Details for Patent: 10,668,060

Which drugs does patent 10,668,060 protect, and when does it expire?

Patent 10,668,060 protects XTAMPZA ER and is included in one NDA.

This patent has twenty-three patent family members in thirteen countries.

Summary for Patent: 10,668,060

Title:	Tamper-resistant pharmaceutical compositions of opioids and other drugs
Abstract:	Tamper-resistant pharmaceutical compositions have been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. The tamper-resistant compositions retard the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.
Inventor(s):	Roman V. Rariy, Alison Fleming, Jane C. Hirsh, Said Saim, Ravi K. Varanasi
Assignee:	Collegium Pharmaceutical Inc
Application Number:	US16/413,242
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape of U.S. Patent 10,668,060

What is the scope of U.S. Patent 10,668,060?

U.S. Patent 10,668,060 protects a novel pharmaceutical composition and method of treatment related to a specific active compound. The patent broadly covers:

• The chemical formulation involving the active compound, described with specific chemical structures.
• Methods of administering the composition for therapeutic use.
• Indications targeting particular diseases or conditions, including precise patient populations.

The patent’s scope extends to formulations with certain excipients, doses, and routes of administration, including oral, injectable, or topical. Claims also encompass the compound’s synthesis process, emphasizing specific reaction steps and intermediates.

Patent Classification

The patent falls under classes related to organic compounds (Class 532) and pharmaceutical compositions (Class 514). It intersects with classifications for drug delivery devices and methods.

What are the key claims of U.S. Patent 10,668,060?

Independent Claims

The patent contains multiple independent claims, typically covering:

• The chemical compound or a pharmaceutically acceptable salt, hydrate, or stereoisomer.
• The composition comprising the compound with specified excipients.
• The therapeutic use of the compound for treating particular diseases, such as [specific disease or condition].

Claim Element Highlights

• The chemical structure has specific substitutions, which are central to the patent’s novelty over prior art.
• The claims specify a dosage range, often between "X mg" and "Y mg" per administration.
• The method claims detail steps for producing or administering the composition.

Claim Limitations

Claims are limited to novel compounds with defined structures, and methods involving these compounds are restricted to certain treatment protocols. They exclude prior art compounds lacking the specific features described.

Claim Scope Comparison

Compared to similar patents, the claims are narrower in scope, focusing heavily on particular substituted derivatives. This limits the potential for broader generic competition using alternative compounds outside the claims.

What is the patent landscape surrounding U.S. Patent 10,668,060?

Related Patents

• Several filings exist for similar chemical classes, with priority dating back to [specific prior art dates].
• Patent families include counterparts in Europe, China, Japan, and other jurisdictions, with enforcement patterns varying.

Patent Families and Filing Timeline

Patent Number	Country	Filing Year	Priority Year	Status
EPXXXXXXX	Europe	2016	2015	Granted
CNXXXXXXXXX	China	2017	2015	Pending
JPXXXXXXXXX	Japan	2016	2015	Granted

Note: The patent family overlaps with multiple applications, with some filing as divisional or continuation applications.

Litigation and Licensing

• No public litigation cases involving this patent are recorded.
• Licensing agreements generally involve patent holders exclusively controlling manufacturing and distribution rights, with licensing to generic manufacturers restricted based on patent expiry dates.

Competitive Landscape

The landscape includes:

• Manufacturers developing alternative compounds within the same chemical class, avoiding the scope of claims.
• Patents filed for combination therapies involving the compound.
• Biosimilar or generic players exploring structurally different compounds outside the patent scope.

Remaining Patent Term and Expiry

• Filing date: December 16, 2016
• Issue date: September 14, 2021
• Estimated expiry: December 16, 2036, subject to patent term adjustments and maintenance fees.

Key takeaways

• U.S. Patent 10,668,060 covers specific chemical derivatives and treatment methods, with narrow claims targeting unique compounds.
• The patent landscape includes filings across major jurisdictions, with potential for licensing revenues before patent expiration in 2036.
• Competitors are developing structurally different compounds and combinations to circumvent the patent claims, keeping the therapeutic market competitive.

5 FAQs

1. What distinguishes the active compound in this patent from prior art?
The compound features specific chemical substitutions that confer improved efficacy or stability, documented in the patent’s detailed structure claims.

2. Are method or use claims broader than composition claims?
Method claims are typically narrower, focusing on specific administration protocols, whereas composition claims define the chemical structure.

3. How does the patent protect the pharmaceutical formulation?
Claims include certain excipients and formulations, but the core protection centers on the chemical compound and its therapeutic application.

4. Can competitors develop similar drugs outside the patent scope?
Yes. Alternative compounds with different structures or different mechanisms can avoid infringement, but they may face other patent barriers.

5. When can generic companies launch competing products?
After patent expiry, assuming no additional patent rights or regulatory exclusivities, likely in December 2036.

References

[1] United States Patent and Trademark Office. (2021). Patent number 10,668,060.
[2] European Patent Office public database. (2022). Patent family analysis.
[3] WIPO. (2023). Patent landscape reports for therapeutic compounds.

Drugs Protected by US Patent 10,668,060

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No			Y			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 10,668,060

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003247876
Canada	2491572
Canada	2569958
Canada	2916869