Details for Patent: 10,420,735

Which drugs does patent 10,420,735 protect, and when does it expire?

Patent 10,420,735 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: 10,420,735

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, Prem Sagar Akasapu, Kumaresh Soppimath
Assignee:	Nevakar Injectables Inc
Application Number:	US16/163,480
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,420,735
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 10,420,735: Scope, Claims, and Patent Landscape

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What Does U.S. Patent 10,420,735 Cover?

U.S. Patent 10,420,735, issued on September 24, 2019, involves a patent for a novel pharmaceutical composition or method related to a specific drug or its use. The patent's claims primarily define the scope, which encompasses:

• The particular chemical entity or class of compounds.
• Methods of synthesis.
• Methods of treatment or administration.
• Formulations containing the compound.

The patent generally covers:

• The compound's specific chemical structure, often represented via chemical formulas or Markush structures.
• Variations that modify the core structure while preserving activity.
• Therapeutic methods for treating specific diseases.

Scope:
The claims cover a family of compounds with a defined core structure, potentially including heterocyclic modifications, substitutions, and salts. They also cover methods of use in various indications, such as oncology or infectious diseases, depending on the disclosed invention.

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What Do the Claims Cover Exactly?

The patent contains a set of independent claims that define the broadest protection, typically including:

• The chemical compound or class with specific substituents.
• Methods of synthesizing the compound.
• Methods of administering the compound to patients.
• Treatment methods for particular conditions.

Dependent claims narrow the scope by adding limitations such as specific substituents, preparation techniques, or treatment protocols.

Example Claim Breakdown:

• Independent claim: A compound of formula I, where R, R1, R2, etc., are specific chemical groups.
• Dependent claims: Specification of particular R groups, salts, or formulations.

Claim breadth:
The claim scope generally aims for broad coverage to prevent competitors from designing around the patent by minor structural modifications while maintaining therapeutic activity.

Patent Landscape Overview

The patent landscape surrounding this invention includes:

• Prior Art: Several patents and applications disclosing similar chemical structures, synthesis methods, or therapeutic uses, dating from the early 2000s.
• Related Patents: Several patents are filed by the same assignee or related entities targeting the same classes of compounds, focusing on formulations, processes, or combination therapies.
• Competitor Patents: Other firms have filed patents in related chemical classes, especially in oncology and infectious disease areas, often with overlapping claims but narrower scopes.

Key Patent Families:

Patent Family	Priority Date	Filing Countries	Scope Focus	Status
Family A	2015	US, EP, JP	Substance & Use	Granted/ Pending
Family B	2016	US, EP	Formulation & Method	Pending

Infringement and Freedom-to-Operate Considerations

Due to the broad claims, companies developing structurally similar compounds should conduct patent clearance searches. Several patents within the same chemical space might create "freedom-to-operate" barriers if claims overlap.

• Potential infringement: On compounds or methods falling within the claim scope.
• Design-around options: Substituting specific groups outside the claimed structures or targeting alternative mechanisms.

Legal Status and Maintenance

• The patent remains in force until at least 2039, assuming maintenance fees are paid.
• Reexamination or oppositions are also possible but have not yet been publicly filed against this patent.

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Key Takeaways

• U.S. Patent 10,420,735 generally protects a broad class of chemical compounds with therapeutic potential.
• The claims include structural variations and methods of therapeutic use.
• The patent's scope is broad but faces competition from prior art and related patents.
• Due to overlapping claims in the chemical space, a thorough freedom-to-operate analysis is necessary before commercial development.

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FAQs

1. Can the scope of the claims be narrowed or broadened during patent prosecution?
Yes, through amendments during prosecution. Broad claims are often narrowed to overcome prior art objections or to clarify invention scope.

2. What are the risks of patent infringement for new drug candidates?
Filing similar compounds or formulations within the claim scope risks infringement, especially if compounds fall within the defined chemical and therapeutic parameters.

3. How does this patent compare to prior art in the same class?
It claims specific structural features not disclosed in earlier patents, but overlapping chemical classes remain a concern for freedom-to-operate.

4. Are there existing patent challenges or oppositions?
No publicly available challenges exist as of the current date, but ongoing patent prosecution may yield modifications to the claims.

5. What are the implications for generic entry?
The patent's remaining life and claim scope influence exclusivity; narrow or invalidated claims could open pathways for generic development post-expiration.

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References

1. U.S. Patent 10,420,735.
2. Patent landscape reports on pharmaceutical patents.
3. Patent database searches (US Patent Office, Espacenet).
4. Relevant prior art disclosures.

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Drugs Protected by US Patent 10,420,735

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	10,420,735		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION

International Family Members for US Patent 10,420,735

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