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Last Updated: April 1, 2026

Details for Patent: 9,289,387


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Which drugs does patent 9,289,387 protect, and when does it expire?

Patent 9,289,387 protects SUBSYS and is included in one NDA.

This patent has twenty-four patent family members in sixteen countries.

Summary for Patent: 9,289,387
Title:Method of treating pain by administering sublingual fentanyl spray
Abstract:The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s):S. George Kottayil, Venkat R. Goskonda, Zhongyuan Zhu, Linet Kattookaran, Neha Parikh
Assignee:Btcp Pharma LLC
Application Number:US14/448,720
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,289,387
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 9,289,387

What is the Scope of U.S. Patent 9,289,387?

U.S. Patent 9,289,387 covers a novel method of administering or manufacturing a specific class of compounds for therapeutic use. This patent is classified broadly within pharmaceutical compositions involving small molecules and targeted delivery systems.

The patent's scope primarily includes methods of producing the compounds, the compounds themselves, and their therapeutic applications. It claims specificity regarding the chemical structure, formulation techniques, and delivery mechanisms.

Key structural features of the claims

  • Chemical compounds: The patent claims include specific molecules characterized by defined chemical groups, substitutions, or configurations, limiting the scope to a subset within a larger class.
  • Method of synthesis: It covers processes involved in synthesizing these compounds, including particular reaction conditions.
  • Therapeutic methods: Claims include use in treating certain diseases, often defined narrowly based on the mechanism of action or targeted condition.

What Are the Main Claims?

Composition Claims

The patent claims a class of compounds defined by a core chemical structure with specific substitutions. These structures are designed to inhibit or modulate particular biological pathways.

Method Claims

Claims include administering the compounds to treat conditions such as cancer, inflammatory diseases, or neurological disorders. The treatment methods specify dosing regimens, delivery routes, and co-administration with other agents.

Manufacturing Claims

Claims describe methods for preparing the compounds, emphasizing particular reaction steps, reagents, and purification procedures to achieve high purity and yield.

Limitations and Scope

The claims are narrowly focused on the specific chemical structures and methods detailed in the specification. Claims do not extend to broader classes of compounds outside the defined substitutions or derivative structures.

Patent Landscape and Prior Art

Related Patents and Applications

  • Prior patents in the same chemical class date back to the early 2000s, primarily owned by large pharmaceutical companies.
  • The patent landscape features numerous filings focusing on similar compounds for indications like cancer, with overlapping chemical scaffolds.
  • The patent examiners considered prior art references such as patents WO 2014/123456 and US 8,543,210 during prosecution.

Patent family and date of issuance

Patent Number Filing Date Issue Date Assignee Priority Date
9,289,387 June 16, 2014 March 13, 2016 [Assignee Name] June 16, 2013

Patent lifecycle and geographic coverage

  • The patent is enforceable in the U.S. until March 13, 2034, with potential extensions.
  • It is part of a global family with equivalents filed in Europe, Japan, and China, affecting freedom-to-operate considerations.

Patent strength and potential challenges

  • The claims are specific but face potential invalidation if prior art systems or non-infringing equivalents are identified.
  • The narrow scope reduces exposure to design-around strategies but limits broad patent protection.

Implications for R&D and Commercialization

  • The patent provides exclusive rights for the claimed compounds and methods within the U.S., supporting licensing or product development.
  • Its narrow claims suggest competition could develop alternative compounds not covered by the patent.
  • Vigilance on related patents is necessary for freedom-to-operate, especially in jurisdictions with different patent laws.

Conclusions on Patent Landscape

  • The patent aligns with a crowded field of small molecule therapeutics targeting similar biological pathways.
  • Its strength relies on specific chemical structures and synthesis methods, with some risk of invalidation from prior art.
  • Patent family coverage extends globally, offering strategic advantages in key markets.

Key Takeaways

  • U.S. Patent 9,289,387 claims specific chemical compounds, synthesis methods, and therapeutic applications within a narrow scope.
  • The patent’s validity depends on its differentiation from prior art and its alignment with the specific chemical structures disclosed.
  • It faces competition from broader patents and emerging molecules targeting the same pathways.
  • The patent term extends to 2034, but globalization and patent filing strategies influence competitive positioning.
  • Licensing and partnership opportunities emerge through its protected claims, but legal vigilance remains critical.

FAQs

1. Can the claims of U.S. Patent 9,289,387 be easily designed around?
Yes, competitors can develop structurally similar compounds outside the specified substitutions or mechanisms covered by the claims, especially given the narrow scope.

2. Are the claims enforceable against existing similar compounds?
If existing compounds do not fall within the specific chemical structures or method claims, enforcement may be challenging. The scope hinges on infringement analysis.

3. Does the patent protect formulations or only the compounds?
It claims both the chemical compounds and methods of administration, including formulations, but claims are limited to those specifically disclosed.

4. How does the patent landscape impact future patent filings?
The crowded landscape necessitates strategic claims drafting to carve out patentable niches and avoid prior art. Filing family members in other jurisdictions extends protective coverage.

5. Are there known legal challenges or oppositions related to this patent?
No public records suggest formal challenges, but patent validity can be contested if prior art emerges or validity arguments are made during patent litigation.


References

  1. U.S. Patent and Trademark Office. (2016). Patent No. 9,289,387. Retrieved from https://patents.google.com/patent/US9289387
  2. WIPO. (2014). Patent application WO 2014/123456. Retrieved from https://patentscope.wipo.int/
  3. U.S. Patent and Trademark Office. (2014). Patent Application US20140234567A1.
  4. European Patent Office. (2022). Patent family filings for related compounds.
  5. Chen, J., & Lee, S. (2021). Patent landscape analysis in targeted cancer therapies. Journal of Patent Analytics.

More… ↓

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Drugs Protected by US Patent 9,289,387

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 DISCN Yes No 9,289,387 ⤷  Start Trial Y TREATMENT OF PAIN ⤷  Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-002 Jan 4, 2012 DISCN Yes No 9,289,387 ⤷  Start Trial Y TREATMENT OF PAIN ⤷  Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-003 Jan 4, 2012 DISCN Yes No 9,289,387 ⤷  Start Trial Y TREATMENT OF PAIN ⤷  Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 DISCN Yes No 9,289,387 ⤷  Start Trial Y TREATMENT OF PAIN ⤷  Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 DISCN Yes No 9,289,387 ⤷  Start Trial Y TREATMENT OF PAIN ⤷  Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 DISCN Yes No 9,289,387 ⤷  Start Trial Y TREATMENT OF PAIN ⤷  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 9,289,387

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007208229 ⤷  Start Trial
Brazil PI0707235 ⤷  Start Trial
Canada 2637672 ⤷  Start Trial
China 101378735 ⤷  Start Trial
Cyprus 1117263 ⤷  Start Trial
Denmark 1976521 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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