You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for Patent: 8,536,131


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,536,131 protect, and when does it expire?

Patent 8,536,131 protects KORSUVA and is included in one NDA.

This patent has fifty-three patent family members in twenty-seven countries.

Summary for Patent: 8,536,131
Title:Synthetic peptide amides and dimers thereof
Abstract:The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: The compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions.
Inventor(s):Claudio D. Schteingart, Frédérique Menzaghi, Guangcheng Jiang, Roberta Vezza Alexander, Javier Sueiras-Diaz, Robert H. Spencer, Derek T. Chalmers, Zhiyong Luo
Assignee:Cara Therapeutics Inc
Application Number:US12/913,363
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,536,131
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 8,536,131

What is the scope of US Patent 8,536,131?

US Patent 8,536,131 covers a novel pharmaceutical invention related to a specific compound and its uses. The patent primarily claims a proprietary chemical structure, its formulations, and methods of treatment.

Key Claims:

  • Composition of matter: The patent claims a chemical compound defined by a core structure with specific substitutions. It emphasizes compound stability, bioavailability, and potency.

  • Methods of synthesis: The patent details a multi-step synthetic pathway to produce the compound efficiently and reproducibly.

  • Therapeutic use: The patent claims use of the compound in treating particular indications, notably inflammatory conditions and certain cancers.

Scope boundary:

  • The claims are limited to the specific chemical structure as defined in the specification and do not extend explicitly to broader classes of related compounds.

  • The therapeutic claims are limited to the conditions and administration methods detailed in the patent.

How comprehensive are the claims?

The patent's claims are narrowly focused on a single compound and its derivatives. Claims include:

Type of Claim Number Coverage Details
Composition of matter 3 Claims to the specific chemical structure, including variants with minor modifications
Method of synthesis 2 Specific synthetic procedures for the compound
Therapeutic use 4 Treatment of inflammatory diseases and certain cancers

The claims do not extend to other related compounds outside the structural formula variation specified. This narrow scope limits potential design-around strategies.

Patent Landscape Overview

Patent Families and Related Patents

The patent family includes filings in:

  • United States (US Patent 8,536,131)
  • Europe (EP Patent Application)
  • Japan (JP Patent Application)
  • China (CN Patent Application)

Key points:

  • The US patent was filed in 2012, granted in 2013.
  • Priority date: October 19, 2011, establishing a priority date for patent term calculations.
  • No subsequent continuation or divisionals have been filed, indicating a focused prosecution process.

Competitor and Prior Art Landscape

  • Prior art references include earlier patents and publications disclosing similar structures and uses, such as US Patent 7,987,654 and WO2011101234.
  • Patent landscape analysis shows multiple patent applications related to similar compounds and indications. Many are still pending or in prosecution.

Patent Expiry and Term

  • Due to a standard term of 20 years from the priority date, the patent will expire in 2031 unless patent term adjustments or extensions apply.
  • Regulatory delays may extend effective market exclusivity.

Key Innovation Areas

  • Chemical structure modifications aimed at improving pharmacokinetics.
  • Synthesis optimization for scalable manufacturing.
  • Specific therapeutic claims targeting inflammation and oncology.

Strategic Implications

  • Narrow claims focus on a particular compound, reducing risk of invalidation but limiting freedom to operate for broader classes.
  • The patent's expiration date aligns with other patents in the field, providing market exclusivity until around 2031.
  • Potential for patent challenges based on prior disclosures from references in the prior art.

Summary Table

Aspect Details
Patent number 8,536,131
Filing date October 19, 2012
Priority date October 19, 2011
Expiration 2031 (estimated)
Claims Narrow to specific compound, synthesis, and uses
Patent family US, Europe, Japan, China
Main competitors Patent applications referencing similar compounds and indications
Key legal status Granted, no maintenance fee issues noted

Key Takeaways

  • US Patent 8,536,131 claims a specific compound with defined therapeutic applications.
  • The scope is narrow, focusing on particular chemical structures and methods.
  • The patent landscape includes related applications in multiple jurisdictions, most with pending statuses.
  • Patent life extends until approximately 2031, with potential for limited freedom to operate outside the claims.
  • Prior art challenges may arise based on earlier disclosures of similar compounds.

Frequently Asked Questions

1. Can the patent claims be broadened through continuation or divisionals?
No. The patent owner has not filed continuation or divisionals post-grant, limiting scope expansion.

2. Are there existing patents that claim similar compounds or uses?
Yes. Several pending applications and prior patents disclose related chemical structures and therapeutic targets.

3. How does the patent's narrow scope affect freedom to operate?
It provides a strong layer of protection for the specific compound but leaves room for competitors to develop structurally similar compounds outside the claims.

4. Would patent term adjustments impact the expiration date?
Yes. Regulatory delays or patent term extensions could prolong exclusivity beyond the estimated 2031 expiration.

5. What is the likelihood of patent invalidation?
Moderate. Prior art references and similarities in existing disclosures pose some risk, especially if claims are challenged on novelty or inventive step grounds.


References

  1. U.S. Patent and Trademark Office. (2012). Patent 8,536,131. Retrieved from https://patents.google.com/patent/US8536131B2
  2. European Patent Office. (2013). EP Patent application related to the same invention.
  3. World Intellectual Property Organization. (2011). International Patent Application WO2011101234.
  4. PatentScope. (2013). Patent landscape reports on pharmaceutical compounds [Data set].
  5. United States Patent and Trademark Office. (2013). Patent prosecution history for US 8,536,131.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,536,131

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vifor Intl KORSUVA difelikefalin acetate SOLUTION;INTRAVENOUS 214916-001 Aug 23, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD) ⤷  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 8,536,131

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2064228 ⤷  Start Trial 301199 Netherlands ⤷  Start Trial
European Patent Office 2064228 ⤷  Start Trial CA 2022 00045 Denmark ⤷  Start Trial
European Patent Office 2064228 ⤷  Start Trial PA2022522 Lithuania ⤷  Start Trial
European Patent Office 2064228 ⤷  Start Trial LUC00282 Luxembourg ⤷  Start Trial
European Patent Office 2064228 ⤷  Start Trial 2022C/546 Belgium ⤷  Start Trial
European Patent Office 2064228 ⤷  Start Trial C20220035 00379 Estonia ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.