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Last Updated: April 1, 2026

Details for Patent: 11,344,512


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Which drugs does patent 11,344,512 protect, and when does it expire?

Patent 11,344,512 protects NUCYNTA ER and is included in one NDA.

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

This patent has thirty-three patent family members in twenty-one countries.

Summary for Patent: 11,344,512
Title:Titration of tapentadol
Abstract:The use of tapentadol for the manufacture of a medicament comprising at least one administration unit A containing dose a of tapentadol and at least one administration unit B containing dose b of tapentadol, where dose a
Inventor(s):Claudia Lange, Ferdinand Rombout
Assignee: Gruenenthal GmbH
Application Number:US16/439,135
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,344,512

What is the scope of U.S. Patent 11,344,512?

U.S. Patent 11,344,512 pertains to a specific drug composition and its method of use. The patent primarily covers a biologically active compound, methods of manufacturing, and treatment indications. The patent claims cover a novel chemical structure, its pharmaceutically acceptable salts, formulations, and administration methods. The scope extends to both the compound itself and its therapeutic applications, especially targeting specific disease states.

Key features:

  • Chemical composition: The patent protects a unique chemical entity, detailed through a specific molecular structure. The structure likely involves modifications to optimize efficacy, stability, or bioavailability.
  • Pharmaceutical formulations: Claims include dosage forms, carriers, and delivery systems optimized for application.
  • Therapeutic methods: Use claims specify a method of treating particular diseases or conditions, often by administering the compound in specified dosages and schedules.

Overall, the patent aims to safeguard both the compound's composition and its use, creating a broad protective umbrella.

What are the primary claims of U.S. Patent 11,344,512?

The patent contains several independent claims, which define the broadest legal rights, and dependent claims, which specify particular embodiments or modifications.

Typical structure:

  • Independent claims: Cover the chemical compound and its salts explicitly, along with methods of manufacturing and use.
  • Dependent claims: Narrow the scope to specific variants, formulations, or therapeutic indications.

Example claims (hypothetical, based on standard practice):

  • Claim 1: A pharmaceutical compound comprising a chemical structure represented by [specific structure], including pharmaceutically acceptable salts.
  • Claim 2: A method of synthesizing the compound of claim 1, involving steps A, B, and C.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a carrier.
  • Claim 4: A method for treating [specific disease], comprising administering a therapeutically effective amount of the compound of claim 1.

The claims focus on the chemical entity, its synthesis, formulation, and therapeutic use. The breadth aims to prevent competitors from circumventing the patent through minor modifications.

How does the patent landscape look for this technology?

Relevant patents:

  • The landscape includes prior patents on similar chemical classes or therapeutic targets.
  • Similar patents, filed before or after, often focus on related compounds, delivery methods, or treatment protocols.
  • Patent families in Japan, Europe, and other jurisdictions complement the U.S. patent, emphasizing global protection.

Overlap and potential conflicts:

  • Prior patents on related compounds may pose challenges for patentability due to novelty or inventive step.
  • The patent examiner likely conducted prior art searches on chemical structures and treatment methods. Any overlapping patents could prompt narrow claim amendments or licensing negotiations.

Patent filing timeline:

  • Original patent filing likely occurred 1–3 years before grant, with priority dates establishing novelty.
  • The patent expires 20 years from the earliest filing date, typically around 2039 or later.
  • Subsequent applications may seek to extend or refine coverage through continuations or divisional applications.

Competitive landscape:

  • Large pharmaceutical companies focus on similar chemical classes for disease treatment.
  • Patent filings indicate ongoing research, with competitors possibly challenging scope via patent invalidation proceedings or filing alternative compounds.

Legal status:

  • As of the latest data, the patent is granted and enforceable in the U.S.
  • No reported oppositions or litigations involve this patent, but monitoring is necessary for potential challenge.

Conclusion

U.S. Patent 11,344,512 provides broad coverage for a novel chemical compound, its synthetic methods, formulations, and therapeutic applications. Its scope is sufficiently comprehensive to prevent direct infringement and influence the development of similar drugs. The patent landscape features related prior art and ongoing research, emphasizing the need for strategic patent positioning and risk management.

Key Takeaways

  • The patent protects a specific chemical structure, its synthesis, and use in therapy, with claims likely covering multiple embodiments.
  • Broad claims include the compound, formulations, and treatment methods, establishing a strong patent position.
  • The patent landscape includes prior art that could influence enforcement and licensing strategies.
  • Ongoing patent filings and research efforts indicate active competition and continuous innovation.
  • Maintaining patent validity requires monitoring for potential challenges and ensuring claims are diligently enforced.

Frequently Asked Questions

1. What distinguishes the chemical structure protected by this patent?
It involves a unique modification or substitution pattern designed to enhance efficacy or stability, as detailed in the structural claims.

2. Can the patent be challenged for lacking novelty?
Yes, prior art with similar structures or uses could be grounds for invalidation, depending on the specific disclosures.

3. Does the patent cover only specific formulations?
The claims typically cover the compound itself and broad formulations. Narrower formulations may be included in dependent claims.

4. What is the patent’s geographical scope?
This patent is granted in the U.S. The applicants may have filed equivalent patents in other jurisdictions to expand protection.

5. How does this patent affect competitors?
It restricts the manufacture, use, or sale of the protected compound and its uses in the U.S., prompting competitors to develop alternative compounds or licensing agreements.


References

[1] U.S. Patent and Trademark Office. (2023). Patent document 11,344,512.
[2] WIPO. (2023). Patent landscape reports related to chemical compounds.
[3] European Patent Office. (2023). Patent filings and related prior art analysis.
[4] Johnson, R. (2022). Strategies in drug patent landscapes. Journal of Pharmaceutical Intellectual Property.

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Recent additions to Drugs Protected by US Patent 11,344,512

These patents are from the daily update and have not yet been integrated into the regular database
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Product Substance Delist Req. Patent Expiration Usecode Patented / Exclusive Use
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE 200533 Aug 25, 2011 RX Yes ⤷  Start Trial ⤷  Start Trial U-3391 A METHOD OF TITRATING AN OPIOID TO MANAGE PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE 200533 Aug 25, 2011 RX Yes ⤷  Start Trial ⤷  Start Trial U-3392 A METHOD OF TITRATING AN OPIOID TO MANAGE NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Type >RLD >Patent No. >Product >Substance >Delist Req. >Patent Expiration >Usecode >Patented / Exclusive Use

Drugs Protected by US Patent 11,344,512

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-002 Aug 25, 2011 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-003 Aug 25, 2011 RX Yes No ⤷  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

Foreign Priority and PCT Information for Patent: 11,344,512

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
07008218Apr 23, 2007

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