Details for Patent: 10,098,892

Which drugs does patent 10,098,892 protect, and when does it expire?

Patent 10,098,892 protects BELSOMRA and is included in one NDA.

This patent has eighteen patent family members in ten countries.

Summary for Patent: 10,098,892

Title:	Solid dosage formulations of an orexin receptor antagonist
Abstract:	The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant. The concentration-enhancing polymer is a polymer that forms an amorphous dispersion with suvorexant, that is insoluble or almost completely insoluble in water by (a) dissolving the suvorexant or (b) interacting with the suvorexant in such a way that the suvorexant does not form crystals or crystalline domains in the polymer. A concentration-enhancing polymer is water soluble or readily disperse in water, so that when the polymer is placed in water or an aqueous environment (e.g. fluids in the gastrointestinal (GI) tract or simulated GI fluids), the solubility and/or bioavailability of suvorexant is increased over the solubility or bioavailability in the absence of the polymer.
Inventor(s):	Harmon; Paul A. (Audubon, PA), Variankaval; Narayan (Plainsboro, NJ)
Assignee:	Merck Sharp & Dohme Corp. (Rahway, NJ)
Application Number:	14/404,147
Patent Claim Types: see list of patent claims	Composition; Process;

Understanding the Scope and Claims of United States Patent 10,098,892: Solid Dosage Formulations of an Orexin Receptor Antagonist

Introduction to Belsomra and Its Patents

Belsomra, a drug owned by Merck Sharp & Dohme Corp., is an orexin receptor antagonist used primarily for the treatment of insomnia. The drug is protected by several U.S. patents, one of which is the subject of this analysis: United States Patent 10,098,892.

Patent Overview: US 10,098,892

Patent Title and Inventors

The patent titled "Solid dosage formulations of an orexin receptor antagonist" was issued on October 16, 2018. The inventors listed are Harmon Paul A. and Variankaval Narayan, with Merck Sharp & Dohme Corp. as the assignee[4].

Patent Expiration Date

This patent is set to expire on May 29, 2033. This expiration date is crucial as it determines when generic versions of Belsomra can be introduced to the market[4].

Claims and Scope of the Patent

Active Ingredient Protection

The patent protects the solid dosage formulations of the active ingredient, which is an orexin receptor antagonist. This means that only the patent holder, Merck Sharp & Dohme Corp., has the exclusive right to manufacture and market products using this specific formulation until the patent expires[1].

Specific Formulations

The patent focuses on the solid dosage forms of the drug, which include tablets, capsules, and other solid formulations. This protection extends to the specific methods of preparing these formulations, ensuring that any generic version must differ significantly in its formulation to avoid infringement[4].

Key Claims

Composition and Preparation

The patent claims cover the composition and preparation methods of the solid dosage formulations. This includes the specific ratios of the active ingredient to other components, the manufacturing process, and the final product characteristics[4].

Stability and Bioavailability

The claims also address the stability and bioavailability of the formulations. Ensuring that the drug remains stable and is absorbed effectively by the body is a critical aspect of the patent, as it directly impacts the drug's efficacy and safety[4].

Patent Landscape and Exclusivities

U.S. Patent Landscape

Belsomra is protected by multiple U.S. patents, including US 7,951,797 and US 11,980,623, in addition to US 10,098,892. These patents cover various aspects of the drug, including the active ingredient, dosage forms, and manufacturing processes. Understanding this broader patent landscape is essential for strategizing market entry and potential generic competition[1].

Exclusivities

Belsomra holds two exclusivities: New Chemical Entity (NCE) exclusivity, which expired on August 13, 2019, and another exclusivity that expired on January 29, 2023. These exclusivities, while now expired, previously provided additional market protection beyond the patent terms[1].

Legal Activities and Updates

Maintenance Fees and Patent Status

Recent legal activities include the payment of maintenance fees, which are critical for maintaining the patent's active status. For example, a maintenance fee for the 4th year was paid on March 9, 2022, for US 10,098,892[1].

FDA Notifications and Determinations

The patent has also been subject to various FDA notifications and determinations, such as the FDA Final Eligibility Letter and the Recordation of Patent Grant Mailed, which are important milestones in the patent's lifecycle[1].

Impact on Generic Launch

Estimated Generic Launch Date

Given the patent expiration dates, the estimated generic launch date for Belsomra is May 29, 2033. This date assumes that no significant legal challenges or term extensions occur that could alter the patent's expiration[1].

Market Strategy

Understanding the patent landscape and exclusivities is crucial for generic manufacturers planning to enter the market. Identifying markets with weaker patent protection can provide strategic advantages for early generic entry[1].

International Patent Protection

Global Patent Landscape

Belsomra is protected by patents in multiple countries, not just the United States. Analyzing the global patent landscape helps in identifying potential markets where generic versions could be launched earlier due to weaker or expired patent protection[1].

Conclusion

The United States Patent 10,098,892 plays a significant role in protecting the solid dosage formulations of Belsomra, an orexin receptor antagonist. Understanding the claims, scope, and legal activities surrounding this patent is essential for both the patent holder and potential generic competitors. The patent's expiration date of May 29, 2033, marks a critical milestone for the potential introduction of generic versions of Belsomra.

Key Takeaways

• Patent Title and Inventors: "Solid dosage formulations of an orexin receptor antagonist" by Harmon Paul A. and Variankaval Narayan.
• Patent Expiration Date: May 29, 2033.
• Claims and Scope: Protects the composition, preparation, stability, and bioavailability of solid dosage formulations.
• Legal Activities: Includes maintenance fees and FDA notifications.
• Impact on Generic Launch: Estimated generic launch date is May 29, 2033.
• International Protection: Protected by patents in multiple countries.

FAQs

Q: What is the primary use of Belsomra?

A: Belsomra is primarily used for the treatment of insomnia.

Q: Who owns the patent for Belsomra?

A: The patent for Belsomra is owned by Merck Sharp & Dohme Corp.

Q: What is the expiration date of US Patent 10,098,892?

A: The expiration date of US Patent 10,098,892 is May 29, 2033.

Q: Are there any generic versions of Belsomra available?

A: No, there are currently no therapeutically equivalent generic versions of Belsomra available in the United States[4].

Q: What are the exclusivities associated with Belsomra?

A: Belsomra had two exclusivities: New Chemical Entity (NCE) exclusivity and another exclusivity, both of which have expired[1].

Sources

1. Pharsight: Belsomra patent expiration.
2. Unified Patents Portal: EP-2854816-B1.
3. BioRxiv: A novel approach to understand patents from the drug discovery.
4. Drugs.com: Generic Belsomra Availability.

Drugs Protected by US Patent 10,098,892

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	10,098,892		Y

Foreign Priority and PCT Information for Patent: 10,098,892

PCT Information
PCT Filed	May 29, 2013	PCT Application Number:	PCT/US2013/042959
PCT Publication Date:	December 05, 2013	PCT Publication Number:	WO2013/181174

International Family Members for US Patent 10,098,892

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013267613
Australia	2018201279
Brazil	112014025041
Canada	2795550
China	104321059