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Generated: November 16, 2018

DrugPatentWatch Database Preview

XTAMPZA ER Drug 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 fourteen patents protecting this drug and one Paragraph IV challenge.

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

Drug patent expirations by year for XTAMPZA ER
Generic Entry Opportunity Date for XTAMPZA ER
Generic Entry Date for XTAMPZA ER*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for XTAMPZA ER
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for XTAMPZA ER

US Patents and Regulatory Information for XTAMPZA ER

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 208090-005 Apr 26, 2016 RX Yes Yes ➤ 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 208090-003 Apr 26, 2016 RX Yes No ➤ 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

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Paragraph IV (Patent) Challenges for XTAMPZA ER
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Capsules 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for XTAMPZA ER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
292 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Julphar
Chinese Patent Office
Harvard Business School
US Army
Healthtrust
Baxter
QuintilesIMS
Colorcon

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