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Last Updated: November 12, 2024

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 one supplier. There are twelve 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. One supplier is 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:12
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Patent:⤷  Sign UpPatent 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:⤷  Sign UpPatent Expiration:Sep 2, 2036Product 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:⤷  Sign UpPatent Expiration:Sep 2, 2036Product 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

Expired US Patents for NDA 208090

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 ⤷  Sign Up ⤷  Sign Up
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
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-005 Apr 26, 2016 ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.