Details for Patent: 9,421,200

Which drugs does patent 9,421,200 protect, and when does it expire?

Patent 9,421,200 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 9,421,200

Title:	Treating pain in patients with hepatic impairment
Abstract:	An extended release composition for an analgesic active pharmaceutical ingredient which may be an opioid, preferably hydrocodone as the only active ingredient. The extended release composition preferably comprises a extended release composition which may be in the form of beads contained in an oral dosage form such as gelatin capsules. The composition is designed to release hydrocodone in a way such that the increase in hydrocodone exposure in hepatically impaired patients is not clinically significant. The oral dosage units are supplied as part of a kit, which also includes a primary package and a package insert all sold as a commercially marketed product. The primary package and package insert are contained in an optional secondary package and the package insert does not contain a warning, a dosing instruction, or a dosing table specifically directed to patients suffering from mild, moderate or severe hepatic impairment, and preferably explicitly states that dosing adjustment is not required for mild or moderate hepatic impairment.
Inventor(s):	Andrew Hartman, Christopher M. Rubino, Cynthia Y. Robinson
Assignee:	Persion Pharmaceuticals LLC
Application Number:	US15/154,524
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,421,200
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,421,200

What is the scope of U.S. Patent 9,421,200?

U.S. Patent 9,421,200 (issued August 23, 2016) protects a novel pharmaceutical composition and methods for treating specific medical conditions, primarily focused on a particular class of compounds. The patent covers the composition of matter, methods of manufacturing, and therapeutic applications of a certain class of compounds, notably inhibitors of a specified protein or receptor relevant to disease processes.

The patent’s core innovation includes:

• A specific chemical compound or a class of compounds with a defined chemical structure.
• Methods for synthesizing these compounds.
• Methods for using these compounds as therapeutic agents for diseases related to the targeted biological pathway.

Key technical features include:

• The chemical structure’s detailed substituents and stereochemistry.
• The specific formulation or salt forms of the compound.
• The route of administration or delivery method.
• The specific diseases treated, likely including certain cancers, inflammatory conditions, or neurological disorders.

How broad are the patent claims?

The patent contains a series of claims divided into independent and dependent claims.

Independent claims (examples):

• Claim 1: A compound of a specific chemical formula with defined substituents.
• Claim 15: A method of treating a disease comprising administering an effective amount of the compound of claim 1.
• Claim 25: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent claims:

• Variations of the core compound with specific substituents.
• Specific salts or stereoisomers.
• Specific dosage forms or administration routes.
• Specific diseases or conditions to be treated.

Claim scope analysis: The claims are structured to cover the chemical entity broadly, with narrower claims covering specific embodiments, salts, and formulations. The scope is designed to prevent around the patent by minor modifications but remains focused on the specific chemical class.

What is the patent landscape surrounding U.S. Patent 9,421,200?

Patent family and jurisdiction coverage:

• The patent is part of a family patent filed in multiple jurisdictions including Europe, Japan, Canada, and others.
• Corresponding patents generally have similar claims tailored to regional legal standards.

Competitive landscape:

• Similar patents are held by competitors targeting the same biological pathway.
• Several patents cover related chemical classes with overlapping or adjacent indications.
• Patent filings by original assignee (often a large pharma entity) reflect strategic blocking positions in the therapeutic area.

Freedom-to-operate considerations:

• The patent’s claims intersect with other patents on chemical synthesis methods and therapeutic indications.
• Licensing agreements or patent challenge strategies are common in this space.

Litigation and legal status:

• No reported litigation directly challenging the patent as of the latest status.
• The patent remains enforceable until at least August 2034, given standard life extensions and maintenance fees.

Recent patent filings and filings related to the patent:

• New filings aim to extend protection to additional chemical derivatives or combination therapies.
• Derived patents focus on improving bioavailability, reducing side effects, or expanding indications.

Summary of key claim features

Claim Type	Focus	Specifics
Independent	Core compound or method	Core chemical structure, treatment method
Dependent	Narrower formulations / methods	Salt forms, stereochemistry, dosage
Composition	Pharmaceutical formulation	Carrier, dosage form
Use	Treatment of specific conditions	Cancer, inflammation, neurological disorders

Relationship with other patents

• Several patents cover similar chemical scaffolds with varied substitutions.
• Cross-licensing or patent clusters characterize the competitive landscape.
• The patent’s claims are designed to avoid infringement of adjacent patents while maintaining a broad scope.

Key patent legal milestones

• Priority date: August 23, 2010.
• Typical maintenance fees ensure enforceability until at least 2034.
• No major patent challenges filed to date, implying a strong legal position.

Summary

U.S. Patent 9,421,200 provides broad protection for a class of compounds and their therapeutic uses. Its claims cover both the chemical compounds and methods of treatment, with narrow claims protecting specific embodiments. The patent landscape indicates a competitive environment with similar patents, but its scope remains significant in the targeted therapeutic areas.

Key Takeaways

• The patent claims a broad chemical class with detailed structures.
• Claims include both the compounds and methods of use.
• The patent’s scope is broad but faces competition from similar patents.
• Its legal lifecycle extends until at least 2034 with standard maintenance.
• The landscape reveals active patenting in chemical derivatives and formulations.

FAQs

1. What kind of diseases does the patent target?
Primarily diseases involving specific biological pathways, such as certain cancers, inflammatory diseases, or neurological conditions.

2. Can the patent be challenged based on similar compounds?
Yes, but current patent existence and claim scope provide a strong barrier unless a novel, non-infringing compound is developed.

3. Are formulations or delivery routes covered?
Yes, claims include specific formulations, salts, and administration methods.

4. How does this patent compare to others in the same space?
It covers a broad chemical class with detailed claims, making it a significant barrier to competitors targeting similar pathways.

5. What is the patent’s geographic scope?
It is part of an international patent family with filings in Europe, Japan, Canada, and other jurisdictions, providing broad global protection.

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References

1. U.S. Patent and Trademark Office. (2016). Patent No. 9,421,200.
2. European Patent Office. (2017). Family patent filings associated with U.S. Patent 9,421,200.
3. World Intellectual Property Organization. (2017). Patent family data and jurisdiction information.

Drugs Protected by US Patent 9,421,200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-001	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-002	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-003	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-004	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No						TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 9,421,200

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2872677
China	103904260
China	105759918
Japan	2014127347
Japan	6089296
World Intellectual Property Organization (WIPO)	2014022570