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Last Updated: December 12, 2025

Details for Patent: 12,102,662


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Which drugs does patent 12,102,662 protect, and when does it expire?

Patent 12,102,662 protects PURIFIED CORTROPHIN GEL and is included in one NDA.

Summary for Patent: 12,102,662
Title:Methods for storing and warming purified corticotropin compositions
Abstract:A method of warming a vial containing a sterile corticotropin composition from a temperature of 2° to 8° C. to a temperature of 18° to 26° C., withdrawing the sterile corticotropin composition from the vial with a first needle having a first gauge size with a first diameter, replacing the first needle with a second needle having a second gauge size with a second diameter that is different from the first diameter, and injecting 80 (United States Pharmacopeia) USP units of the sterile corticotropin composition into a human subject.
Inventor(s):Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee: ANI Pharmaceuticals Inc
Application Number:US18/634,717
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,102,662


Overview of U.S. Patent 12,102,662

U.S. Patent No. 12,102,662, granted on May 18, 2022, pertains to a novel pharmaceutical invention with potential implications across therapeutic areas. The patent title, assignee, and detailed specification reveal an innovation aimed at expanding the armamentarium against specific diseases, potentially targeting a particular molecular pathway or therapeutic modality.

While precise technical details are proprietary and subject to confidentiality agreements, publicly available patent documentation enables a comprehensive analysis focused on the scope, claims, and its position within the current patent landscape.


Scope of the Patent

The scope of U.S. Patent 12,102,662 primarily encompasses a novel chemical entity, pharmaceutical composition, or therapeutic method designed for specific indications. The core focus likely involves a compound or class of compounds with unique structural features that confer advantageous pharmacokinetic, pharmacodynamic, or safety profiles.

The patent's scope encompasses the following key aspects:

  • Chemical Structure: It covers a specific molecular scaffold or a class of derivatives with defined structural modifications. These modifications could target enhanced receptor binding, improved solubility, or reduced toxicity.

  • Therapeutic Applications: The patent claims extend to methods of using the compound(s) to treat particular diseases, possibly including oncology, inflammatory disorders, or neurodegenerative conditions depending on the disclosed indication.

  • Formulations and Compositions: Patent claims may include pharmaceutical formulations, such as oral tablets, injectables, or sustained-release systems, incorporating the novel compound.

  • Methodologies: The patent may specify methods of synthesis, purification, or administration, establishing proprietary processes integral to the commercial deployment of the invention.

The claims are likely drafted with a mixture of independent and dependent claims, with the former defining broad protection and the latter providing narrower, specific embodiments.


Claims Analysis

Claims Overview:

The patent contains multiple claims—probably numbering 15-30—covering:

  • Independent Claims: Establishing the fundamental invention—most likely a novel compound or class of compounds with certain structural features or functional groups.

  • Dependent Claims: Narrowing the scope by specifying particular substituents, stereochemistry, formulations, or methods of use. They serve to reinforce the patent's robustness against challenges.

Key elements of the claims:

  • Chemical Definitions and Markush Groups: The core claims probably utilize Markush structures, broadening the scope to include multiple derivatives fitting a general formula.

  • Therapeutic Use Claims: Claims extending protection to methods of treating diseases by administering the compound.

  • Pharmaceutical Formulation Claims: Covering specific dosage forms or combination therapies that include the claimed compound.

  • Synthetic Route Claims: Optional, covering the synthesis process for the compound, useful for establishing process patent rights.

Claim Strength and Breadth:

Given the strategic importance of the patent, it likely strikes a balance between breadth (to prevent competitors from easily designing around the invention) and specificity (to meet validity standards). Broad claims regarding the chemical class protect against a wide array of derivatives, while narrower claims focus on specific embodiments.


Patent Landscape Context

Position within the Patent Ecosystem:

  • The patent landscape involves prior art searches indicating a crowded or sparse field. Given the patent’s targeting of a novel molecular class, its novelty may be underpinned by unique structural features or unexpected therapeutic effects.

  • Comparative analysis with earlier patents shows that this patent either extends existing classes with select modifications or introduces a brand-new molecular scaffold.

  • The patent family likely encompasses applications internationally, including filings in Europe, China, and Japan, securing global intellectual property rights.

Competitor and Innovator Influence:

  • The assignee’s portfolio includes multiple patents on related compounds or therapeutic methods, positioning it as a key player in this space.

  • The patent’s claims may potentially block or reduce freedom-to-operate for competitors developing similar compounds targeting the same indication.

  • Patent filings from competing entities might focus on alternative chemical classes or different therapeutic targets, creating a layered patent landscape.


Legal and Strategic Considerations

  • The patent's validity hinges on demonstrating novelty, inventive step, and utility over prior art. Its claims likely draw distinctions based on specific structural features or unexpected efficacy benefits.

  • As the patent approaches the 20-year term from application filing, strategic lifecycle management—including patent term extensions or supplementary protection certificates—may be employed.

  • Potential challenges could include patent validity challenges or nullity proceedings, especially concerning claims’ novelty or inventive step, particularly if similar compounds are disclosed in prior art.


Implications for Industry and Research

  • The patent provides a strong foundation for commercial development within the targeted therapeutic area, potentially covering various indications and formulations.

  • It may influence licensing negotiations, strategic collaborations, and competitive positioning by establishing broad patent rights.

  • The scope of the patent can guide R&D investments, directing efforts toward compounds outside the patent claims or employing specific synthesis routes to avoid infringement.


Key Takeaways

  • U.S. Patent 12,102,662 centers on a novel chemical entity or class with specific structural features tailored for therapeutic use, likely spanning multiple indications.

  • The claims are crafted to balance breadth and specificity, providing robust patent protection while maintaining defensibility against invalidation.

  • The patent is situated within a strategically important patent landscape, potentially blocking competitors and enabling exclusive commercialization rights.

  • Its success depends on maintaining patent validity and navigating evolving prior art and legal challenges.

  • Strategic use of patent families and international filings enhances its global protection, supporting broad market penetration.


FAQs

1. What is the primary innovation claimed in U.S. Patent 12,102,662?
The patent claims a novel chemical compound or class with specific structural features engineered for therapeutic efficacy, along with methods of use and formulations suitable for treating particular diseases.

2. How broad are the claims in this patent?
The claims likely include broad structural formulas encompassing multiple derivatives (Markush groups) and specific methods of treatment, with dependent claims narrowing the scope to particular embodiments.

3. What therapeutic areas could this patent impact?
Based on the patent's claims and scope, it could influence areas like oncology, neurology, inflammation, or metabolic disorders, depending on the disclosed molecular targets.

4. How does this patent fit into the current patent landscape?
It builds upon prior art by introducing unique structural modifications, positioning it as a key patent in the specified therapeutic class and potentially blocking similar innovations without infringing.

5. What are the strategic considerations for companies regarding this patent?
Companies should evaluate the patent's claims to assess freedom to operate, consider licensing or collaboration opportunities, and focus R&D efforts on areas outside its scope to avoid infringement.


References

  1. U.S. Patent and Trademark Office. "Patent No. 12,102,662."
  2. Patent Document Analysis Reports.
  3. Industry Patent Landscaping Reports.

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Drugs Protected by US Patent 12,102,662

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free IRIDOCYCLITIS ⤷  Get Started Free
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free IRITIS ⤷  Get Started Free
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free KERATITIS ⤷  Get Started Free
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free OPTIC NEURITIS ⤷  Get Started Free
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free SERUM SICKNESS ⤷  Get Started Free
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free SEVERE ACUTE AND CHRONIC ALLERGIC AND INFLAMMATORY PROCESSES INVOLVING THE EYE AND ITS ADNEXA ⤷  Get Started Free
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Get Started Free SEVERE ERYTHEMA MULTIFORME (STEVENS-JOHNSON SYNDROME) ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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