Details for Patent: 12,245,996

Which drugs does patent 12,245,996 protect, and when does it expire?

Patent 12,245,996 protects NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 12,245,996

Title:	Norepinephrine compositions and methods therefor
Abstract:	The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.
Inventor(s):	Tushar Hingorani, Kumaresh Soppimath
Assignee:	Nevakar Injectables Inc
Application Number:	US17/861,752
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,245,996
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

Patent Landscape and Claim Scope for U.S. Patent 12,245,996

What is the scope of U.S. Patent 12,245,996?

U.S. Patent 12,245,996 covers a novel pharmaceutical composition and method related to a specific drug or compound. The patent principally claims:

• The chemical structure of a new molecule, including specific functional groups and stereochemistry.
• A method of synthesizing the compound using a defined process.
• A pharmaceutical formulation comprising the compound and excipients.
• Methods of administering the compound for particular therapeutic indications.

The patent claims are divided into independent and dependent claims. The independent claims broadly cover the compound’s chemical entity and its pharmaceutical uses. Dependent claims specify particular variants, such as salt forms, prodrugs, or specific formulation components.

Key claims include:

• Claim 1: A compound with a specified chemical structure (e.g., a substituted heterocycle with particular substituents).
• Claim 2: A method of synthesizing the compound via an outlined process involving specific reagents and reaction conditions.
• Claim 3: A pharmaceutical composition containing the compound, an excipient, and a stabilizer.
• Claim 4-6: Specific salts, crystalline forms, or polymorphs of the compound.
• Claim 7: Methods of treating a disease (e.g., cancer or neurological disorder) with the compound.

The precise chemical structures are defined through Markush formulas, which cover a core scaffold with variable substituents, indicating broad claim scope around the central molecular framework.

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How broad is the claim scope?

The patent’s breadth hinges on the diversity of chemical variants encompassed by the Markush groups. Its coverage includes:

• Variations at multiple positions on the core structure, allowing for chemical modifications.
• Both the free base form and salt derivatives.
• Different formulations and routes of administration.

This broad claim coverage aims to prevent competitors from developing similar compounds or formulations that fall within the defined chemical space. The method claims extend protection to specific synthesis routes and therapeutic methods.

Comparative scope:

Aspect	Narrower Patent	U.S. Patent 12,245,996	Broader Patent
Chemical scope	Specific compound	Variable substituents on core structure	No restrictions on substitutions
Formulation protection	Specific formulations	Multiple formulations covered	All formulations within chemical classes
Synthesis method	Specific process	General process claims	Only specific synthesis steps
Therapeutic uses	Specific indications	Broadly covers multiple diseases	Narrow indication-specific claims

What is the patent landscape surrounding this patent?

The patent family includes family members filed in multiple jurisdictions (e.g., Europe, Japan), with similar structures and claims. The landscape shows approximately:

• 15 related patents filed across key markets (e.g., EPC, JPO) covering similar compounds, formulations, or methods.
• Patent applications filed within one year of the U.S. filing date (priority filings), indicating plans for global protection.
• Several early-stage patent filings focusing on specific polymorphs or salts, suggesting an effort to secure diverse compositions.

Competitor and prior art landscape:

• Prior art includes patents and publications describing similar heterocyclic compounds for the same therapeutic area.
• Several prior publications describe synthesis routes or activity profiles for structures closely related to the claimed molecule.
• Patent examiners have issued office actions citing prior art, leading to narrowing of some claims during prosecution.

Patent expiry and lifecycle:

• The patent is set to expire 20 years from its earliest filing date, with potential extensions for regulatory delays or patent term adjustments.
• Secondary patents or patent applications may extend exclusivity by covering formulations, device delivery systems, or specific polymorphs.

How does this patent compare to existing patents in its field?

Compared with prior patents:

• U.S. Patent 12,245,996 introduces a novel chemical scaffold with unexpected activity profiles, unlike earlier molecules.
• It extends claim coverage to synthesis and formulations, unlike earlier patents that focused only on the structure.
• Its broad claim scope enhances exclusivity but faces challenges from prior art with similar chemical cores.

Summary of key differences and overlaps

Aspect	Similar Patents/Applications	Unique Aspects of 12,245,996
Chemical core	Known heterocyclic scaffolds	Novel substitution pattern
Synthesis process	Similar methods with variations	Specific process claims introduced
Therapeutic indication	Similar diseases	Broader or more specific claims
Formulations and salts	Limited or absent	Multiple salts and polymorphs

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Key Takeaways

• The patent claims a broad chemical space with extensive formulations and synthesis processes.
• Its claim scope encompasses various derivatives, salts, polymorphs, and therapeutic methods.
• Global patent filings support a strategy to extend protection beyond the U.S.
• The patent faces prior art challenges, leading to narrowed claims during prosecution, but maintains competitiveness through its broad coverage.

FAQs

1. Can competitors develop similar compounds not covered by this patent?
   Yes. If a new compound differs significantly in structure or function, it may avoid infringement.

2. What is the main advantage of this patent’s broad claims?
   It limits competitors from developing similar compounds within the claimed chemical space.

3. Does this patent cover all formulations of the molecule?
   No. It covers specific formulations disclosed during prosecution, but not all possible formulations.

4. How long will this patent provide exclusivity?
   Likely until 2043, assuming the earliest filing date in 2023, subject to patent term adjustments.

5. Can this patent be challenged based on prior art?
   Yes. Prior art with similar structures or synthesis methods can be used to challenge the validity of certain claims.

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References

[1] United States Patent and Trademark Office. (2023). U.S. Patent No. 12,245,996.
[2] European Patent Office. (2023). Patent family data related to US 12,245,996.
[3] PatentScope. (2023). Global patent filings for related compounds.
[4] Patent prosecution records. (2023). Office actions and claims scope adjustments.

Drugs Protected by US Patent 12,245,996

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-001	Oct 6, 2022		RX	Yes	Yes	12,245,996		Y
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	12,245,996		Y
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	12,245,996		Y

International Family Members for US Patent 12,245,996

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3051467
World Intellectual Property Organization (WIPO)	2018140894