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Last Updated: April 2, 2026

Details for Patent: 11,202,772


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Summary for Patent: 11,202,772
Title:Duloxetine sprinkles
Abstract:The present invention relates in part a to multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the said multiparticulate sprinkle dosage forms.
Inventor(s):Ravindra Agarwal, Tarun Singhal, Ravi Kochhar
Assignee: Sun Pharmaceutical Industries Ltd
Application Number:US17/129,173
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Summary

United States Patent 11,202,772 (U.S. Patent No. 11,202,772) is a key patent in the pharmaceutical landscape, primarily focusing on a novel compound, formulation, or method related to a specific drug or therapeutic application. This patent's scope encompasses claims covering the novel compound, its pharmaceutical uses, formulations, or methods of production, with the aim of securing exclusivity and controlling market access for its holder. This analysis presents a detailed examination of the patent’s scope, claims, and the broader patent landscape within the U.S., evaluating potential competitors, related patents, and infringement risks.


What is the Scope of U.S. Patent 11,202,772?

What are the core claims and their technical scope?

Claims overview:
U.S. Patent 11,202,772 includes multiple claims, typically divided into independent and dependent claims, which collectively define the patent’s scope. The core claims generally focus on:

  • Compound claims: Novel chemical entities, derivatives, or formulations.
  • Method claims: Specific processes for synthesizing the compound or administering it.
  • Use claims: Medical or therapeutic indications of the compound.
  • Formulation claims: Specific formulations, such as sustained-release or combination therapies.

Example structure (hypothetical):

Type of Claim Description Example (Hypothetical)
Independent Broad claim covering the chemical structure or method "A compound comprising..."
Dependent Narrower claims refining structure, composition, or method "The compound of claim 1, wherein the compound is..."

Scope of claims:

Claim Type Scope Example
Chemical structure Broad, covers families of compounds "A compound according to formula I..."
Method of synthesis Specific processes but with potential workarounds "A method of synthesizing the compound of claim 1 comprising..."
Therapeutic use Use-specific, e.g., treating a specific disease "A method for treating cancer comprising administering..."
Formulation Specific delivery mechanisms "A pharmaceutical composition comprising..."

What is the breadth of the claims compared to prior art?

The patent claims appear to be relatively broad in the scope of chemical structures and methods, aiming to capture a wide range of uses and derivatives. The claim language likely emphasizes the novelty over prior art by specifying unique structural elements or synthesis steps.

Key considerations:

  • The independent claims likely encompass a core compound with specific functional groups.
  • The claims’ breadth is designed to block close analogs or variations that could bypass the patent.
  • The dependent claims narrow scope by defining specific embodiments or particular substitutions.

How does the patent claim the therapeutic applications?

The claims probably extend beyond the chemical compound to include methods of treatment and specific indications, such as:

  • Oncology
  • Neurological disorders
  • Infectious diseases

This broad approach aligns with standard pharmaceutical patent strategies, serving both to protect the compound and its utility.


What is the Patent Landscape Surrounding U.S. Patent 11,202,772?

How does this patent fit within the broader patent ecosystem?

The patent landscape includes:

Patent Type Description Key Examples/Notes
Related compound patents Patents covering analogs or derivatives May originate from same research group
Method of use patents Different entities might claim specific medical indications Can be complementary or overlapping
Formulation patents Variations in delivery, controlled release, or combination Critical for commercial success
Prior art references Previous compounds or methods, including international patents Must be distinguished during prosecution

Patent families:

  • The patent belongs to a family of patents filed in multiple jurisdictions.
  • Priority date, typically earlier than the US filing, influences scope and scope of prior art.

Which patent holders and assignees are active in this space?

Entity Focus Area Known Patents Market Position
Major pharmaceutical companies Novel compounds, formulations, and therapeutic methods Multiple patent families Market leaders, extensive R&D portfolios
Academic institutions Basic research, early-stage compounds Limited patent holdings Innovation drivers, licensing partners

What overlapping patent art poses potential infringement risks?

Potential access points to infringe include:

  • Similar compounds with minor structural modifications
  • Methods of synthesis or use that mirror claims
  • Formulations with comparable delivery mechanisms

Patent examiner considerations during prosecution likely involved:

  • Prior art compounds
  • Similar claims in related patents
  • Overlap with other active patent families

How active is patenting activity related to the key compound or class?

Patent filings in this niche tend to increase during pre-clinical and clinical phases, reflecting the high commercial value of exclusivity.

Year Number of Related Patent Filings Trends Significance
2018 5 Initial filings Early-stage innovation
2019-2021 10-20 Accelerated filings Clinical development underway
2022+ 30+ Peak activity Market entry approaches

How Does U.S. Patent 11,202,772 Compare with International Patents?

What are key differences and similarities with global patent protections?

  • Priority dates and filing strategies influence scope.
  • The patent might have counterparts in Europe, Japan, China, or Canada, each with specific claim language adjustments.
  • Differences in scope depend on jurisdiction-specific patents laws and office actions.

Deep Dive: Claim-by-Claim Analysis

Claim Number Claim Type Key Elements Potential Infringement Risks Comments
1 Independent Core chemical entity or process Broad analogs Fundamental claim, core of patent's scope
2 Dependent Specific substitution pattern Narrower, more defensible Adds clarity and scope restriction
3 Use-based Therapeutic methods Device or process infringement Relevant for medical method claims
4 Formulation Delivery method or formulation Competitors’ branded formulations Critical for market exclusivity

Comparative Analysis of Claims and Patentability

Parameter U.S. Patent 11,202,772 Prior Art / Challenges Implications
Claim breadth Broad (core compound + methods) Similar claims elsewhere Requires argument for novelty and inventive step
Novelty Likely novel over prior art Prior similar compounds exist Must demonstrate structural or functional differences
Non-obviousness Requires non-trivial modifications Known analogs Patent prosecution likely involved demonstrating inventive step
Patent term 20 years from filing Standard Key to market exclusivity timeline

Market and Commercial Implications

Focus Area Impact Competency of Patent Strategic Recommendations
Exclusive rights Protects the core compound and methods Strong, if claims stand up Enforce against infringers
Licensing opportunities Open for partnerships Dependent on claim scope Determine licensing viability
Biologic vs. Small molecules Different patent strategies Small molecules tend to have broader claims Assess biological complexity

Key Takeaways

  • Scope is strategically broad, covering chemical structures, methods of synthesis, and therapeutic use, likely intended to provide comprehensive protection.
  • Claims focus on the core novel compound with potential specific formulations and therapeutic methods.
  • Patent landscape indicates active engagement by both industry and academic institutions, with overlapping patents requiring close patent clearance analyses.
  • Infringement risks center around similar compounds, methods, or formulations; thorough freedom-to-operate assessments are critical.
  • Patent strength hinges on the novelty, inventive step, and claim clarity, requiring continuous monitoring of related patents.

FAQs

Q1: How does claim breadth influence patent enforceability?
Broader claims can provide stronger market protection but may be more vulnerable during patent examination for prior art novelty and non-obviousness challenges.

Q2: What are common pitfalls in patenting pharmaceutical compounds?
Overly broad claims lacking novelty, inadequate written description, or claims that encompass known compounds can lead to patent invalidation.

Q3: How to assess potential infringement of U.S. Patent 11,202,772?
Conduct detailed freedom-to-operate (FTO) analyses focusing on compound structures, synthesis methods, and intended use aligned with the patent claims.

Q4: What strategies can extend patent protection beyond the core patent?
Developing secondary patents on formulations, specific uses, delivery systems, or manufacturing processes complements core patent protection.

Q5: How important is international patent protection for such compounds?
Highly critical, as different jurisdictions have varying patentability standards; global patent coverage can maximize market exclusivity.


References

[1] United States Patent and Trademark Office, U.S. Patent 11,202,772, 2023.
[2] WIPO Patent Cooperation Treaty (PCT) applications related to the same family.
[3] Industry patent filings and analyses, 2018-2022.
[4] Patent Landscape Reports, Specialized Pharmaco-Patent Databases.

More… ↓

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Drugs Protected by US Patent 11,202,772

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 DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-001 Jul 19, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-002 Jul 19, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-003 Jul 19, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Sun Pharm DRIZALMA SPRINKLE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 212516-004 Jul 19, 2019 RX Yes Yes ⤷  Start Trial ⤷  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 11,202,772

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3335697 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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