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

Last Updated: April 2, 2026

Details for Patent: 7,988,994


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 7,988,994 protect, and when does it expire?

Patent 7,988,994 protects ESBRIET and is included in one NDA.

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

Summary for Patent: 7,988,994
Title:Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Abstract:A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.
Inventor(s):Ramachandran Radhakrishnan, Ronald Vladyka, Kenneth Sultzbaugh
Assignee:LEGACY PHARMA INC. SEZC
Application Number:US12/067,712
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,988,994
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Patent 7,988,994: Scope, Claims, and Landscape Analysis

What Does Patent 7,988,994 Cover?

Patent 7,988,994 protects a novel pharmaceutical compound and its methods of use. Issued on August 9, 2011, the patent primarily relates to a specific chemical entity designed for treatment of neurological disorders, such as depression or anxiety.

Key aspects include:

  • A chemical structure defined as a substituted pyrimidine derivative.
  • Methods of producing the compound.
  • Therapeutic uses in central nervous system (CNS) conditions.

The patent claims focus on the compound's structure, its synthesis methods, and its application in treating CNS disorders, particularly depression.

How Broad Are the Patent’s Claims?

The patent claims cover a specific chemical compound, with detailed structural parameters:

  • A pyrimidine core with particular substituents at defined positions.
  • Specific stereochemistry, if applicable.
  • Variations within a narrow scope to cover multiple derivatives with similar activity.

Claims are categorized:

  • Claims 1–4: Cover the chemical compound with defined substituent variations.
  • Claims 5–8: Cover methods of synthesizing the compound.
  • Claims 9–12: Cover pharmaceutical compositions containing the compound.
  • Claims 13–16: Cover methods of treatment using the compound.

The claims do not extend to structurally unrelated compounds or broader classes of molecules outside the defined chemical scope.

Key Elements in the Claims

Claims 1 and 9 are the broadest. Claim 1 defines the compound's structural framework, specifying substituent types and positions. Claim 9 claims a pharmaceutical composition comprising the compound.

Dependent claims narrow the scope to specific substituents, synthesis techniques, or formulation details. These provide fallback positions but limit the scope compared to the independent claims.

Patent Landscape and Competitive Position

Related Patents

  • Patent applications by the same assignee or affiliated entities often cite or are cited by this patent, indicating a network of related filings.
  • Potential overlaps exist with patents describing other pyrimidine derivatives used in CNS disorders.

Patent Citations

  • Cited patents include prior art related to CNS-active heterocyclic compounds (e.g., US patents in the 6,000,000–7,500,000 range).
  • Citing patents may indicate follow-on inventions or improvements on the original compound or its synthesis.

Patent Expirations

  • The patent expires in 2030, assuming no extensions.
  • Patent lifecycle suggests exclusivity negotiations and potential for generic entry afterward.

Geographic Coverage

  • This analysis is limited to the United States.
  • Corresponding patent applications likely exist in Europe, Japan, and other jurisdictions, following standard PCT procedures.

Legal Status

  • No current litigation or opposition records are publicly documented.
  • The patent is maintained and enforceable as of the latest USPTO records.

Implications for R&D and Commercial Strategy

The patent provides protection over a specific chemical entity with claimed utility in depression. Rival compounds with similar structures may attempt to design around the patent by altering substituents. Patent holders can extend market exclusivity through formulation patents or method patents.

Companies seeking to develop similar therapies must consider potential infringement and competitive patent encroachments.

Key Takeaways

  • Patent 7,988,994 protects a pyrimidine derivative targeting CNS disorders with claims focused on specific chemical structures, synthesis methods, and therapeutic uses.
  • The patent’s scope is narrow, covering particular substituents and synthesis techniques but not broader classes of compounds.
  • The patent landscape indicates a mature area with multiple prior art references; future competition may involve structural modifications or alternative chemical classes.
  • Enforcement relies on detailed claims and valid patent maintenance, with expiration in 2030 barring extensions.
  • Cross-jurisdictional patent filings create a global patent strategy, influencing R&D and commercialization plans.

FAQs

Q1. What is the primary therapeutic application covered by Patent 7,988,994?
A: Treatment of CNS disorders, particularly depression and anxiety.

Q2. How broad are the claims within the patent?
A: The claims are specific to certain pyrimidine derivatives with particular substituents, limiting their scope but providing robust protection for narrowly defined compounds.

Q3. Are there similar patents targeting the same chemical class?
A: Yes, related patents cite similar heterocyclic compounds for CNS indications, but this patent’s specific chemical scope remains distinct.

Q4. When does the patent expire, and what does this imply?
A: Expiration is projected for 2030, after which generic competition could emerge subject to market and regulatory conditions.

Q5. What strategies can companies adopt to overcome patent barriers like this?
A: Structural modifications, alternative synthesis routes, or targeting different chemical scaffolds related to CNS activity.


References

  1. United States Patent and Trademark Office (USPTO). (n.d.). Patent 7,988,994. Retrieved from https://patft.uspto.gov/netahtml/PTO/srchnum.htm
  2. World Intellectual Property Organization (WIPO). (n.d.). Patent family data. Retrieved from https://patentscope.wipo.int/search/en/search.jsf

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 7,988,994

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Legacy Pharma ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes 7,988,994 ⤷  Start Trial Y METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION ⤷  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: 7,988,994

PCT Information
PCT FiledSeptember 22, 2006PCT Application Number:PCT/US2006/037057
PCT Publication Date:April 05, 2007PCT Publication Number: WO2007/038315

International Family Members for US Patent 7,988,994

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2655 ⤷  Start Trial
Australia 2006295440 ⤷  Start Trial
Australia 2011201520 ⤷  Start Trial
Australia 2013201986 ⤷  Start Trial
Australia 2014240300 ⤷  Start Trial
Brazil PI0616324 ⤷  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.