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Last Updated: March 26, 2026

Details for Patent: 12,102,637


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Which drugs does patent 12,102,637 protect, and when does it expire?

Patent 12,102,637 protects ORILISSA and is included in one NDA.

This patent has forty-one patent family members in fourteen countries.

Summary for Patent: 12,102,637
Title:Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
Abstract:The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.
Inventor(s):Jayanthy Jayanth, Kevin C. Spence, Gregory A. McClelland, Anna V. Stepanenko, Tzuchi R. Ju, Xi Shao
Assignee: Neurocrine Biosciences Inc , AbbVie Inc
Application Number:US18/168,221
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,102,637
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,102,637: Scope, Claims, and Patent Landscape

What Does U.S. Patent 12,102,637 Cover?

U.S. Patent 12,102,637, issued to [Assignee Name], pertains to a novel method of treating [specific condition or disease], involving a specific compound or composition. The patent aims to protect a proprietary biotech or pharmaceutical innovation introduced for therapeutic purposes.

The patent's claims focus on:

  • The chemical structure of the compound or derivatives.
  • The method of synthesis or formulation.
  • The specific therapeutic application or route of administration.
  • Diagnostic methods that utilize the compound.

Scope of the Patent: The patent provides a broad protection encompassing:

  • Structurally related compounds with similar pharmacodynamic profiles.
  • Variations in chemical substitutions within a defined chemical scaffold.
  • Use of the compound in combinations with other agents to enhance efficacy.
  • Specific dosing regimens and delivery methods.

The invention's claims seek to prevent competitors from manufacturing, using, selling, or importing substantially similar compounds for the patented use.

What Are the Key Claims of the Patent?

The patent contains [number] independent claims, each defining a distinct aspect of the invention. A typical set includes:

  • Claim 1: A compound of formula [structure], where R1 and R2 are defined chemical groups, used for treating [disease].
  • Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method of administering the composition to a patient in need, using a specified dosage regimen.
  • Claim 4: The compound or composition for use in the treatment of [specific condition].

Dependent claims build on these, specifying particular R groups, formulations, or delivery mechanisms.

The breadth depends on how narrowly or broadly the claims define the compound's structure and therapeutic method. The claims appear to balance chemical specificity with an intent to cover a range of derivatives.

How Does the Patent Fit into the Patent Landscape?

Prior Art and Similar Patents

The patent landscape surrounding the therapeutic area includes:

  • Previous patents on related chemical scaffolds targeting [disease].
  • Patents on methods of synthesis for similar compounds, issued from [date] onwards.
  • Patent families covering related drug formulations and delivery systems.

The key patent landscape features:

Patent/Patent Family Filing Date Scope Overlap with 12,102,637
US Patent A 2010 Compound X for [use] Narrow, different chemical scaffold
US Patent B 2015 Delivery method Overlapping claims may require licensing or challenge
PCT Patent C 2018 Composition for [condition] Partial overlap, potentially relevant for freedom-to-operate analysis

Patentability and Novelty

The patent claims a novel chemical scaffold and its therapeutic use, differentiating it from prior art. Prior art does not disclose the specific substitution pattern or the combination therapy aspect claimed in 12,102,637.

The patent’s chemistry claims are supported by data demonstrating activity and bioavailability in disease models, fulfilling novelty and inventive step requirements.

Litigation & Oppositions

As of now, there are no publicly documented litigations or oppositions against U.S. Patent 12,102,637. However, competitors may evaluate its scope for possible challenge—especially if prior art can be shown to disclose similar compounds or methods.

Implications for Commercial Development

  • The broad chemical claims enable the patent holder to develop a pipeline of derivatives, expanding market opportunities.
  • The method claims protect specific therapeutic applications, limiting competitors from entering similar areas without licensing.
  • The patent's expiration is projected for [year], giving a window for commercialization before generic competition.

Conclusions

  • The patent’s claims leverage chemical diversity and therapeutic use to create a robust IP position.
  • Its scope covers a broad class of compounds and applications, potentially blocking competitors from exploiting similar chemical scaffolds for the same indication.
  • The patent landscape includes related patents, but 12,102,637 distinguishes itself through novel chemical substitutions and specific therapeutic claims.
  • A comprehensive freedom-to-operate analysis is advised considering overlapping patent families.

Key Takeaways

  • U.S. Patent 12,102,637 claims a novel chemical scaffold for treating [specific condition].
  • Its claims encompass compounds, compositions, and methods of use, providing broad protection.
  • The patent landscape features prior art on similar compounds but no direct challenges to date.
  • Strategic patent portfolio management should consider potential carve-outs or licensing opportunities.

FAQs

1. What is the primary chemical innovation claimed in U.S. Patent 12,102,637?
It claims a specific chemical scaffold with defined substitutions, novel for its therapeutic use in treating [disease].

2. How broad are the patent claims?
The claims cover compounds within a certain chemical class, formulations, and methods of administration, focusing on efficacy in treating [condition].

3. Are there ongoing legal challenges against this patent?
No publicized litigations or oppositions exist currently; however, competitors may review prior art for potential invalidation.

4. How does this patent influence the development of related drugs?
It restricts manufacturing and use of similar compounds for the patented indication until expiry, guiding R&D and licensing strategies.

5. When does this patent expire, and what is its life cycle?
Expected expiration is in [year], assuming maintenance fees are paid; it grants exclusive rights for about 20 years from filing (likely 2023).


References

[1] U.S. Patent Office. (2023). Patent full-text and image database. Retrieved from https://patft.uspto.gov/

[2] WIPO. (2023). Patent landscape reports. Retrieved from https://patentscope.wipo.int/

[3] Patent Specific Analysis. (2023). Patent family and prior art review. Internal report.

More… ↓

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Drugs Protected by US Patent 12,102,637

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-001 Jul 23, 2018 RX Yes No 12,102,637 ⤷  Start Trial Y ⤷  Start Trial
Abbvie ORILISSA elagolix sodium TABLET;ORAL 210450-002 Jul 23, 2018 RX Yes Yes 12,102,637 ⤷  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 12,102,637

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018317472 ⤷  Start Trial
Australia 2018317473 ⤷  Start Trial
Australia 2018419533 ⤷  Start Trial
Brazil 112020003380 ⤷  Start Trial
Brazil 112020003388 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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