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Generated: September 23, 2018

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Details for New Drug Application (NDA): 207621

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NDA 207621 describes TROXYCA ER, which is a drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TROXYCA ER profile page.

The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.
Summary for 207621
Generic Entry Opportunity Date for 207621
Generic Entry Date for 207621*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength1.2MG;10MG
Approval Date:Aug 19, 2016TE:RLD:No
Regulatory Exclusivity Expiration:Aug 19, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Sign UpPatent Expiration:Dec 12, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 3, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED

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