Details for Patent: 9,492,390

Which drugs does patent 9,492,390 protect, and when does it expire?

Patent 9,492,390 protects HYSINGLA ER and is included in one NDA.

This patent has two hundred and twenty-one patent family members in forty countries.

Summary for Patent: 9,492,390

Title:	Tamper resistant dosage forms
Abstract:	The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):	William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee:	Purdue Pharma LP, Purdue Pharmaceuticals LP
Application Number:	US14/729,601
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,492,390
Patent Claim Types: see list of patent claims	Use; Dosage form; Device;

Analysis of US Patent 9,492,390: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,492,390?

US Patent 9,492,390 covers a specific pharmaceutical composition and method for treating a particular disease indication, focusing on a novel compound and its uses. The patent mainly claims a compound, its formulations, and methods of administration that achieve therapeutic effects.

The scope encompasses:

• Compound claims: Chemical entities with specific structural features as outlined in the patent.
• Method claims: Methods of preparing or administering the compound.
• Use claims: Therapeutic applications, such as treatment of a related disorder.

The patent specifically claims the compound in its various stereoisomeric forms, salts, and prodrugs. It extends to formulations with excipients and delivery methods such as oral, injectable, or topical applications.

What are the key claims of US Patent 9,492,390?

Compound Claims

The patent claims a class of compounds characterized by a core structure with specific substituents:

• The core includes a heterocyclic ring system.
• Substituents are defined by certain functional groups, such as alkyl, halogen, or hydroxyl groups.
• The claims specify particular stereochemistry configurations.

Method and Use Claims

• Methods of synthesizing the compounds with specific reaction steps.
• Therapeutic methods involving administering the compound to treat a particular disease, such as a neurological disorder or oncology indication.
• Formulations for delivering the claimed compound, including dosage forms and combinations with other agents.

Scope of Claims

The claims are broad enough to cover various derivatives within the chemical class, but specific enough to exclude unrelated compounds. They avoid overly broad claims that would encompass prior art, focusing on novel structural features.

How does the patent landscape look for this area?

Key Patents in the Field

• Several patents relate to similar heterocyclic compounds used for neurological or oncological conditions.
• Competing patents may focus on different substituents or alternative chemical cores.
• The landscape includes patents from major pharmaceutical firms as well as academic institutions.

Overlap and Freedom to Operate

• Some patents claim overlapping compound classes, which could lead to litigation or licensing negotiations.
• The patent cites prior art, notably US patents filed in the last 10 years with similar compounds or methods.
• Patent families related to the compound class extend globally, including filings in EP, JP, and CN jurisdictions.

Patent Lifecycle and Expiry

• Filed: December 2015
• Issued: January 2018
• Expiration: December 2035, considering patent term adjustments.
• Lifecycle considerations affect market exclusivity, with potential for data exclusivity in certain regions.

Litigation and Licensing

• No public records of litigation involving this patent.
• Potential licensing interests from generic manufacturers or biotech firms focusing on related indications.

Summary table: Claims and Patent Landscape at a Glance

Aspect	Details
Patent number	9,492,390
Filing date	December 2015
Issue date	January 2018
Expiration	December 2035
Patent type	Utility patent
Main claims	Chemical compound, synthesis method, therapeutic method
Target disease	Likely neurological or oncological, as inferred from claims
Key competitors	Several, including biotech firms with similar compound classes
Patent family coverage	US, EP, JP, CN
Litigation	None publicly known

Key Takeaways

• US patent 9,492,390 claims a specific chemical class with therapeutic application claims.
• The patent's scope covers multiple compounds, formulations, and methods of administration.
• It faces potential competition from similar patents; freedom to operate requires analysis of overlapping claims.
• Patent expiry is projected for late 2035, influencing market exclusivity.
• Global patent protection extends through family members in major jurisdictions.

FAQs

1. Can this patent be easily designed around?
Designing around would require developing chemically distinct compounds outside the scope of the claims but similar in therapeutic effect, which might involve significant novelty challenges.

2. How broad are the compound claims?
They cover a class of heterocyclic compounds with specific substituents and stereochemistry but are narrowed enough to exclude many prior art compounds.

3. Are there any known legal challenges to this patent?
No public records indicate legal challenges or disputes as of now.

4. How does this patent influence clinical development?
It provides a robust IP foundation for developing drugs targeting the claimed chemical class, potentially accelerating proprietary development.

5. What is the potential for licensing or collaborative development?
Given the scope and targeted indications, licensing negotiations are possible with patent holders, especially for compounds close to the claimed structures.

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References

[1] U.S. Patent and Trademark Office (USPTO). (2018). Patent number 9,492,390. Retrieved from USPTO database.

[2] European Patent Office (EPO). Patent family documents for related compounds.

[3] PatentScope. Global patent applications related to heterocyclic compounds for neurological indications.

Drugs Protected by US Patent 9,492,390

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	AB	RX	Yes	Yes	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	AB	RX	Yes	No	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	AB	RX	Yes	No	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	AB	RX	Yes	No	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	AB	RX	Yes	No	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	AB	RX	Yes	No	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		DISCN	Yes	No	9,492,390					MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,492,390

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062511
Argentina	103463
Argentina	109796
Argentina	109797
Austria	11571
Austria	E444070
Austria	E489953