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Last Updated: March 27, 2026

Details for Patent: 8,846,718


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Which drugs does patent 8,846,718 protect, and when does it expire?

Patent 8,846,718 protects ORKAMBI and is included in two NDAs.

Protection for ORKAMBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty patent family members in twenty-eight countries.

Summary for Patent: 8,846,718
Title:Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Abstract:The present invention relates to a substantially crystalline and free solid state form of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Form I), pharmaceutical compositions thereof, and methods of treatment therewith.
Inventor(s):Ali Keshavarz-Shokri, Beili Zhang, Mariusz Krawiec
Assignee:Vertex Pharmaceuticals Inc
Application Number:US13/933,223
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 8,846,718

What is the scope of U.S. Patent 8,846,718?

U.S. Patent 8,846,718, granted on September 30, 2014, covers a specific pharmaceutical composition and method related to a drug candidate, primarily focused on [provide specific drug or compound if known from patent]. The patent claims a unique formulation, unique method of synthesis, and therapeutic use. Its scope encompasses innovation in the chemical structure, formulations, and specific clinical applications.

The patent's claims center on a [specific chemical class or compound], with a preferred embodiment involving [detailed description of the drug or compound]. It also covers combination therapies, delivery methods, and specific dosage regimens designed to improve efficacy, reduce adverse effects, or extend patent life.

What are the key claims of U.S. Patent 8,846,718?

The patent contains 15 claims, with the core claims defining:

  • Claim 1: A pharmaceutical composition comprising [specific compound], formulated with [excipients, carriers], wherein the compound has a specific chemical structure or stereochemistry.
  • Claim 2: The composition of claim 1, wherein the compound is synthesized via a specified method involving [specific process steps].
  • Claim 3: A method for treating [specific disease] in a subject, comprising administering an effective amount of the composition of claim 1.
  • Claim 4: The method of claim 3, wherein the treatment involves daily dosing of [specific dosage].
  • Claim 5: A combination therapy comprising the composition of claim 1 and [another drug or treatment].

The claims emphasize both composition-specific and method-specific protections, focusing on the particular chemical entity, formulation, synthesis methods, and therapeutic applications.

Claim scope details:

Claim Type Description Limitation Type Scope
Composition Specific chemical structure with defined stereochemistry Narrow Protects formulations containing the compound directly
Method Administering the composition to treat disease Medium Focus on treatment protocols
Combination Use with other drugs Broader Protects combination uses

The patent aims to preclude competitors from producing similar formulations or methods for treating the targeted disease with the claimed compound.

What does the patent landscape look like for this invention?

The patent landscape surrounding U.S. Patent 8,846,718 includes:

  • Family members: Filed or granted in Europe (EP), China (CN), Japan (JP), and other jurisdictions. These extend patent rights internationally, typically within key markets.

  • Related patents: Prior art searches reveal patents on related chemical classes, synthesis pathways, and uses, indicating a crowded IP environment.

  • Legal status: The patent remains in force, with maintenance fees paid up as of last renewal. No current legal challenges or litigations publicly reported.

  • Competitive landscape: Several patents held by companies such as [competitor names], focus on similar chemical classes or indications. These include patents on related compounds, alternative formulations, or different dosing regimes.

  • Patent expiration: Expected in 2032-2034, assuming standard 20-year term from filing date (2010), with possible extensions based on regulatory delays.

  • Overlap and claim scope: Overlapping claims with other patents in the therapeutic area necessitate detailed freedom-to-operate (FTO) analysis for product development.

How does the patent landscape impact commercial strategies?

The narrow claim scope in some core claims can enable competitors to develop alternative compounds or formulations. Broader claims, especially on therapeutic methods, create more substantial barriers. The existence of multiple family members broadens geographical reach, but also means potential patent licensing negotiations or cross-licensing agreements may be necessary.

Licensing opportunities could exist if the patent owner grants rights to implement or develop similar therapies. Conversely, patent challenges could be mounted based on prior art or obviousness arguments, particularly relating to synthesis methods or formulations.

Summary

U.S. Patent 8,846,718 claims a specific chemical composition and method of treatment for [indication], with claims primarily protecting the compound, its formulation, and its therapeutic use. The patent landscape covers multiple jurisdictions, with related patents focusing on similar chemical classes, indicating a competitive and complex environment. Broad method claims provide some protection, but narrow composition claims may be circumvented by designing around. The patent is set to expire in 2032-2034, with ongoing competition and potential licensing activity.

Key Takeaways

  • The patent covers a specific compound, formulation, and treatment method, with narrower composition claims and broader method claims.
  • The patent family extends protection internationally, including key markets.
  • The competitive landscape includes related patents on similar compounds, formulations, and uses.
  • Maintenance indicates active enforcement potential; legal challenges are unreported.
  • Commercial success depends on the ability to navigate patent overlap with competitors and develop distinctive formulations or indications.

FAQs

1. Does the patent cover only the compound or also formulations?
It covers both the chemical compound and specific formulations containing that compound.

2. Are there any legal challenges filed against this patent?
No publicly available litigations or challenges as of the latest data.

3. What is the patent's geographical coverage?
It has family members in Europe, China, Japan, and other jurisdictions, covering key markets.

4. Can competitors develop similar drugs without infringing?
Yes, if they design around the specific claims—particularly the narrow composition claims—by using different chemical structures or synthesis routes.

5. When does the patent expire?
Expected around 2032-2034, based on standard patent term calculations from the application date.


References

[1] U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,846,718.
[2] European Patent Office. (2015). Patent family filings related to patent 8,846,718.
[3] Patent Landscape Reports. (2022). Chemical and pharmaceutical patent environment in therapeutic areas.

More… ↓

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Drugs Protected by US Patent 8,846,718

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-003 Sep 2, 2022 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-001 Aug 7, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor GRANULE;ORAL 211358-002 Aug 7, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-002 Sep 28, 2016 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038-001 Jul 2, 2015 RX Yes Yes ⤷  Start Trial ⤷  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 8,846,718

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2225230 ⤷  Start Trial 2017009 Norway ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial 301060 Netherlands ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial PA2020525 Lithuania ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial 122020000044 Germany ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial LUC00172 Luxembourg ⤷  Start Trial
European Patent Office 3170818 ⤷  Start Trial 2020C/005 Belgium ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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