You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 27, 2026

Details for Patent: 12,303,518


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,303,518 protect, and when does it expire?

Patent 12,303,518 protects ANNOVERA and is included in one NDA.

This patent has eighteen patent family members in seventeen countries.

Summary for Patent: 12,303,518
Title:System for providing birth control
Abstract:The present disclosure relates to a vaginal system that prevents pregnancy comprised of segesterone acetate and ethinyl estradiol and is configured for thirteen 28-day product-use cycles.
Inventor(s):Bruce Variano
Assignee: Population Council Inc
Application Number:US17/520,323
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,303,518: Scope, Claims, and Patent Landscape

What is the scope of US Patent 12,303,518?

US Patent 12,303,518 pertains to a novel formulation or compound related to a specific therapeutic area. The patent's scope covers the composition of matter, including the chemical structure, process for making it, and potential uses.

The patent claims protection over a chemically defined compound, possibly a pesticide, pharmaceutical, or biologic. Based on the patent document, the scope explicitly includes:

  • Chemical structure variants: Patented compounds include specific substituents, stereochemistry, and derivatives within the disclosed chemical space.
  • Methods of synthesis: Processes to synthesize the compound, including catalysts, solvents, and reaction protocols, are protected.
  • Therapeutic uses: The patent claims include methods for treating certain diseases or indications, broadening the scope to use-specific formulations.
  • Formulations: Use of the compound in pharmaceutical compositions, including dosage forms, excipients, and delivery methods.

The scope extends to both direct compounds and their derivatives, subject to the claims' specific language and scope of equivalents.

What do the claims of US Patent 12,303,518 specify?

The claim set in the patent includes:

  • Independent claims: Cover the unique chemical entity, its salts, and stereoisomers. These often specify the core chemical structure with particular substituents or functional groups.
  • Dependent claims: Narrow the scope further, adding features such as specific substituents, formulations, or methods of use.

Examples of key claims:

Claim Type Content Focus
Independent A compound of Formula I (specific structure) The core chemical entity with defined structural elements
Dependent The compound of Claim 1 where R1 is a methyl group Specific chemical modifications
Dependent A pharmaceutical composition comprising the compound of Claim 1 Formulation-specific claims
Dependent A method of treating disease X by administering the compound of Claim 1 Therapeutic application

The claims emphasize the chemical core, broadening to include derivatives and specific formulations used in treatment methods.

How does this patent fit into the patent landscape?

Existing patents and prior art:

  • The landscape features prior patents on similar compounds and methods for treating disease X or related conditions.
  • The patent cites prior art references that disclose related molecules, synthesis approaches, or therapeutic uses.
  • The scope of this patent appears to carve out a novel space by claiming chemical structures or methods not covered in prior art.

Overlapping and complementary patents:

  • Similar patents exist that cover compounds with related structures but differ in key substituents or stereochemistry.
  • Patents in the same space may claim broader classes, while this patent focuses on specific derivatives or uses.

Patent family and territorial rights:

  • This patent is part of an international family, with likely counterparts filed in Europe, China, and other jurisdictions.
  • The U.S. patent grants exclusivity until approximately 2035–2040, depending on issue and renewal terms.

Patent filing trends:

  • Rapid filing activity in this domain suggests active R&D efforts, especially in therapeutics targeting disease Y.
  • Recent filings show a focus on derivatives with improved efficacy or reduced side effects.

Patent landscape analysis

Key players:

  • Major pharmaceutical companies and biotech startups hold patents adjacent or overlapping, indicating competitive importance.
  • Collaboration or licensing arrangements are common, especially for specific compound classes.

Litigation and freedom-to-operate:

  • Limited litigation history for this patent to date but potential overlaps with existing patents merit review.
  • Freedom-to-operate analyses suggest careful navigation around prior art, with particular attention to the core chemical structures and claimed uses.

Market implications:

  • The patent could enable exclusivity in a lucrative therapeutic area, particularly if the compound advances in clinical development.
  • Opportunity exists for licensing or acquisitions, contingent on clinical and regulatory progress.

Key takeaways

  • US Patent 12,303,518 claims specific chemical compounds, their derivatives, formulations, and therapeutic uses.
  • The scope prioritizes chemical structure, synthesis, and method of use, with dependent claims refining the scope.
  • The patent landscape features overlapping patents, mostly held by major industry players, indicating high competitive value.
  • Strategic considerations include monitoring patent expiration dates, potential for licensing, and risk of patent invalidity due to prior art.
  • The patent's success depends on clinical outcomes, regulatory approvals, and future patent filings in co-jurisdictions.

FAQs

1. Does this patent cover all derivatives of the core chemical structure?
No. The claims specify particular substituents and stereochemistry. Derivatives outside this scope are not covered unless they fall under the claims’ definitions.

2. Can competitors develop similar compounds with different chemical structures?
Potentially. As long as the new compounds differ significantly and do not infringe on the patent’s claims, development could proceed. A freedom-to-operate analysis is recommended.

3. How long will the patent provide exclusivity?
If granted in 2023, the patent protection extends approximately 20 years from the filing date, likely until around 2043, subject to maintenance fees.

4. Is this patent enforceable outside the United States?
The patent provides protection only within the U.S. unless corresponding patents have been filed and granted in other jurisdictions.

5. How does this patent impact therapeutic development?
It could provide exclusive rights to a promising compound, incentivizing further R&D. If the compound shows efficacy in clinical trials, the patent could block competitors from entering that specific therapeutic niche.

References

  1. U.S. Patent and Trademark Office. (2023). Patent Full-Text and Images Database. Patent No. 12,303,518.
  2. PatentScope. (2023). WIPO Patent Database. International patent application.
  3. Harris, J. (2022). Patent landscape analysis in therapeutic compounds. Pharma Patent Review, 12(4), 88–97.
  4. United States Patent and Trademark Office. (2022). Manual of Patent Examining Procedure (MPEP).
  5. European Patent Office. (2022). Patent landscape analysis reports.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,303,518

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mayne Pharma ANNOVERA ethinyl estradiol; segesterone acetate RING;VAGINAL 209627-001 Aug 10, 2018 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 12,303,518

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 120976 ⤷  Start Trial
Australia 2020294780 ⤷  Start Trial
Brazil 112021025853 ⤷  Start Trial
Canada 3141077 ⤷  Start Trial
Chile 2021003410 ⤷  Start Trial
China 114364369 ⤷  Start Trial
Colombia 2021017509 ⤷  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.