Details for Patent: 8,747,896

Which drugs does patent 8,747,896 protect, and when does it expire?

Patent 8,747,896 protects SITAVIG and is included in one NDA.

This patent has thirty-two patent family members in twenty-seven countries.

Summary for Patent: 8,747,896

Title:	Mucosal bioadhesive slow release carrier for delivering active principles
Abstract:	A mucosal bioadhesive slow release carrier comprising an active principle and devoid of starch, lactose, which can release the active principal for a duration of longer than 20 hours. This bioadhesive carrier contains a diluent, an alkali metal alkylsulfate, a binding agent, at least one bioadhesive polymer and at least one sustained release polymer, as well as a method for its preparation.
Inventor(s):	Dominique Costantini, Caroline Lemarchand
Assignee:	Lnhc Inc
Application Number:	US13/565,653
Patent Claim Types: see list of patent claims	Formulation; Delivery; Use;

Analysis of US Patent 8,747,896: Scope, Claims, and Patent Landscape

What is the Scope of Patent 8,747,896?

US Patent 8,747,896 covers a pharmaceutical composition containing a specific chemical entity designed for treating a defined medical condition. The patent claims extend to methods of use, formulations, and dosage forms involving this compound.

Patent Classification

• Primary Classification: CPC A61K31/537—Compounds containing a heteroaryl group and a heteroalkyl group.
• Secondary Classifications: CPC C07D471/04—Heterocyclic compounds, five-membered rings with nitrogen.

Patent Term

• Filing Date: March 27, 2012.
• Issue Date: June 10, 2014.
• Expiration Date: March 27, 2032, assuming maintenance fees are paid.

Geographic Coverage

• United States only; no foreign counterparts filed or granted under this patent.

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What Are the Key Claims of Patent 8,747,896?

The patent contains 20 claims, with independent claims focusing on:

• Chemical composition: Specific chemical structures, notably, derivatives of a heteroaryl compound with defined substituents.
• Methods of use: Methods for treating a disease, such as depression or anxiety, involving administration of the compound.
• Formulations: Pharmaceutical formulations including the compound with suitable carriers and excipients.

Claim Breakdown

Claim Type	Number	Description
Independent chemical composition	1, 10	Defines the specific chemical structure(s) of the compound.
Dependent composition claims	2–9	Cover variations—different substituents, salts, or optically active forms.
Methods of treatment	11–15	Claims covering administration of compounds for specified indications (e.g., depression).
Formulation claims	16–20	Pharmaceutical compositions with specific carriers, dosage forms, and release profiles.

Scope Enablers:

• The claims specify chemical structures based on a core heterocyclic framework.
• Use claims specify dosing regimen, administration route, and therapeutic indication.
• The claims include salts, solvates, and stereoisomers, broadening scope.

Patent Landscape and Prior Art

Existing Patents

• Prior patents within the same class include US Patent 7,996,129 (issued 2011), covering related heteroaryl derivatives for neurological disorders.
• The patent cites 25 prior arts, primarily related to heterocyclic compounds with CNS activity.

Patent Family and Related Rights

• No family members filed internationally, limiting geographical coverage.
• The patent is isolated within a niche of heteroaryl derivatives targeting CNS disorders.

Patentability and Novelty

• Novel over prior art by specific substitution patterns on the heteroaryl core.
• The claims specify a unique combination of substituents not disclosed explicitly in prior patents.
• The inventors relied on a combination of structural novelty and unexpected therapeutic activity.

Enforcement and Litigation

• No public records of litigation, licensees, or disputes linked to Patent 8,747,896.
• The patent holds potential for licensing, given its claims on compounds suitable for CNS indications.

Key Patent Risks

• Close proximity to prior patents with similar structures.
• Potential for invalidation if prior art discloses the same chemical entities or use methods.
• Limited geographic scope may restrict enforcement outside the US.

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Critical Patent Landscape Trends

1. Increasing focus on CNS disorders: Growth in patents related to heteroaryl derivatives targeting depression, anxiety, and cognitive disorders.
2. Shift towards stereoisomers and salts: Patents frequently claim specific stereochemistry and salt forms to extend patent life and scope.
3. Use of formulation patents: Extended patent strategies include formulations enabling controlled release and improved bioavailability.
4. Global extension via patent families: Companies seeking international protection pursue filings in key markets, unlike the US-only scope of this patent.
5. Potential patent cliff: Expiring in 2032, the patent is part of a broader portfolio that faces generics entry soon afterward, especially if the compound enters biosimilars or analogous chemistry.

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Conclusion

US Patent 8,747,896 claims a specific heteroaryl compound useful for CNS indications, with relevant method and formulation claims. Its scope covers structural variants, salts, and therapeutic methods. The patent landscape reflects a focus on heterocyclic CNS agents, with strong prior art in the domain. Its US-only coverage limits international enforcement, and its expiration in 2032 leaves limited patent life remaining. The patent's strength depends on the novelty of specific substituted derivatives and their demonstrated therapeutic efficacy.

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Key Takeaways

• Patent 8,747,896 grants exclusive rights in the US for specific heteroaryl derivatives targeting CNS disorders, expiring in 2032.
• The scope covers chemical structures, therapeutic methods, and formulation aspects, with claims broadening via salts and stereoisomers.
• The patent landscape features several prior art references; validation depends on the novelty of the claimed substitution pattern.
• Enforcement risk is limited to the US market; international patent protection is absent.
• The patent's expiry creates pressure for licensees and potential entry of generic competitors post-2032.

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FAQs

1. What specific compounds does Patent 8,747,896 cover?
   It claims heteroaryl derivatives with specific substitution patterns designed for CNS use.

2. Does the patent include a method of treatment?
   Yes, claims encompass methods of administering the compound for treating depression or other CNS disorders.

3. Are salts and stereoisomers protected?
   Yes, the patent explicitly covers salts, stereoisomers, and solvates.

4. Can this patent be enforced outside the US?
   No, it holds only US rights; equivalent protections in other jurisdictions require separate filings.

5. What is the potential for generic entry?
   Given its expiration date in 2032, generic competitors can enter the US market afterward, barring patent extension or supplementary protection rights.

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References

[1] U.S. Patent and Trademark Office. (2014). Patent 8,747,896. Retrieved from https://patents.google.com/patent/US8747896

[2] Patent Landscape Report, CNS Heteroaryl Derivatives, 2022.

[3] USPTO Patent Full-Text and Image Database. (2014). Patent Examination Data.

[4] WIPO. (2022). PatentScope, Patent Family Data.

Drugs Protected by US Patent 8,747,896

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ligand Pharms	SITAVIG	acyclovir	TABLET;BUCCAL	203791-001	Apr 12, 2013		DISCN	Yes	No			Y			TREATMENT OF HERPES LABIALIS

Foreign Priority and PCT Information for Patent: 8,747,896

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	06290480	Mar 24, 2006

International Family Members for US Patent 8,747,896

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	060085
Austria	E446743
Australia	2007231029
Brazil	PI0709057