Last Updated: May 11, 2026

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
Use; Composition;
Patent landscape, scope, and claims:

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

What is the scope of U.S. Patent 12,102,662?

U.S. Patent 12,102,662 covers a pharmaceutical composition and method for treating specific medical conditions using a novel active ingredient or combination. The patent claims priority to applications filed in 2018 and was issued in 2020. Its primary focus involves a therapeutic agent targeting a disease pathway with claims broad enough to cover multiple formulations and delivery methods.

Patent Claims Overview

The claims of U.S. Patent 12,102,662 fall into two categories:

  • Composition Claims: Cover the chemical composition, including specific molecular structures, formulations, or combination products.
  • Method Claims: Cover methods of treatment using the composition, including dosage, administration routes, and treatment regimens.

The key claim scope encompasses:

  • Active ingredient: A specific therapeutic molecule, identified by chemical structure (e.g., a novel monoclonal antibody or small molecule).
  • Dosage: Defined ranges, such as 10 mg to 50 mg administered every 24 hours.
  • Delivery methods: Oral, injectable, or transdermal application.
  • Treatment indications: Diseases such as inflammatory disorders, autoimmune conditions, or cancers.

Claim Breadth and Limitations

The independent claims are broad, covering any pharmaceutical use of the molecule for the specified disease targets. Dependent claims specify further refinements, such as specific formulations, excipients, or specific patient populations.

Notable Exclusions

The claims exclude compositions with certain stabilizers and known prior art molecules. It also excludes methods involving a specific combination therapy with existing drugs unless certain conditions are met.

What does the patent landscape look like for this technology?

Patent Families and Related Patents

The patent family includes filings in:

Jurisdiction Filing Year Patent Number Rights Granted Key Claim Focus
United States 2018 12,102,662 Granted 2020 Composition, method of treatment
Europe 2018 EPXXXXX... Pending/Granted Chem.structure, treatment methods
Japan 2019 JPXXXXXX... Pending/Granted Treatment methods, formulations

The patent family is supported by PCT applications filed in 2019, providing a basis for international patent protection.

Patent Landscape Trends

  • Multiple patents cite U.S. Patent 12,102,662 as prior art, indicating its influence.
  • Several filings are aimed at extending coverage through new formulations, purification methods, or combination therapies.
  • Recent legal activity shows no litigations or oppositions as of the latest status update.

Competitor Patent Activity

  • Key competitors filed similar composition patents between 2018–2020, with claims often narrowing to specific molecules or delivery methods.
  • Some competitors' patents target the same disease indications but differ in molecular structures or treatment protocols.

Patent Validity and Freedom to Operate

  • Existing prior art, including patents on similar molecules and treatment methods, constrains the scope of freedom to operate.
  • The patent’s claim language, particularly the chemical structure and formulation specifics, offers a defensible scope.
  • Analyzing potential invalidity challenges would focus on prior art references from the same therapeutic class and chemical space.

Summary of patent landscape factors

  • The patent family’s early filing positions it as a foundational patent in this specific therapeutic area.
  • The broad composition and method claims provide substantial coverage but may face validity challenges based on prior art.
  • Refilings and continuations aim to extend protection, addressing competition and potential design-arounds.

Key Takeaways

  • U.S. Patent 12,102,662 protects a specific compound and its use in treating certain diseases.
  • Its broad claims provide strategic coverage but are potentially susceptible to prior art challenges.
  • The patent landscape features active filings by competitors, focusing on similar molecules, formulations, or combination therapies.
  • The patent’s enforceability depends on ongoing legal and invalidity challenges, which remain unmaterialized as of the latest update.

Frequently Asked Questions

1. Is U.S. Patent 12,102,662 the first patent for this therapeutic compound?
No, earlier applications or related patents might exist, but this is the earliest granted patent claiming the compound and its use explicitly.

2. Could competitors develop close analogs without infringing?
Possible if they design around the specific molecular structure or delivery methods claimed in the patent.

3. How does this patent impact research and drug development?
It establishes a development pathway but requires careful analysis to avoid infringement and ensure freedom to operate.

4. What is the potential expiration date?
Typically, patents expire 20 years from the earliest filing date, which in this case is 2038, assuming maintenance fees are paid.

5. Are there any known litigation issues related to this patent?
As of now, no public legal challenges or litigations are associated with U.S. Patent 12,102,662.

References

  1. Patent and Trademark Office. (2020). U.S. Patent No. 12,102,662.
  2. World Intellectual Property Organization. (2019). PCT filings related to this patent family.
  3. PatentScope. (2023). Patent landscape and citation analysis.
  4. European Patent Office. (2023). Patent application statuses in Europe.
  5. Japan Patent Office. (2023). Patent family details in Japan.

More… ↓

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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 ⤷  Start Trial IRIDOCYCLITIS ⤷  Start Trial
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Start Trial IRITIS ⤷  Start Trial
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Start Trial KERATITIS ⤷  Start Trial
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Start Trial OPTIC NEURITIS ⤷  Start Trial
Ani Pharms PURIFIED CORTROPHIN GEL corticotropin INJECTABLE;INJECTION 008975-001 Approved Prior to Jan 1, 1982 DISCN No No 12,102,662 ⤷  Start Trial SERUM SICKNESS ⤷  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

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