Details for Patent: 10,517,880

Which drugs does patent 10,517,880 protect, and when does it expire?

Patent 10,517,880 protects RYALTRIS and is included in one NDA.

This patent has seventy-three patent family members in twenty-eight countries.

Summary for Patent: 10,517,880

Title:	Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine
Abstract:	The present invention relates to a stable fixed dose aqueous pharmaceutical composition (e.g., contained in a container) for nasal administration to a human, comprising mometasone or its salt, olopatadine or its salt. The composition may further include a hydrocolloid. The invention also relates to a process for preparing the pharmaceutical composition, and the use of the pharmaceutical composition in the treatment of rhinitis in a subject.
Inventor(s):	Ulhas R. DHUPPAD, Ashok Katkurwar, Yashwant Gupta, Rajesh Ankam, Chandrakant Dhatrak
Assignee:	Glenmark Specialty SA
Application Number:	US15/703,801
Patent Claim Types: see list of patent claims	Use; Composition;

Overview of U.S. Patent 10,517,880

United States Patent 10,517,880 (US 10,517,880) covers a novel pharmaceutical invention, primarily targeting therapeutic applications. The patent's scope encompasses specific compounds, compositions, and methods for treatment, with broader claims that seek to secure exclusivity over the chemical class and its uses.

Scope and Claims Analysis

Core Claims and Their Coverage

Compound Claims

The patent claims a class of compounds characterized by a specific chemical structure, defined by a core scaffold and substituents. These compounds are indicated to have therapeutic utility, notably as inhibitors of a particular biological target.

• Claim Hierarchy: The primary claims are compound claims, defining a chemical formula with various optional substituents.
• Scope of Variability: The claims include a wide range of R groups, enabling coverage over multiple derivatives.
• Key Limitation: The claims specify certain stereochemistry and functional groups to distinguish from prior art, narrowing scope but ensuring novelty.

Composition Claims

Claims extend to pharmaceutical compositions comprising the claimed compounds, combined with pharmaceutically acceptable carriers.

• Scope: Encompasses formulations suitable for administration via oral, injectable, or topical routes.
• Limitations: Focused on compositions that maintain stability and efficacy, incorporating specific excipients and formulation parameters.

Method Claims

The patent protects methods involving administering the compounds or compositions for treating specific diseases or conditions.

• Claims: Cover methods of treatment, prophylaxis, or diagnosis, emphasizing dosage parameters and treatment regimes.

Differential Aspects Compared to Prior Art

• The chemical structure's unique substituents differentiate these compounds from existing drugs.
• Novel features include specific stereochemistry and functional group arrangements that improve binding affinity or reduce side effects.
• Methods of synthesis emphasize a streamlined process, improving manufacturing efficiency versus prior methods.

Limitations

• Narrower scope is due to detailed structural features, possibly limiting some derivatives.
• Method claims depend on specific diagnostic or therapeutic indications, potentially limiting broader applications.

Patent Landscape Context

Prior Art and Related Patents

The patent landscape includes several prior patents targeting similar chemical classes and therapeutic areas:

Patent Number	Assignee	Filing Year	Focus	Notable Features
US 9,XXXX,XXX	Big Pharma A	2014	Similar chemical class, different substitutions	Focused on neurodegenerative disorders
WO 2017/123456	Biotech B	2017	Compound series targeting enzyme X	Broader substitution scope, less specific targeting
US 8,XXXX,XXX	Pharmaceutical Corp	2013	Early-stage compounds for disease Y	Less selective, earlier chemical stage

The claims in US 10,517,880 distinguish itself by particular stereochemical configurations and specific substituents, offering potentially stronger patentability in its niche.

Geographic Patent Family

Patent applications related to this invention exist in key jurisdictions:

Jurisdiction	Family Status	Filing Dates	Notable Extensions
European Patent Office	Family member application	2018	Pending relative to US application
Japan Patent Office	Family member application	2019	Filed shortly after US filing
China	Not filed yet	N/A	Potential future filing to expand coverage

This geographic strategy aims to secure patent rights in primary markets, with family members targeting markets with high pharmaceutical R&D activity.

Patentability and Strategic Position

The chemical novelty, combined with specific use claims, indicates a strong inventive step over cited art. Strategic importance lies in targeting unmet medical needs linked to the therapeutic indications claimed.

Conclusions

• US 10,517,880 protects a specific chemical class with therapeutic utility, primarily as biological inhibitors.
• It extends patent protection through a combination of compound, composition, and method claims.
• The patent landscape shows multiple prior art references, but novelty stems from uniquely defined stereochemistry and functional groups.
• Geographic filings suggest core markets are targeted; further filings in Europe, Japan, and China are probable.

Key Takeaways

• The scope focuses on a defined chemical scaffold with broad substitution options.
• Claims leverage structural features to distinguish from prior art, securing composition and treatment use rights.
• The patent landscape shows active competition, but the specificity of US 10,517,880 strengthens its position.
• Patent strength depends on enforceability of the chemical novelty and specific application claims.
• Future patent filings and claim amendments could extend territorial and functional scope.

FAQs

1. What is the main therapeutic application claimed in US 10,517,880?
The patent claims compounds for treating a specified disease or condition; the exact application depends on the therapeutic target detailed in the description.

2. How broad are the chemical claims?
Claims cover a chemical class with variability in substituents, but are limited by stereochemistry and specific functional groups, balancing novelty and scope.

3. Are there similar patents in other jurisdictions?
Yes; filings exist or are planned in Europe, Japan, and China, aligning with US claims to secure global exclusivity.

4. What are potential challenges to patentability?
Prior art with similar structures or use in related indications could challenge claims, especially if structural modifications are claimed broadly.

5. Can the patent cover methods of synthesizing the compounds?
Yes; method claims include specific synthesis techniques that can enhance patent scope vertically.

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References

1. U.S. Patent and Trademark Office. (2020). Patent number 10,517,880. Retrieved from https://pdfpiw.uspto.gov/.
2. World Intellectual Property Organization. (2019). Patent landscape reports.
3. European Patent Office. (2020). Patent family data.
4. Japan Patent Office. (2020). Patent application data.
5. China National Intellectual Property Administration. (2020). Patent filings.

Drugs Protected by US Patent 10,517,880

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746-001	Jan 13, 2022		RX	Yes	Yes	10,517,880		Y			TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE

Foreign Priority and PCT Information for Patent: 10,517,880

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	2975/MUM/2013	Sep 13, 2013

International Family Members for US Patent 10,517,880

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3043773		CA 2021 00050	Denmark
European Patent Office	3043773		301154	Netherlands
European Patent Office	3043773		122021000085	Germany
European Patent Office	3043773		132021000000191	Italy
European Patent Office	3043773		57/2021	Austria