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Last Updated: March 26, 2026

Details for Patent: 11,246,991


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Which drugs does patent 11,246,991 protect, and when does it expire?

Patent 11,246,991 protects BYNFEZIA PEN and is included in one NDA.

Summary for Patent: 11,246,991
Title:Method of injecting octreotide acetate into the body
Abstract:A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 μg/mL. The method further includes providing, on the injector, a plurality of indicia only at prescribed doses of 50 μg, 100 μg, 150 μg and 200 μg settable via the dose setter without indicia between said prescribed doses; and permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter, wherein the injector is configured to provide at least one audible feedback during the rotation.
Inventor(s):Satyashodhan Babasaheb Patil, Sudeep Kumar Agrawal, Subhas Balaram Bhowmick, Prashant Kane
Assignee: Sun Pharmaceutical Industries Ltd
Application Number:US17/363,325
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 11,246,991

What does Patent 11,246,991 cover in scope?

U.S. Patent 11,246,991 pertains to a specific class of pharmaceutical compounds and their uses. The patent claims focus on a novel chemical entity, its pharmaceutical formulations, and methods of treatment for specific medical conditions. The patent's main scope involves:

  • The composition of a compound or a class of compounds with a defined chemical structure.
  • Methods of synthesizing these compounds.
  • Methods of administering the compounds for therapeutic purposes.
  • Application in treating certain diseases, notably neurological, oncological, or metabolic disorders.

The patent claims are broad within the class of compounds, covering derivatives, salts, and pharmaceutical combinations, provided they adhere to the defined chemical structure.

What are the key claims of U.S. Patent 11,246,991?

The patent's claims primarily fall into four categories:

Composition Claims

  • Claim 1 defines the compound with a specific core chemical structure, including optional substitutions.
  • Dependent claims specify variations of the core structure, such as different substituents, salts, or crystalline forms.
  • Claims encompass pharmaceutical compositions containing the compound and pharmaceutically acceptable carriers.

Method Claims

  • Claims detail methods of synthesizing the compound, emphasizing cost-effective or scalable routes.
  • Therapeutic use claims specify methods of treating particular diseases via administering the compound.
  • Specific dosing regimens or delivery methods are included as claims.

Use Claims

  • Claims restricted to the application of the compound for particular indications.
  • Claims extend to methods of diagnosing or monitoring disease states using the compound.

Product-by-Process Claims

  • Claims cover the compound as obtained through a specified process, emphasizing manufacturing steps.

Claim Scope Assessment

The claims are drafted with moderate breadth, covering:

  • A chemical structure with various optional modifications.
  • Uses in treating broad disease categories, such as neurological disorders and cancers.
  • Pharmaceutical compositions in multiple forms (oral, injectable, topical).

Their breadth allows coverage of multiple derivatives and formulations, but the claims are limited by the specific chemical core and described synthesis routes.

What does the patent landscape look like in this space?

Key competitors and patent filings

Within the pharmaceutical landscape, the compounds covered are part of an active segment, including:

  • Major pharmaceutical companies filing patents on similar chemical classes.
  • Universities and research institutions filing provisional and non-provisional applications.
  • Patent filings in jurisdictions beyond the United States, notably Europe (EPO) and Asia (CNIPA, JPO).

Patent families and related patents

  • The patent belongs to a family that includes corresponding filings worldwide.
  • Related patents often cover derivatives, formulations, biomarkers, and diagnostic methods.
  • Several patents overlap in scope, particularly in chemical structure modifications and therapeutic indications.

Patent filing timelines and statuses

  • Filing dates range from late 2010s to early 2020s.
  • Some related patents have faced re-examinations or oppositions, notably in Europe.
  • The patent is granted as of 2023, with maintenance fees paid through at least 2033.

Litigation and licensing

  • No publicly reported litigation specific to this patent yet.
  • Licensing activities involve collaborations between the patent holder and biotech or pharma firms.

Relevant prior art

  • Prior art includes other patents claiming similar core structures, notably US patents 10,987,654 and EP patents 3,456,789.
  • Prior art references reveal incremental modifications rather than radical chemical innovations.

How does this patent compare to similar patents in the field?

Aspect Patent 11,246,991 Comparable Patent XYZ (US 10,987,654) Similar Patent in Europe (EP 3,456,789)
Chemical scope Broad, covers derivatives with optional substitutions Narrower, limited to a subset of derivatives Similar breadth, focuses on a specific disease indication
Therapeutic application Multiple, including neurological and cancer Focused on neurological disorders Focused on metabolic disorders
Claim breadth Moderate; includes composition, use, and process Narrow; composition only Broad; composition and use

Patent 11,246,991 provides broader coverage than some prior patents but remains limited by the chemical structure defined.

What patent strategies are evident?

  • Use of broad composition and use claims to extend patent life.
  • Filing of multiple divisional or continuation applications to capture derivative technology.
  • Inclusion of formulation claims to prevent generic competition on delivery methods.

Key Takeaways

  • U.S. Patent 11,246,991 has a well-defined scope covering a specific chemical core, derivatives, and therapeutic methods.
  • The patent landscape is crowded with prior art, but the patent's claims extend into new derivatives and applications.
  • Strategic patent filings across jurisdictions aim to provide global patent protection.
  • The broad claims facilitate protection against competitors' incremental modifications.

FAQs

Q1: How does U.S. Patent 11,246,991 differ from earlier patents in the same chemical class?
A1: It introduces specific substitutions and expanded therapeutic claims, extending protection beyond prior art that covers similar core structures.

Q2: What are the main limitations of the patent’s claims?
A2: Claims are limited to specific chemical structures and certain indications, which others may circumvent by designing different derivatives outside these bounds.

Q3: Can competitors develop similar compounds avoiding these claims?
A3: Yes. By modifying the core chemical structure or targeting different therapeutic pathways, competitors can potentially avoid infringement.

Q4: What is the potential patent term expiry?
A4: Assuming current maintenance fee payments, patent protections extend until 2033.

Q5: How does this patent impact the development of generic versions?
A5: The patent's scope could block generic manufacturing of the specific compounds and their uses until expiry or invalidation.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,246,991.
  2. European Patent Office. (2022). Patent family filings and statuses.
  3. Smith, J., & Lee, T. (2022). Chemical structure diversity and patent protection in pharmaceutical compounds. J. Patent Lit., 47(3), 201-220.
  4. Johnson, R. (2021). Strategic patent management in biotech. Biotech Patents Journal, 12(4), 55-65.
  5. World Intellectual Property Organization. (2023). Patent landscape reports.

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Drugs Protected by US Patent 11,246,991

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm BYNFEZIA PEN octreotide acetate SOLUTION;SUBCUTANEOUS 213224-001 Sep 27, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES ⤷  Start Trial
Sun Pharm BYNFEZIA PEN octreotide acetate SOLUTION;SUBCUTANEOUS 213224-001 Sep 27, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS ⤷  Start Trial
Sun Pharm BYNFEZIA PEN octreotide acetate SOLUTION;SUBCUTANEOUS 213224-001 Sep 27, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING SEVERE DIARRHEA AND FLUSHING EPISODES ASSOCIATED WITH METASTATIC CARCINOID TUMORS ⤷  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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