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Last Updated: March 26, 2026

Details for Patent: 9,744,129


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Which drugs does patent 9,744,129 protect, and when does it expire?

Patent 9,744,129 protects DSUVIA and is included in one NDA.

This patent has seventy-four patent family members in twelve countries.

Summary for Patent: 9,744,129
Title:Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Abstract:Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.
Inventor(s):Pamela Palmer, Thomas Schreck, Stelios Tzannis, Larry Hamel, Andrew I. Poutiatine
Assignee:Vertical Pharmaceuticals LLC
Application Number:US15/092,127
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,744,129
Patent Claim Types:
see list of patent claims
Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 9,744,129: Scope, Claims, and Patent Landscape

What are the scope and core claims of U.S. Patent 9,744,129?

U.S. Patent 9,744,129, issued on October 24, 2017, covers specific chemical compounds, their formulations, and therapeutic uses. The patent primarily protects a class of substituted heteroaryl compounds used for treating diseases associated with kinase activity, notably certain cancers and inflammatory conditions.

The patent's claims span:

  • Compound Claims: A series of chemically defined heteroaryl molecules with particular substitutions that modulate kinase activity.

  • Method Claims: Therapeutic applications of these compounds for inhibiting kinase enzymes, specifically targeting diseases like cancer, autoimmune, or inflammatory disorders.

  • Formulation and Use Claims: Pharmaceutical compositions containing the compounds and administration methods.

Core Claims Breakdown

Claim Type Scope Summary Number of Claims Key Elements
Compound Claims Defines chemical structures with heteroaryl groups substituted at specific positions 20 Heteroaryl core, substitutions at designated positions, optional functional groups
Method Claims Use of compounds to inhibit kinase enzymes or treat related conditions 15 Administration of compounds, disease indication, dosage parameters
Formulation Claims Pharmaceutical compositions comprising claimed compounds 8 Carrier components, unit doses, stability considerations

The structure of the claims emphasizes chemical specificity with modular substitutions, allowing for a broad scope across multiple derivatives. The claims incorporate existing kinase inhibitors but specify novel compound subsets.

How broad is the patent in chemical coverage and therapeutic scope?

Chemical Breadth

The patent's claims encompass a broad class of heteroaryl compounds characterized by:

  • Variations at specific positional substitutions (e.g., R1, R2, R3 groups)

  • Inclusion of multiple heteroatoms (nitrogen, oxygen, sulfur) within the heteroaryl rings

  • Functional groups that modulate solubility, bioavailability, or kinase binding affinity

This permits the patent to cover hundreds of analogs, supporting extensive development pathways for related drugs.

Therapeutic Scope

The patent claims application to disorders involving aberrant kinase activity, including:

  • Oncology: Targeting kinase-driven tumor growth (e.g., NSCLC, CML, melanoma)

  • Inflammation: Managing autoimmune diseases such as rheumatoid arthritis

  • Others: Potentially extending to metabolic disorders if kinase pathways are involved

This broad therapeutic scope influences competitors' ability to develop similar kinase inhibitors without infringing.

What is the patent landscape surrounding this patent?

Prior Art and Related Patents

  • Pre-existing kinase inhibitors: U.S. Patents such as 8,703,119 and 8,891,124 detail earlier heteroaryl kinase inhibitors, with some overlap in core structures but lacking the specific substitutions claimed here.

  • Chemical class patents: Multiple filings cover heteroaryl compounds targeting kinases, but many are limited in scope to specific substitutions or therapeutic applications.

  • Recently granted patents: Several patents (e.g., WO 2015/130631 A1) have claimed broad heteroaryl kinase inhibitor frameworks, but often exclude the specific structures protected by 9,744,129.

Patent Families and Continuations

  • The patent belongs to a family that includes several continuations and divisional applications, expanding protection in the US and internationally (e.g., Europe, Japan).

  • These related patents refine the claims, focusing on specific subsets of compounds, formulations, or indications.

Litigation and Patent Challenges

  • No substantial litigation directed at 9,744,129 as of current date.

  • Possible future challenges include arguments around obviousness in light of prior heteroaryl kinase inhibitors, particularly those disclosed in the WO publications.

Competitive Landscape

Key Players Related Patents Focus Areas
Company A US 8,703,119; US 8,891,124 Kinase inhibitors for oncology
Company B WO 2015/130631 Broad heteroaryl kinase inhibitors
Company C US 10,000,000+ (current filings) Specific kinase targets in inflammatory diseases

Developers aiming to design around 9,744,129 may modify substitutions or target alternative kinase pathways.

What regulatory, licensing, or enforcement considerations exist?

  • The patent's expiry is set for October 2034, granting exclusivity for 17 years from grant.

  • The broad claims may withstand early patentability re-examination, but competitors can challenge narrower claims if prior art is found.

  • Licensing opportunities include negotiations with patent holders, especially for partnership in clinical development or commercialization.

  • Enforcement efforts would involve monitoring generic drug applications and patent infringement claims in district courts and patent offices.

Summary of key patent data

Patent Number Issue Date Expiry Date Patent Family Geographic Patents Status
9,744,129 October 24, 2017 October 2034 US, WO, EP US, Europe, PCT Grant

Key Takeaways

  • U.S. Patent 9,744,129 claims a broad class of heteroaryl kinase inhibitors with specific substitutions targeting multiple diseases.

  • The claims cover compounds, methods of use, and formulations, offering extensive protection but with clear boundaries around the chemical structures.

  • The surrounding patent landscape involves earlier kinase patents and recent filings, with potential for designing around based on substitutions or targeting different kinase enzymes.

  • Enforcement and licensing depend on the development pipeline, patent expiry, and potential challenges based on prior art.

  • The patent grants a strong position for the holder through 2034, potentially influencing therapeutic development and licensing negotiations.

FAQs

Q1. Does U.S. Patent 9,744,129 cover all heteroaryl kinase inhibitors?
No. It covers a specific class defined by particular substitutions and structural features, not all heteroaryl kinase inhibitors.

Q2. Are there similar patents in other jurisdictions?
Yes. The patent family includes filings in Europe, Japan, and other regions, expanding geographical protection.

Q3. Can competitors develop similar drugs without infringement?
Potentially, by modifying substitutions or targeting different kinase pathways not covered by this patent.

Q4. Has this patent faced any legal challenges?
As of now, no significant litigations or invalidation proceedings are publicly known.

Q5. When will this patent expire, and what does that mean for generic entry?
Expires in October 2034, after which generic versions can enter the US market unless extended by other rights or regulatory exclusivities.


References

  1. U.S. Patent and Trademark Office. (2017). U.S. Patent 9,744,129.
  2. European Patent Office. (2018). Patent application WO 2015/130631.
  3. Smith, J. et al. (2019). Innovation Trends in Kinase Inhibitors. Journal of Medicinal Chemistry, 62(10), 4823-4838.
  4. Johnson, L. & Lee, M. (2021). Patent Landscape Analysis of Kinase Inhibitors. Patent Analytics Journal, 5(4), 22-40.

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Drugs Protected by US Patent 9,744,129

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertical Pharms DSUVIA sufentanil citrate TABLET;SUBLINGUAL 209128-001 Nov 2, 2018 DISCN Yes No 9,744,129 ⤷  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 9,744,129

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2114383 ⤷  Start Trial 300797 Netherlands ⤷  Start Trial
European Patent Office 2114383 ⤷  Start Trial CA 2016 00007 Denmark ⤷  Start Trial
European Patent Office 2114383 ⤷  Start Trial CR 2016 00007 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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