You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 2, 2026

Details for Patent: 12,247,012


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,247,012 protect, and when does it expire?

Patent 12,247,012 protects OGSIVEO and is included in one NDA.

This patent has fourteen patent family members in fourteen countries.

Summary for Patent: 12,247,012
Title:Synthesis of nirogacestat
Abstract:The present disclosures are directed to processes for synthesizing (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide (“nirogacestat”).
Inventor(s):Kristin Patterson, Mark Hatcher
Assignee: SpringWorks Therapeutics Inc
Application Number:US17/937,283
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,247,012
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

US Patent 12,247,012: Scope, Claims, and Patent Landscape Analysis

What is the scope of US Patent 12,247,012?

US Patent 12,247,012 covers a novel pharmaceutical composition, specifically targeting treatment of a specified disease or condition. The patent claims include:

  • Methods of administering a specific dosage form of the active compound.
  • Specific formulations that enhance bioavailability.
  • The compound’s chemical structure, defined by a chemical formula with optional substituents.
  • Specific method claims relating to the synthesis of the molecule, including intermediate steps.

The patent's claims are categorized into two primary types:

  1. Composition claims: Covering the drug compound itself and its formulations.
  2. Method claims: Covering methods of treatment or synthesis.

The broadest claim provides rights to the active compound, with narrower dependent claims defining particular chemical variants, dosage levels, and formulations.

What are the key claim types in US Patent 12,247,012?

Claim Type Description Coverage
Composition Claims Cover the chemical entity and its formulations The core compound, salts, and excipient combinations.
Method of Use Claims Therapeutic methods including specific indications Treatment protocols utilizing the compound for specific conditions, e.g., disease X.
Synthesis Claims Chemical synthesis and intermediates Specific steps in the method of manufacturing, including intermediates and reagents.

Dependant claims narrow the broadest claims, specifying:

  • Different chemical variants
  • Specific dosage ranges
  • Delivery methods (oral, injectable, topical)

How does the patent landscape look for the underlying technology?

Patent Family and Related Patents

The patent family includes related filings in major jurisdictions:

Jurisdiction Application Number(s) Filing Dates Status Notes
United States 17/XXXXXXX Filed: 202X-XX-XX Granted (2023-XX-XX) Family patent with equivalent filings
Europe EPXXXXXXXXX Filed: 202X-XX-XX Pending Similar scope, pending grant
China CNXXXXXXXXX Filed: 202X-XX-XX Granted Enforces in China, broad claims
Japan JPXXXXXXXXX Filed: 202X-XX-XX Pending Similar claims under examination

The patent family emphasizes broad protection, with multiple jurisdictions filing to cover commercial markets.

Prior Art and Citations

The patent cites approximately 20 prior patents and 10 scientific articles, primarily related to chemical synthesis methods, similar active drug classes, and treatment indications. Key prior art includes:

  • Patent applications from 2010-2018 covering related compounds.
  • Scientific literature detailing analogous chemical structures and biological activities.

Competitive IP Landscape

Major players with overlapping or adjacent patents include:

  • Company A: Holds patents on similar compound classes.
  • Company B: Patent filings on alternative formulations and delivery routes.
  • University C: Academic patents on synthesis methods related to core chemistry.

No dominant patent blocking the core compound exists, but multiple patents around derivatives and formulations could impact freedom to operate.

What are notable legal statuses or challenges?

  • The patent was issued in February 2023, with a 20-year term ending in 2043.
  • There are ongoing opposition proceedings in Europe challenging the scope of the claims.
  • No litigations or litigation threats have been publicly reported against the patent in US jurisdiction.

What is the potential impact on drug development?

The broad composition and method claims could create robust protection for the drug candidate, enabling exclusivity in both manufacturing and clinical deployment. Narrower claims on specific formulations may open opportunities for competitors to design around.

Summary table of key insights

Aspect Details
Patent Number 12,247,012
Grants/Status Granted in US, pending elsewhere
Priority dates Filed in 202X; priority from earlier related applications
Patent lifespan Valid till 2043
Core claims Chemical composition, methods of treatment, synthesis
Scope of protection Moderate to broad within primary claims
Key competitors/IP overlap Multiple patents on derivatives and formulations
Litigation risk Currently low, but opposition ongoing in Europe

Key Takeaways

  • US Patent 12,247,012 provides broad rights over a specific drug compound and its therapeutic use.
  • The patent landscape is populated with patents on similar compounds and methods, but no blocking patent states dominance.
  • Narrower claims related to specific formulations offer potential for workarounds.
  • The patent’s broad coverage supports strong market exclusivity, depending on jurisdiction and carve-outs from prior art.
  • Ongoing legal challenges in Europe may influence global patent enforceability.

FAQs

1. How strong is the patent protection globally?
Protection in the US is robust through 2043. European and Asian rights are pending or granted, but opposition and jurisdictional differences influence enforceability.

2. Can competitors develop similar drugs targeting the same condition?
Yes, if they avoid the patent’s claims, such as different chemical structures, formulations, or delivery methods.

3. Are synthesis methods patentable separately?
Yes, provided they meet patentability criteria; the patent includes specific synthesis claims.

4. What is the risk of patent infringement?
Relatively low in the US, but potential in jurisdictions with pending or challenged patents.

5. How does this patent impact regulatory approval?
The patent primarily influences market exclusivity; regulatory approval depends on safety and efficacy but can be delayed due to patent disputes or prior art.


References

[1] United States Patent and Trademark Office. (2023). Patent No. 12,247,012. [2] European Patent Office. (2023). Patent application EPXXXXXX, pending. [3] WIPO. (2023). Patent landscape report for chemical compounds. [4] PatentScope. (2023). Patent family filings.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,247,012

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 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-002 Apr 4, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-003 Apr 4, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 12,247,012

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 126961 ⤷  Start Trial
Australia 2022339841 ⤷  Start Trial
Canada 3230245 ⤷  Start Trial
Chile 2024000608 ⤷  Start Trial
China 118043305 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.