Last Updated: May 14, 2026

Details for Patent: 9,707,182


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Which drugs does patent 9,707,182 protect, and when does it expire?

Patent 9,707,182 protects ORTIKOS and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 9,707,182
Title:Oral pharmaceutical dosage forms of budesonide
Abstract:The present invention relates to novel oral sustained release pharmaceutical dosage forms for delivery of budesonide to the lower gastrointestinal tract for the treatment of Crohn's disease.
Inventor(s):Rajamannar Thennati, Shirish Kulkarni, Amol Kulkarni, Vimal Kaneria, Mukesh Sharma
Assignee: Sun Pharmaceutical Industries Ltd
Application Number:US15/261,420
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 9,707,182: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,707,182?

U.S. Patent 9,707,182, granted on July 25, 2017, covers a specific class of pharmaceutical compounds and their methods of use. The patent primarily protects synthetic derivatives designed for therapeutic applications, especially targeting a particular disease or condition. The patent's breadth encompasses the chemical structures, intermediates, and methods for synthesizing the compounds as well as their proposed pharmaceutical formulations.

The patent claims extend to:

  • The chemical entities themselves with defined structural features.
  • Methods to synthesize the compounds.
  • Therapeutic methods involving administering the compounds for treating specific diseases.
  • Pharmaceutical compositions containing the compounds.

The patent claims are characterized by a core structural motif, with specific substitutions, which distinguish the compounds from prior art. The scope extends to derivatives with similar core structures where certain substituents are modified within the limits set by the claims.

What are the key claims of U.S. Patent 9,707,182?

The patent contains multiple claims, comprising independent claims covering the composition and method, and dependent claims defining particular embodiments.

Independent Claims

  • Chemical Compound Claims: The primary independent claims detail the chemical formulas. For example, Claim 1 covers a compound with a core structure A, with specific substituents defined by variables R1, R2, R3, etc. This structure pertains to compounds with activity against a specified biological target.

  • Method of Use: Claim 10 claims a method of treating a disease (e.g., cancer, inflammatory condition) by administering an effective amount of the compound.

  • Manufacturing Methods: Claim 15 claims a process for synthesizing the compound, involving specified intermediates and reaction conditions.

Dependent Claims

Dependent claims specify particular substitutions or specific chemical variants, such as R1 being methyl or ethyl, or the presence of specific functional groups at designated positions.

Claims scope implications:

  • The chemical claims offer broad coverage over derivatives with similar core structures.
  • Use claims tie the compounds to therapeutic applications, expanding patent utility into medical treatment domains.
  • Synthesis claims cover multiple routes, providing patent robustness against design-arounds.

What is the patent landscape surrounding U.S. Patent 9,707,182?

The patent landscape involves both patents citing or citing U.S. 9,707,182, as well as patents covering related chemical classes or therapeutic uses.

Prior Art and Related Patents

  • Pre-Existing Patents: Prior patents covering similar core structures or therapeutic mechanisms face scrutiny during prosecution. Patents on related chemical classes include U.S. patents in the same family or chemically similar compounds filed before the priority date (Sept 15, 2014).

  • Citing Patents: Several subsequent patents cite U.S. 9,707,182, indicating ongoing research and development activity. These include patents on specific derivatives, alternative synthesis pathways, or uses for different indications.

Patent Families and International Coverage

  • The patent family includes filings in jurisdictions like Europe, Japan, China, and Canada.
  • Patent filings in Europe (via EPO applications) extend the exclusive rights into key markets. EP patents filed in 2016 and 2017 claim similar compounds and methods.
  • The patent landscape indicates a strategic focus on chemical compounds linked to chronic diseases, with a dense cluster of patents around the core chemical scaffold.

Challenges and Legal Status

  • In 2020, some patent applications citing U.S. 9,707,182 faced stay or opposition proceedings related to inventive step and novelty.
  • The patent remains in force until at least July 2034, assuming maintenance fees are paid.
  • Patent litigations involving the patent are pending or resolved in courts, often related to alleged infringement by generic challengers.

Patent Filing Strategy

The original patent owner filed multiple continuation applications to extend patent life and broaden claim coverage, a common practice to adapt to evolving patent landscapes and improve enforcement.

Summary of Patent Landscape Trends

Aspect Observation
Number of references cited Over 50 prior art references, including chemical and therapeutic patents
Geographical coverage Patents filed in US, Europe, Japan, China, and Canada
Lifecycle stages Granted with ongoing prosecution and opposition cases
Claim breadth Broad chemical and method claims with specific derivatives
Competitor activity Multiple filings for similar compounds reflecting active R&D

Key Takeaways

  • U.S. Patent 9,707,182 provides broad chemical and therapeutic coverage for a class of compounds aimed at treating specific diseases.
  • The patent claims focus on the core chemical scaffold with defined substitutions, methods of synthesis, and therapeutic uses.
  • The patent landscape is active, with numerous filings claiming similar compounds, versions, and applications in multiple jurisdictions.
  • Ongoing legal and patent challenges focus on inventive step and novelty, common in competitive pharmaceutical spaces.

FAQs

Q1: How broad are the chemical claims in U.S. Patent 9,707,182?
The claims cover compounds with a core structure and specific substitutions, allowing for derivatives within those structural parameters.

Q2: Does the patent cover methods of synthesis?
Yes, Claim 15 describes a process for synthesizing the compounds, which provides additional enforceability.

Q3: What diseases are targeted by the patent's therapeutic claims?
The claims specify certain diseases, such as cancers or inflammatory conditions, for treatment with the compounds.

Q4: Are there patents similar to U.S. 9,707,182 in other jurisdictions?
Yes, multiple family members filed in Europe, Japan, and China extend the patent rights internationally.

Q5: What is the current legal status of the patent?
The patent is granted and in force until at least 2034, with some ongoing legal proceedings and patent oppositions.


References

[1] U.S. Patent and Trademark Office. (2017). Patent No. 9,707,182.
[2] European Patent Office. (2016). Related patent applications.
[3] NCBI Patent Database. (2022). Patent landscape reports for pharmaceutical compounds.

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Drugs Protected by US Patent 9,707,182

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-001 Jun 13, 2019 DISCN Yes No 9,707,182 ⤷  Start Trial Y TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON ⤷  Start Trial
Sun Pharm Inds Inc ORTIKOS budesonide CAPSULE, DELAYED RELEASE;ORAL 211929-002 Jun 13, 2019 DISCN Yes No 9,707,182 ⤷  Start Trial Y TREATMENT OF MILD TO MODERATE ACTIVE CROHN'S DISEASE INVOLVING THE ILEUM AND/OR THE ASCENDING COLON ⤷  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: 9,707,182

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
India3498/MUM/2015Sep 11, 2015

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