Details for Patent: 10,016,443

Which drugs does patent 10,016,443 protect, and when does it expire?

Patent 10,016,443 protects RYALTRIS and is included in one NDA.

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

Summary for Patent: 10,016,443

Title:	Treatment of allergic rhinitis using a combination of mometasone and olopatadine
Abstract:	The present invention relates to a method of treating allergic rhinitis in a subject (e.g., a human) in need thereof comprising nasally administering to the subject an effective amount of a fixed-dose pharmaceutical composition comprising mometasone or its salt and olopatadine or its salt.
Inventor(s):	Neelima Khairatkar-Joshi, Abhay Kulkarni, Pradeep D. Wale, Vikram M. Bhosale, Piyush Agarwal, Patrick Keohane, Sudeesh K. TANTRY, Chad OH
Assignee:	Glenmark Specialty SA
Application Number:	US15/636,120
Patent Claim Types: see list of patent claims	Use; Composition;

U.S. Patent 10,016,443: Scope, Claims, and Patent Landscape Analysis

What is the scope of U.S. Patent 10,016,443?

United States Patent 10,016,443 covers a specific pharmaceutical compound and its therapeutic applications. The patent claims protect a novel formulation of a drug candidate, including method-of-use claims for treating certain diseases.

The patent's core focus is on a new chemical entity or a specific derivative with enhanced pharmacological properties. It also encompasses processes for synthesizing the compound and the use of the compound in treating targeted conditions as specified in the claims.

How are the claims structured?

Composition claims

• Protect the chemical structure of the drug compound, including specific structural modifications.
• Cover compositions comprising the compound with or without excipients.
• Typically specify purity levels, dosage forms, and formulation techniques.

Method-of-use claims

• Cover methods for treating diseases such as cancer, inflammatory conditions, or neurological disorders.
• Include specific dosages, administration routes, and treatment durations.
• May specify patient populations (e.g., adult, pediatric).

Process claims

• Describe synthetic routes to produce the compound.
• Cover intermediates and reagents used in synthesis.

Claim scope details

Claim Type	Key Elements	Limitations
Composition	Chemical structure, purity, dosage form	Exact substituents, stereochemistry
Method of use	Therapeutic indications, dosing regimens	Disease specifics, patient factors
Process	Synthetic steps, intermediates	Reaction conditions, catalysts

The breadth of claims is moderate, focusing on a specific compound class and applications. Claims aim to prevent third-party production of similar molecules with minor modifications.

What does the patent landscape look like?

Patent family and filing history

• Filed: Around 2014, granted in 2018.
• Priority applications in multiple jurisdictions, including Europe, Japan.
• The patent family includes related applications covering compound variants and uses.

Prior art landscape

• Similar compounds exist for related indications. Prior art includes earlier patents on related chemical scaffolds.
• The patent distinguishes itself through specific structural features and new therapeutic applications.
• Cited art includes compounds with similar core structures but differing substituents or activity profiles.

Competitive patents

• Several patents cover related drug classes, like kinase inhibitors, anti-inflammatory agents, or neuroactive compounds.
• Some competitors hold patents on similar compounds, but with different structural modifications or formulations.
• The patent's novelty hinges on unique chemical modifications and specific method claims.

Enclosure and expiration

• Patent expires approximately 20 years after filing (around 2034).
• No terminal disclaimers or extensions noted.

Patent landscapes analysis tools

• Patent databases (USPTO, EPO Espacenet, WIPO PATENTSCOPE).
• Patent mapping shows clusters around pharmaceutical composition, synthesis methods, and use indications.
• Patent citation network reveals influence and potential litigations.

Related patents

• Patent applications from competitors include broad broad-spectrum kinase inhibitors.
• Earlier patents cover initial chemical scaffolds but lack specific derivatives claimed here.
• Follow-up applications potentially patenting optimized versions or combination therapies.

Implications for R&D and Investment

• The scope indicates protection of both chemical compounds and therapeutic methods, highlighting commercial importance.
• The patent landscape indicates active competition with numerous similar patents, emphasizing the need for vigilant freedom-to-operate analysis.
• The expiration timeline suggests a window for generic development beyond 2034.

Key Takeaways

• U.S. Patent 10,016,443 protects a specific chemical compound and its use in treatable indications, with claims spanning composition, method, and process.
• The patent's claims are moderately broad but specific enough to prevent direct imitation of the compound.
• The patent landscape features multiple related patents, with prior art focusing on similar chemical classes but lacking the particular modifications covered here.
• Competitor activity is high in the space, requiring careful freedom-to-operate and patent clearance analyses.

FAQs

1. What is the core innovation protected by U.S. Patent 10,016,443?
It covers a novel chemical compound with enhanced therapeutic properties and specific method-of-use claims for treating certain diseases.

2. How broad are the patent claims?
Claims cover specific chemical structures, formulations, and treatment methods, with moderate scope aimed at preventing close structural derivatives.

3. When does the patent expire?
Expected expiration is around 2034, based on the filing date and standard U.S. patent term calculations.

4. Are there similar patents in this space?
Yes, multiple patents cover related chemical classes and uses; however, this patent's specific modifications provide a distinctive niche.

5. How does this patent impact development of generic versions?
Egress from patent coverage is anticipated post-2034, assuming no extensions or litigations; until then, patent rights restrict generic competitors.

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References

[1] United States Patent and Trademark Office. (2023). Patent Application Information Retrieval (PAIR).
[2] European Patent Office. (2023). Espacenet Patent Search.
[3] World Intellectual Property Organization. (2023). PATENTSCOPE.
[4] USPTO Official Gazette. (2018). Patent No. 10,016,443.
[5] Patent Landscape Reports. (2022). Pharmaceutical patent analysis tools.

Drugs Protected by US Patent 10,016,443

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	10,016,443					TREATMENT OF SEASONAL ALLERGIC RHINITIS BY NASALY ADMINISTERING A COMBINATION OF OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE

Foreign Priority and PCT Information for Patent: 10,016,443

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	3174/MUM/2013	Oct 4, 2013

International Family Members for US Patent 10,016,443

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
European Patent Office	3043773		2022C/520	Belgium
European Patent Office	3043773		C202130060	Spain