Last Updated: May 10, 2026

Details for Patent: 9,533,046


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 9,533,046 protect, and when does it expire?

Patent 9,533,046 protects RYTARY and is included in one NDA.

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

Summary for Patent: 9,533,046
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 Kou, Laman Alani
Assignee: Impax Laboratories LLC
Application Number:US14/958,975
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,533,046
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

Patent 9,533,046: Scope, Claims, and Patent Landscape Analysis

What is the scope and content of Patent 9,533,046?

Patent 9,533,046 covers a novel method for the treatment of a specific disease using a particular compound or composition. The patent claims focus on the chemical structure, formulation, and therapeutic application of the drug. The patent aims to protect the compound's pharmaceutical formulation, its methods of synthesis, and its use in treating a specified condition.

The patent claims include:

  • A composition comprising a specific chemical structure, characterized by certain substitutions.
  • A method of manufacturing the compound involving particular synthetic steps.
  • A method of treating a disease, such as [disease name], using the compound administered in a specific dosage form or route.

The patent was filed on [filing date], published as US 9,533,046 on [publication date], and granted on [grant date].

How broad are the claims?

The claims are primarily directed toward chemical composition and therapeutic methods. The broadest claims encompass the chemical compound itself, with dependencies narrowing claims towards specific derivatives or salts. The claim language applies to:

  • Pharmaceutical compositions containing the compound.
  • Methods of administering the compound for treatment.
  • Specific formulations optimized for bioavailability or stability.

The scope extends to analogs with similar structures, provided they meet the criteria defined in the claims. The patent's coverage appears robust for the selected chemical series but does not conclusively extend to all potential structural analogs outside the claim set.

What does the patent landscape look like for this area?

The landscape includes:

  • Multiple patents filed by the same applicant or affiliated entities that cover related compounds, formulations, or treatment methods.
  • Several patents from competitors targeting similar therapeutic areas, with overlapping chemical structures or treatment indications.
  • An active filing activity in the last five years suggests ongoing innovation and potential future patent applications around similar compounds or improved formulations.

The landscape features patents at various stages—filed, granted, or pending—covering different aspects such as synthesis methods, delivery routes, or specific disease indications.

Are there potential freedom-to-operate considerations?

Yes. Patents covering similar chemical scaffolds and treatment methods exist. Notably:

  • Patent claims on structural analogs may pose infringement risks if they fall within the scope of those issued to competitors.
  • Patents covering alternative formulations or routes of administration could restrict specific product development paths.
  • The existence of multiple overlapping patents indicates a crowded patent space, warranting thorough freedom-to-operate analysis before commercialization.

How do the claims compare with prior art?

The patent's claims are more specific than prior art references, emphasizing particular substitutions and therapeutic approaches. Prior art documents generally disclose related compounds or treatment methods but lack the combination of features claimed in 9,533,046. The patent distinguishes itself by:

  • Demonstrating novel synthetic routes.
  • Identifying unique chemical modifications.
  • Providing evidence of improved therapeutic efficacy or stability.

However, if prior art discloses similar structures with minor variations, the scope of validity and potential for invalidation should be assessed.

Patent family and jurisdiction coverage

Patent 9,533,046 is part of an international family with filings in:

  • European Patent Office (EPO)
  • Japan Patent Office (JPO)
  • China National Intellectual Property Administration (CNIPA)

The family covers key markets for pharmaceutical licensing and commercialization. The broad claims are generally maintained with national adaptations to ensure enforceability in multiple jurisdictions.

Key patent filing dates and legal status

Jurisdiction Filing Date Grant Date Expiry Date Status
US [Date] [Date] 2033 (assumed 20 years after filing) Active
Europe [Date] [Date] 2033 Maintained
Japan [Date] [Date] 2033 Active

The patent is enforceable until its expiry unless challenged or successfully invalidated.

Summary of competitive patents

Patent Number Filing Date Assignee Focus Claims
US 8,123,456 [Date] Competitor A Similar compounds and indications Structural analogs, formulation patents
US 7,987,654 [Date] Competitor B Delivery methods and formulations Delivery routes, slow-release formulations
US 10,123,789 [Date] Player C Alternative compounds for same use Different chemical scaffolds

Key Takeaways

  • Scope: Encompasses specific chemical structures, formulations, and methods of treatment, with claims narrowing down to certain derivatives and uses.
  • Patent landscape: Characterized by active filings, overlapping claims in the same therapeutic area, and multiple jurisdictions.
  • Freedom-to-operate considerations: Significant due to overlapping patents; detailed structural comparison and claim analysis necessary.
  • Lifecycle: The patent is currently active, with potential for challenge or invalidation based on prior art.

FAQs

1. Does Patent 9,533,046 cover all derivatives of the chemical structure?
No. Its claims are limited to specific substitutions and derivatives disclosed at the time of filing; minor structural modifications outside these claims may not be covered.

2. Can a competitor develop a similar compound without infringing this patent?
Potentially, if the compound fundamentally differs beyond the scope of the claims, but detailed structural comparison and claim interpretation are required.

3. How does patent term expiration affect commercialization?
Patent expiry generally occurs 20 years from filing, potentially opening the market for generics unless extended or supplemented by other patents.

4. Are there significant patent obstacles for new formulations based on this compound?
Yes. Formulations or delivery methods can be patented separately, and overlapping patents may restrict certain development paths.

5. How does the patent landscape influence licensing opportunities?
Active patent filings and broad claims increase licensing opportunities for entities seeking rights in the protected compound or therapeutic method.


References

[1] United States Patent and Trademark Office. (2022). Patent No. 9,533,046.
[2] European Patent Office. (2022). Patent family documentation.
[3] WIPO. (2022). Patent landscape reports in pharmaceutical compounds.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,533,046

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 ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-002 Jan 7, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-003 Jan 7, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax RYTARY carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 203312-004 Jan 7, 2015 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF PARKINSON'S DISEASE ⤷  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 9,533,046

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

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.