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XTAMPZA ER Drug Patent Profile

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Which patents cover Xtampza Er, and when can generic versions of Xtampza Er launch?

Xtampza Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in XTAMPZA ER is oxycodone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxycodone profile page.

DrugPatentWatch^® Generic Entry Outlook for Xtampza Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2036. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (oxycodone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for XTAMPZA ER

International Patents:	24
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	2
Patent Applications:	3,901
Drug Prices:	Drug price information for XTAMPZA ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTAMPZA ER
DailyMed Link:	XTAMPZA ER at DailyMed

Drug patent expirations by year for XTAMPZA ER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XTAMPZA ER

Generic Entry Date for XTAMPZA ER^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208090 Dosage: CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XTAMPZA ER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
Ajay Wasan, MD, Msc	Phase 4
Collegium Pharmaceutical, Inc.	Phase 4

See all XTAMPZA ER clinical trials

Pharmacology for XTAMPZA ER

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for XTAMPZA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTAMPZA ER	Extended-release Capsules	oxycodone	9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg	208090	1	2017-11-15

US Patents and Regulatory Information for XTAMPZA ER

XTAMPZA ER is protected by twelve US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XTAMPZA ER is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XTAMPZA ER

Tamper-resistant pharmaceutical compositions of opioids and other drugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Process of making stable abuse-deterrent oral formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Abuse-deterrent pharmaceutical compositions of opiods and other drugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Abuse-deterrent drug formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Abuse-deterrent pharmaceutical compositions of opioids and other drugs
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Abuse-deterrent drug formulations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for XTAMPZA ER

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for XTAMPZA ER

See the table below for patents covering XTAMPZA ER around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1594467	COMPOSITIONS PHARMACEUTIQUES D'OPIOIDES ET D'AUTRES MEDICAMENTS EMPECHANTS LES UTILISATIONS ABUSIVES (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIOIDS AND OTHER DRUGS)	⤷ Sign Up
Denmark	1765292		⤷ Sign Up
Cyprus	1119831		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for XTAMPZA ER

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description