced-infringement issue. A generic manufacturer may argue that it sells only tablets and does not administer them to patients. SpringWorks could respond that the proposed label, dosing instructions and safety-management language encourage physicians and patients to perform the patented method.

The pharmacokinetic limitations create a second dispute. A generic applicant may challenge whether the proposed product necessarily produces a Cmax below 1,000 ng/mL or AUCinf below 4,000 ng·h/mL in the relevant patient population. SpringWorks would likely rely on clinical pharmacology data, product equivalence, formulation similarity and the reference-product label.

Does the patent cover nirogacestat formulations?

No. The claims provided do not require a specific tablet formulation, excipient system, release profile, coating, polymorph or manufacturing process.

The patent reaches a formulation indirectly when the formulation delivers the claimed pharmacokinetic exposure. A different tablet composition could still fall within claims 1 or 8 if it is used at the claimed dose and produces the specified Cmax or AUCinf.

A generic formulation could attempt to avoid the patent by demonstrating that:

• Its formulation does not produce the claimed exposure.
• Its proposed label excludes the patented treatment protocol.
• Its dosing regimen differs from 150 mg twice daily.
• Its product is not intended for the patented desmoid-tumor use.

Those strategies would have to account for FDA bioequivalence requirements. A product that is bioequivalent to OGSIVEO may have difficulty avoiding the same exposure limitations.

What are the method-of-use patent risks?

The patent is strongest as a regimen patent. Its key limitations are operational instructions that are likely to appear in clinical practice:

• 150 mg orally twice daily as the initial dose.
• Dose interruption for ALT or AST elevations of 3-5× ULN.
• Restart at 100 mg twice daily after recovery.
• Permanent discontinuation for ALT or AST greater than 5× ULN.

The patent is weaker against treatment protocols that materially depart from those instructions. Examples include:

• A different starting dose.
• A non-oral route.
• A dosing frequency that cannot be reconciled with the claim language.
• A treatment indication outside desmoid tumors.
• A protocol that does not use the claimed liver-management steps.

The Cmax and AUC limitations may also create proof burdens. Exposure varies with patient characteristics, food, concomitant medicines and testing conditions. A patent owner generally must establish that the accused method satisfies the numerical limitation, either expressly or inherently.

How does the patent compare with composition and manufacturing patents?

Patent category	Present in the supplied claims?	Generic risk
Nirogacestat chemical composition	No	Depends on separate composition patents
Pharmaceutically acceptable salt	Included as an alternative to nirogacestat	Does not independently claim a salt composition
Tablet formulation	No	Depends on separate formulation patents
Manufacturing process	No	Depends on process patents and trade secrets
Desmoid-tumor treatment method	Yes	Core protection of U.S. Patent 11,925,619
Pharmacokinetic exposure	Yes	Cmax and AUC-based infringement issues
Hepatotoxicity dose management	Yes	Links the patent to the FDA label
Progressive desmoid tumor	Yes, in dependent claims	Narrower indication-specific protection

The patent should not be treated as the entire nirogacestat estate. A complete freedom-to-operate review must include issued patents, pending continuations, Orange Book listings, patent-term adjustments, licensing rights and foreign counterparts.

Which company owns and commercializes nirogacestat?

SpringWorks Therapeutics commercializes OGSIVEO. Pfizer originally developed nirogacestat, also known as PF-03084014, and licensed rights to SpringWorks in 2017. The transaction gave SpringWorks rights to develop and commercialize nirogacestat for multiple potential indications, including desmoid tumors.[5]

The ownership chain matters because patent enforcement rights may depend on assignment records, exclusive-license provisions and the right to sue. The USPTO assignment database and patent front page should be checked for the operative assignee and any recorded security interests.

What is the competitive landscape for desmoid-tumor treatment?

OGSIVEO is the first FDA-approved systemic treatment specifically authorized for adults with progressing desmoid tumors. The competitive environment includes:

• Sorafenib, used off label.
• Cytotoxic chemotherapy combinations.
• Tyrosine kinase inhibitors.
• Local surgery or radiotherapy in selected cases.
• Active surveillance for stable, asymptomatic disease.
• Investigational gamma-secretase inhibitors and other targeted therapies.

FDA approval was based on the DeFi study, which showed a progression-free-survival benefit and objective responses in adults with progressing desmoid tumors.[1][6]

The narrow patient population limits absolute volume but supports premium pricing and high exposure per treated patient. Patent erosion would affect the full approved indication because OGSIVEO does not have a broad multi-indication label comparable to larger oncology products.

Is there biosimilar risk for nirogacestat?

There is no conventional biosimilar pathway risk. Nirogacestat is a small-molecule drug, not a biologic. A competing manufacturer would normally pursue an ANDA or, in some circumstances, an NDA under section 505(b)(2), rather than a biosimilar application under the Public Health Service Act.

The more relevant risks are:

• ANDA Paragraph IV litigation.
• 505(b)(2) applications relying on published clinical data.
• Competing small-molecule products with different labels.
• Off-label use of alternative desmoid-tumor therapies.
• New molecular treatments that reduce OGSIVEO demand without directly infringing the patent.

What patent litigation or settlement activity affects OGSIVEO?

The supplied record identifies no litigation, settlement or Paragraph IV resolution involving U.S. Patent 11,925,619. Because the patent issued after OGSIVEO approval, future litigation risk will depend on the timing and content of ANDA filings.

A Paragraph IV notice would be the principal trigger for patent litigation. A settlement could include a delayed generic-entry date, a license, a supply arrangement or restrictions on the generic label. No settlement terms should be inferred without a filed court agreement or public SEC disclosure.

Key Takeaways

• U.S. Patent 11,925,619 is a method-of-treatment patent for nirogacestat in desmoid tumors.
• Its core protection tracks the OGSIVEO regimen: 150 mg orally twice daily.
• Claims 1 and 8 use separate Cmax and AUCinf exposure thresholds.
• The patent also claims liver-enzyme dose interruption, reduced-dose restart and permanent discontinuation.
• The reported nominal expiration is December 18, 2035, subject to USPTO-confirmed term adjustment.
• The patent does not claim nirogacestat’s chemical structure, a tablet formulation or a manufacturing process.
• Generic risk is highest for a product using the same 150 mg twice-daily label and the same desmoid-tumor indication.
• The patent is not a biosimilar issue because nirogacestat is a small molecule.
• Orphan-drug exclusivity and any additional Orange Book patents must be evaluated separately from this patent.
• The once-daily dependent claims contain an apparent inconsistency with the twice-daily limitation in the independent claims.

FAQs

Can a generic manufacturer avoid U.S. Patent 11,925,619 by using a different nirogacestat salt?

Not necessarily. The claims expressly cover nirogacestat and pharmaceutically acceptable salts. A different salt may avoid the patent only if it does not satisfy another claim element or is outside the claim’s construction.

Does a patient’s actual Cmax need to be below 1,000 ng/mL for claim 1 infringement?

The claim contains that numerical limitation. Infringement would generally require proof that the accused treatment produces the claimed exposure, either directly or inherently under the applicable legal standard.

Does the patent cover every patient treated with OGSIVEO?

No. The claims require the specified oral regimen, pharmacokinetic exposure and liver-management conditions. Patients treated under materially different protocols may fall outside the claims.

Can an ANDA applicant omit the desmoid-tumor indication?

A label carve-out may be considered only if the remaining label does not encourage the patented use. Because desmoid tumor is the approved OGSIVEO indication, omitting it could undermine the commercial value of the ANDA.

Is U.S. Patent 11,925,619 the last possible U.S. patent barrier for nirogacestat?

Not necessarily. Continuations, formulation patents, composition patents, manufacturing patents or later-issued method patents could create additional barriers. The Orange Book and USPTO records must be reviewed as of the proposed launch date.

References

1. U.S. Food and Drug Administration. (2023). Ogsiveo (nirogacestat) prescribing information. FDA.

2. United States Patent and Trademark Office. (2024). U.S. Patent No. 11,925,619, methods for treating desmoid tumors. USPTO Patent Center.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

4. United States Patent and Trademark Office. (2024). Patent term adjustment and patent assignment records for U.S. Patent No. 11,925,619. USPTO.

5. SpringWorks Therapeutics, Inc. (2017). SpringWorks enters into exclusive global license agreement with Pfizer for nirogacestat. Company announcement.

6. Gounder, M., Ratan, R., Alcindor, T., Schöffski, P., van der Graaf, W. T. A., Wilky, B. A., et al. (2023). Nirogacestat, a gamma-secretase inhibitor for desmoid tumors. New England Journal of Medicine, 388, 898-912.

Drugs Protected by US Patent 11,925,619

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-001	Nov 27, 2023		DISCN	Yes	No	11,925,619					TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-002	Apr 4, 2024		RX	Yes	No	11,925,619					TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS
Springworks	OGSIVEO	nirogacestat hydrobromide	TABLET;ORAL	217677-003	Apr 4, 2024		RX	Yes	Yes	11,925,619					TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS

International Family Members for US Patent 11,925,619

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	4010322		CA 2026 00017	Denmark
European Patent Office	4010322		301374	Netherlands
European Patent Office	4010322		C20260011	Finland
European Patent Office	4010322		LUC50046	Luxembourg
European Patent Office	4010322		PA2026516	Lithuania
European Patent Office	4010322		122026000026	Germany