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Generated: October 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208090

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NDA 208090 describes XTAMPZA ER, which is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from two suppliers. There are fourteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XTAMPZA ER profile page.

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.
Summary for 208090
Tradename:XTAMPZA ER
Applicant:Collegium Pharm Inc
Ingredient:oxycodone
Patents:14
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 208090
Generic Entry Date for 208090*:
Constraining patent/regulatory exclusivity:
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 NDA: 208090
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 208090
Suppliers and Packaging for NDA: 208090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 NDA Collegium Pharmaceutical, Inc. 24510-110 24510-110-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-110-10)
XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090 NDA Collegium Pharmaceutical, Inc. 24510-110 24510-110-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-110-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength9MG
Approval Date:Apr 26, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 26, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Dec 10, 2030Product Flag?YSubstance Flag?Delist Request?
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:➤ Try a Free TrialPatent Expiration:Mar 24, 2025Product Flag?YSubstance Flag?Delist Request?

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