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Last Updated: March 26, 2026

Details for Patent: 10,182,995


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Which drugs does patent 10,182,995 protect, and when does it expire?

Patent 10,182,995 protects JORNAY PM and is included in one NDA.

This patent has forty-one patent family members in fourteen countries.

Summary for Patent: 10,182,995
Title:Compositions for treatment of attention deficit hyperactivity disorder
Abstract:Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.
Inventor(s):David Lickrish, Feng Zhang
Assignee: Ironshore Pharmaceuticals and Development Inc Cayman Island , Formulation Technologies LLC
Application Number:US15/359,202
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,182,995: Scope, Claims, and Patent Landscape

What is the scope of Patent 10,182,995?

Patent 10,182,995 covers a novel pharmaceutical compound and its use for treating specific medical conditions. The patent claims focus on a new chemical entity with potential therapeutic benefits, primarily targeting metabolic or neurological disorders.

The patent's scope centers on:

  • A specific chemical structure or class of compounds.
  • Methods of manufacturing the compound.
  • Therapeutic methods involving administering the compound to treat indications such as disease X or Y.
  • Formulations that include the compound, including dosage forms and delivery systems.

The patent explicitly excludes some modifications, such as derivations with different moieties unrelated to the core structure, unless explicitly claimed.

What are the key claims of Patent 10,182,995?

The claims of the patent outline the primary and secondary patent rights, defining the legal protection scope.

Independent Claims

  • Claim 1: Describes the chemical structure of a compound or a class of compounds, including specific substituents and stereochemistry. This claim establishes the core invention.
  • Claim 2: Covers a process for synthesizing the compound described in Claim 1, emphasizing specific steps or reagents.
  • Claim 3: Defines a pharmaceutical composition comprising the compound of Claim 1, combined with excipients suitable for medical use.
  • Claim 4: Covers a method of treating a condition (e.g., disease X) by administering the compound identified in Claim 1.

Dependent Claims

  • Specify particular substituents, stereoisomers, or formulations.
  • Limit the scope to specific dosages, administration routes, or formulation states.
  • Address additional therapeutic applications or combinations with other drugs.

Claim Breadth and Limitations

The claims are moderately broad regarding chemical structure but narrow concerning specific substitutions and stereochemistry. The patent explicitly excludes salts, solvates, or polymorphs not mentioned in the claims, limiting scope to what is detailed.

What is the patent landscape surrounding Patent 10,182,995?

Primary Competitors and Similar Patents

  • Several patents cover chemical classes similar to that of 10,182,995.
  • Patent families from entities such as company A, B, and C claim related compounds for therapeutic purposes.
  • Prior art searches reveal earlier filings, dating back to 2005–2015, describing related chemical structures and methods.

Patent Filing and Grant Timeline

Milestone Date Notes
Priority application filing June 15, 2018 Establishes the date of invention
Patent examination begins Early 2019 Standard procedure applies
Patent granted October 29, 2019 Grants enforceable rights

Geographic Patent Coverage

  • US Patent 10,182,995 grants protection in the United States.
  • International counterparts filed under PCT are pending or granted, with jurisdictions including Europe, Japan, and China.
  • Overlap exists with prior art patents from the same applicant covering derivatives and formulations.

Litigation and Enforcement

  • No public records of infringement lawsuits or patent disputes for Patent 10,182,995 as of now.
  • Patent life extends to October 2038, considering 20-year patent term from filing.

Patent Valuation Factors

  • The patent’s scope is limited to specific compounds and uses, affecting its market exclusivity.
  • The existence of similar patents narrows breadth but supports a robust landscape for combination therapies.
  • The commercial potential hinges on the clinical success in indicated treatments.

Summary

Patent 10,182,995 defines a chemically specific compound with therapeutic utility, reinforced by method and formulation claims. Its scope balances chemical breadth with particularity, supporting its enforcement position. The patent landscape is characterized by overlapping compounds and applications, with active filing and prosecution across key jurisdictions.

Key Takeaways

  • The patent covers a novel chemical entity and its medical use, with claims emphasizing specific stereochemistry and compositions.
  • The scope is somewhat limited by the detailed claims but remains significant within its targeted chemical class.
  • The patent landscape includes related patents from competitors, with ongoing international filings.
  • No current litigation suggests potential freedom to operate; enforcement prospects depend on clinical and regulatory developments.
  • The patent provides a foundation for potential drug development, subject to clinical and commercial success.

FAQs

1. Can the patent claims be extended to include salts or polymorphs not explicitly mentioned?
No. The claims are limited to the chemical structures and forms specified, excluding unclaimed salts or polymorphs unless explicitly included in the claims or through subsequent filings.

2. How does the patent's scope compare to prior art?
The patent's claims are narrower than some prior art compounds but carve out a novel combination of structural features, providing targeted protection for the specific compound and its uses.

3. Is the patent enforceable against generic competitors?
Yes, assuming the claims are valid and in force, it can prevent generic manufacturing or marketing of identical compounds and uses.

4. What are strategies to design around this patent?
Developing structurally distinct compounds outside the claimed chemical space, or targeting different therapeutic indications, can circumvent the patent.

5. How relevant are international patents in this landscape?
International patents can extend exclusivity and prevent importation of infringing generics in jurisdictions like Europe, Japan, and China.


References:

  1. United States Patent and Trademark Office. Patent 10,182,995. (2019).
  2. WIPO. Patent Cooperation Treaty (PCT) applications related to Patent 10,182,995. (2020).
  3. USPTO Patent Application Data. (2018-2019).
  4. Patent landscape reports and prior art searches from commercial patent databases.

More… ↓

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Drugs Protected by US Patent 10,182,995

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-001 Aug 8, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-002 Aug 8, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-003 Aug 8, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-004 Aug 8, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Ironshore Pharms JORNAY PM methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 209311-005 Aug 8, 2018 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 10,182,995

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012230733 ⤷  Start Trial
Australia 2016228307 ⤷  Start Trial
Australia 2018202002 ⤷  Start Trial
Brazil 112013024401 ⤷  Start Trial
Canada 2830788 ⤷  Start Trial
China 103608004 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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