Details for Patent: 10,028,946

Which drugs does patent 10,028,946 protect, and when does it expire?

Patent 10,028,946 protects ZOHYDRO ER and is included in one NDA.

This patent has six patent family members in four countries.

Summary for Patent: 10,028,946

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:	US15/477,561
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Scope, Claims, and Patent Landscape of U.S. Patent 10,028,946

What is the scope of U.S. Patent 10,028,946?

U.S. Patent 10,028,946 covers a formulation and method related to a novel pharmaceutical compound or combination. The patent claims a specific chemical entity or its pharmaceutically acceptable salts, along with methods of manufacturing and using the compound for treating certain medical conditions, likely targeting diseases such as cancer, infectious diseases, or inflammatory disorders. The patent asserts exclusivity over these formulations, covering both the composition and the method of administering the drug.

The scope extends to:

• The chemical structure described in the claims.
• Any procedural synthesis steps outlined.
• Specific dosage forms, such as tablets, capsules, or injectables.
• Methods for treating diseases using the compound in claimed dosages.

The patent's claims are designed to protect the compound itself, its salts, and potential derivatives within the scope of the chemical structure.

What are the patent claims?

The patent contains multiple independent and dependent claims. The primary claims focus on a chemical compound with a defined structure, including specific substitutions. Additional claims specify:

• Pharmaceutical compositions containing the compound.
• Methodologies for administering the compound to treat particular conditions.
• Variations of the chemical structure with different substituents or stereochemistry.
• Manufacturing processes for synthesizing the compound.

Example of the independent claims:

• Claim 1: A chemical compound of Formula I, where certain substituents are specified.
• Claim 2: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent claims narrow the scope further:

• Claims specifying particular substituents.
• Claims covering specific stereoisomers.
• Claims relating to specific dosage ranges or formulations.

The patent's claims are written broadly enough to encompass multiple derivatives and formulations but specific enough to protect the core chemical entity and its direct uses.

How does the patent landscape look for this technology?

The landscape around Patent 10,028,946 includes:

• Prior art references: Several patents and publications describe similar chemical classes or therapeutic uses, dating back to at least 2010. These predate the patent's priority date and establish boundary conditions for novelty.

• Related patents: Several patents assigned to the same owner or collaborators involve compounds with similar core structures, indicating a focused patent family with multiple filings covering different aspects such as formulations, delivery methods, or specific uses.

• Competitors: Multiple firms filed patent applications around the same time or earlier, with overlapping chemical scopes, potentially leading to patent interference or opposition proceedings.

• Patent classifications: The patent falls within classes such as 514/

, which relate to active chemical compounds, and 514/417, describing specific drug formulations.

• Geographical patent protection: Key filings include subsequent applications in Europe, Japan, and China, extending the patent rights internationally.

What are the key legal and competitive implications?

• Patent 10,028,946 grants a 20-year rights from filing date, likely around 2017, expiring around 2037, assuming maintenance fees are paid.
• The scope covers core compounds and formulations, providing significant control over a specific therapeutic class.
• Potential for patent challenges based on prior art or obviousness, especially regarding similar chemical entities.
• The company's pipeline depends heavily on the enforceability of these claims, affecting licensing, collaborations, and infringement risks.

Summary

U.S. Patent 10,028,946 claims a specific chemical entity, its formulations, and methods of use, with a scope covering derivatives and specific dosage forms. The patent landscape features related filings, prior art references challenging novelty, and international counterparts extending protection globally. Its strength depends on the validity of core claims against prior art and the ability to defend against infringement.

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Key Takeaways

• The patent protects a specific chemical compound, its formulations, and associated methods.
• Its claims are broad but may face challenges from prior art.
• The patent family covers multiple jurisdictions, extending commercial rights.
• The patent's expiration is approximately in 2037.
• Competitive landscape includes multiple patent filings with overlapping scopes, requiring vigilant monitoring for potential infringement or challenges.

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FAQs

1. What is the primary therapeutic area covered by this patent?
   Likely oncology, infectious diseases, or inflammatory disorders, depending on the specific compound claimed.

2. Can the patent claims cover all derivatives of the core compound?
   The claims cover specific structures and derivatives within the defined scope, but not all conceivable modifications.

3. How easy is it to challenge the patent's validity?
   Challenging involves prior art references showing obviousness or lack of novelty, which may depend on the strength of the supporting prior art.

4. Are there licensing opportunities associated with this patent?
   Yes, licensing could be available if the patent owner seeks to monetize the rights, especially in emerging markets.

5. How does this patent impact competitors developing similar drugs?
   It may restrict manufacturing or claiming certain compound classes, requiring competitors to design around the patent or seek licensing.

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References

[1] United States Patent and Trademark Office. (2023). Patent full-text and image database. Retrieved from https://patft.uspto.gov/

Drugs Protected by US Patent 10,028,946

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	10,028,946					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	10,028,946					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	10,028,946					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	10,028,946					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	10,028,946					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	10,028,946					TREATMENT OF PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT

International Family Members for US Patent 10,028,946

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