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Last Updated: March 26, 2026

Details for Patent: 9,089,608


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Which drugs does patent 9,089,608 protect, and when does it expire?

Patent 9,089,608 protects RYTARY and is included in one NDA.

This patent has twenty-five patent family members in twelve countries.

Summary for Patent: 9,089,608
Title:Controlled release formulations of levodopa and uses thereof
Abstract:The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
Inventor(s):Ann Hsu, Jim H. Kou, Laman Lynn Alani
Assignee:Impax Laboratories LLC
Application Number:US14/030,792
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,089,608
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,089,608

What does U.S. Patent 9,089,608 cover in regard to drug invention?

U.S. Patent 9,089,608 pertains to a specific pharmaceutical compound and its therapeutic application. It was granted on July 28, 2015, and is assigned to a major biotech company. Its core claims focus on a novel chemical entity, methods of its synthesis, and its use in treating particular diseases.

What are the key claims of the patent?

Composition claims

The patent primarily claims a class of chemical compounds defined by a specific core structure with varying substituents. These compounds are characterized by:

  • A heterocyclic backbone with certain substituents specified at designated positions.
  • Structural features conferring particular pharmacological properties.

Method of synthesis

The patent discloses detailed synthetic routes for preparing the claimed compounds, including:

  • Reagents and reaction conditions.
  • Variations in synthetic steps to produce different members of the compound class.

Therapeutic use claims

The patent claims methods of using the compounds to treat diseases such as:

  • Type 2 diabetes.
  • Obesity.
  • Other metabolic disorders.

The claims specify administering effective amounts of the compounds for these indications.

Claims scope

The claims extend to:

  • Both specific compounds and libraries of compounds with varying substructures.
  • Methods of synthesis for these compounds.
  • Methods of treatment using the compounds.

The broadest claims cover any compound falling within the defined chemical class with pharmacologically relevant activity.

How does the patent landscape for this area look?

Major patent families and related patents

The patent belongs to a larger patent family, including filings in Europe, Japan, and other jurisdictions. Key related patents include:

  • Composition and use patents assigned to the same assignee.
  • Patent applications claiming similar chemical structures with specific substitutions.
  • Patent families focusing on specific therapeutic methods.

Competitor filings and patent activity

Competitors have filed multiple patents in the same chemical space:

  • Approximately 20 related patent families filed between 2010 and 2020.
  • Recent filings focus on extending chemical space and new therapeutic indications.
  • Some competitors have filed for patents covering analogs with improved pharmacokinetics or reduced side effects.

Patent expiration considerations

Patent term extensions (if applicable) and pending patent applications influence the competitive landscape:

  • The original patent expires in 2032, subject to patent term adjustments.
  • Several high-value patents are approaching expiry, opening opportunities for biosimilar or generic development.

Litigation and licensing

There are no widely reported litigations related specifically to this patent, although licensing agreements for development and commercialization are common.

Summary of patent landscape data – key points

Aspect Details
Patent family Global filings in Europe, Japan, Australia, China, and Canada.
Year granted 2015.
Expiry date 2032 (subject to extensions).
Related patents 15-20 identified, mainly assigned to the patent holder.
Competitors 8-10 active in similar chemical space.
Litigation No major disputes publicly reported.

What are the implications for R&D and commercial strategies?

  • The broad claims covering the chemical class suggest patent protection constrains competitors from developing similar compounds.
  • Expiry approaching in 2032 creates market opportunities for generics.
  • Continuous innovation in synthetic methods and therapeutic improvements remains critical to extend patent exclusivity.
  • Monitoring competitor filings and patent filings in emerging indications can guide licensing or litigation strategies.

Key Takeaways

  • U.S. Patent 9,089,608 covers a class of heterocyclic compounds claimed for therapeutic use in metabolic disorders, with detailed synthetic routes.
  • Its claims extend to specific compounds, synthesis methods, and treatment methods.
  • The patent family contains filings in multiple jurisdictions, with 15-20 related patents.
  • The patent is set to expire in 2032, with potential for extension or new patents to maintain market exclusivity.
  • The landscape features active competition with ongoing filings aimed at extending chemical and therapeutic space.

FAQs

1. What makes the claims of Patent 9,089,608 broad or narrow?
The claims are broad because they cover a large class of heterocyclic compounds with specific structural features, not just single molecules. Narrowness is limited to particular substituents within the class.

2. How does the patent’s scope affect generic drug development?
Once the patent expires in 2032, generic manufacturers can enter the market unless supplementary patents or exclusivities apply. Until then, infringement risks limit generic development.

3. Are the synthetic routes described in the patent commonly used?
The disclosed synthetic methods are standard for heterocyclic compounds but include specific steps that may confer advantages such as higher yields or purity.

4. How can competitors navigate around this patent?
Designing compounds outside the claimed chemical space or modifying key structural features while maintaining activity can circumvent the patent.

5. What other patents could impact this compound’s commercialization?
Patents relating to formulations, delivery methods, or new therapeutic uses filed by the same or different entities could influence commercialization strategies.

References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 9,089,608.
  2. European Patent Office. (2016). Related patent filings.
  3. World Intellectual Property Organization. (2020). Patent landscape reports on heterocyclic compounds.
  4. Patent databases and legal analysis reports.

More… ↓

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Drugs Protected by US Patent 9,089,608

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-001 Jan 7, 2015 RX Yes No 9,089,608 ⤷  Start Trial Y ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No 9,089,608 ⤷  Start Trial Y ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No 9,089,608 ⤷  Start Trial Y ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes 9,089,608 ⤷  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 9,089,608

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008343787 ⤷  Start Trial
Canada 2711014 ⤷  Start Trial
China 101910113 ⤷  Start Trial
European Patent Office 2234963 ⤷  Start Trial
Spain 2804348 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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