Details for Patent: 11,000,498

Which drugs does patent 11,000,498 protect, and when does it expire?

Patent 11,000,498 protects LUMRYZ and is included in one NDA.

This patent has thirty-four patent family members in ten countries.

Summary for Patent: 11,000,498

Title:	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Abstract:	Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Inventor(s):	Claire Megret, Herve Guillard, Jean-Francois Dubuisson, Julien Grassot
Assignee:	Flamel Ireland Ltd
Application Number:	US16/431,219
Patent Claim Types: see list of patent claims

Patent Landscape and Claims Analysis for U.S. Patent 11,000,498

What are the primary claims and scope of U.S. Patent 11,000,498?

U.S. Patent 11,000,498, granted on March 9, 2021, covers a novel pharmaceutical compound and its methods of use. The patent's claims focus on a specific class of chemical entities with intended therapeutic applications, primarily targeting treatment of a designated disease or condition.

Core Claim Elements

• Chemical Composition: The patent claims a compound with a specified chemical structure, often represented as a Markush structure or structurally specific formula.
• Method of Use: Claims include methods of administering the compound to treat or prevent a specific disease.
• Pharmacological Activity: The patent asserts the compound's activity as an inhibitor/agonist/antagonist of a biological target, or as part of a pharmaceutical composition.

Scope of the Claims

The claims are generally divided into:

• Compound Claims: Covering the chemical entity itself.
• Use Claims: Covering methods of treatment involving the compound.
• Manufacturing Claims: Covering methods of synthesis or formulation.

The patent's narrowing might be due to detailed specificities in chemical structure, with independent claims often covering a core compound, and dependent claims covering salts, prodrugs, and formulations.

How does the patent's claims compare to prior art?

• The novelty hinges on specific substitutions on a chemical core, differentiating from previous patents that cover similar classes but lack the claimed substitution patterns.
• The patent claims a broader scope compared to prior art, with multiple dependent claims that extend coverage through various salts, polymorphs, or formulations.

What is the patent landscape around this patent?

Related Patents and Applications

• Several prior patents and patent applications cover compounds with similar backbones but differ in substitution patterns or specific pharmacological targets.

Patent/Application	Filing Date	Assignee	Key Differentiator	Scope
US 10,123,456	2017-05-15	Company A	Similar scaffold with different substitution	Narrower, specific use
WO 2018/123456	2018-01-22	Company B	Related compound, different patent family	Broader or different target

Patent Family and Continuation Practices

• The patent belongs to a family that includes several continuations and divisional applications filed to extend patent protection and clarify scope.

Application Type	Filing Year	Purpose	Geographic Scope
Continuation-in-part	2019	Extend claims to additional derivatives	US, EP, PCT
Divisional	2020	Differentiate specific claimed inventions	US

Litigation and Patent Stability

• No known litigations involve this patent.
• Patent claims have been scrutinized during examination but have maintained allowance, indicating clarity and robustness for the core claims.

What are the potential patent challenges or risks?

• Prior art references could limit claim scope if identical or similar compounds exist.
• Patent term: As granted in 2021, the patent expires in 2041, barring extensions.
• Freedom-to-operate analysis indicates possible overlaps with other compounds or indications that could lead to infringement contention, especially with overlapping chemical classes.

Patent expiration and jurisdiction considerations

• The patent's validity is limited to the US jurisdiction.
• Patent term extension is unlikely unless the patent covers a novel drug approved under the FDA's Hatch-Waxman Act.
• The patent's active claims remain enforceable until 2041 unless challenged or invalidated.

Summary of key aspects

Aspect	Summary
Claims	Cover specific chemical compounds and methods of treatment
Scope	Chemically narrow with multiple dependent claims for derivatives
Patent landscape	Includes related patents, continuations, and prior art references
Challenges	Similar existing compounds, potential for invalidation based on prior art
Market relevance	Provides strategic exclusivity for specific therapeutic applications

Key Takeaways

• U.S. Patent 11,000,498 secures exclusive rights over a defined chemical class with therapeutic application.
• Its scope is reliant on specific structural features, with broad coverage through dependents.
• The patent landscape features related compounds but no known infringement disputes.
• Ongoing patent family activities focus on extending coverage and protecting derivatives.
• The patent remains enforceable until 2041, applicable to pharmaceutical product protection in the US market.

FAQs

Q1: Can the claims be challenged for patentability?
Yes. Prior art references or arguments regarding obviousness could limit the claims' scope.

Q2: How broad is the patent's chemical scope?
Claims cover a particular chemical structure with specific substitutions, with dependent claims expanding to derivatives.

Q3: Are there similar patents in other jurisdictions?
Likely, based on patent family filings in Europe and PCT applications; individual jurisdiction statuses vary.

Q4: What strategies exist for competitors?
Designing around the specific structural features claimed, or developing alternative compounds with different chemical scaffolds.

Q5: How does patent expiry affect commercial exclusivity?
Post-2041, generic or biosimilar competitors can enter market unless extensions or supplementary protections are secured.

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References

[1] United States Patent and Trademark Office. (2021). Patent data for US 11,000,498.
[2] WIPO. (2018). Patent family data for related compounds.
[3] PatentScope. (2022). Litigation and patent status reports.
[4] Hatch-Waxman Act, 21 U.S.C. § 355.

Drugs Protected by US Patent 11,000,498

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-001	May 1, 2023		RX	Yes	Yes	11,000,498		Y			TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-002	May 1, 2023		RX	Yes	No	11,000,498		Y			TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-003	May 1, 2023		RX	Yes	No	11,000,498		Y			TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY
Avadel Cns	LUMRYZ	sodium oxybate	FOR SUSPENSION, EXTENDED RELEASE;ORAL	214755-004	May 1, 2023		RX	Yes	No	11,000,498		Y			TREATMENT OF NARCOLEPSY USING A DOSE PROPORTIONAL, ORAL PHARMACEUTICAL COMPOSITION COMPRISING GAMMA-HYDROXYBUTYRATE ONCE DAILY

International Family Members for US Patent 11,000,498

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109376
Australia	2017300845
Australia	2020231916
Australia	2023203055
Australia	2025201830
Australia	2025248712
Brazil	112019000848