DrugPatentWatch Database Preview
Email this page to a colleague
« Back to Dashboard
Xtampza Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are nineteen 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.
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
Summary for XTAMPZA ER
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||20|
|Formulation / Manufacturing:||see details|
|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|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XTAMPZA ER
*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
|Ajay Wasan, MD, Msc||Phase 4|
|University of Alabama at Birmingham||Early Phase 1|
|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||Get Started Free||Get Started Free||Y||Get Started Free|
|Collegium Pharm Inc||XTAMPZA ER||oxycodone||CAPSULE, EXTENDED RELEASE;ORAL||208090-003||Apr 26, 2016||RX||Yes||No||Get Started Free||Get Started Free||Y||Get Started Free|
|Collegium Pharm Inc||XTAMPZA ER||oxycodone||CAPSULE, EXTENDED RELEASE;ORAL||208090-002||Apr 26, 2016||RX||Yes||No||Get Started Free||Get Started Free||Y||Get Started Free|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1685839||92292||Luxembourg||Get Started Free||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|