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Generated: March 18, 2019

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TROXYCA ER Drug Profile

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When do Troxyca Er patents expire, and what generic alternatives are available?

Troxyca Er is a drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this drug.

This drug has ten patent family members in six countries.

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 TROXYCA ER
International Patents:10
US Patents:2
Applicants:1
NDAs:1
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:TROXYCA ER at DailyMed
Drug patent expirations by year for TROXYCA ER
Generic Entry Opportunity Date for TROXYCA ER
Generic Entry Date for TROXYCA ER*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
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.

Synonyms for TROXYCA ER
850636-71-4
ALO-02
Naltrexone / oxycodone
Naltrexone hydrochloride / oxycodone hydrochloride
Naltrexone hydrochloride and oxycodone hydrochloride
Naltrexone hydrochloride mixture with oxycodone hydrochloride
Oxycodone / naltrexone
Oxycodone hydrochloride / naltrexone hydrochloride
Oxycodone hydrochloride and naltrexone hydrochloride
SequestOx

US Patents and Regulatory Information for TROXYCA ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-001 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-002 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-004 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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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International Patents for TROXYCA ER

Supplementary Protection Certificates for TROXYCA ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 LUC00054 Luxembourg ➤ Try a Free Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 2017C/064 Belgium ➤ Try a Free Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 1790064-8 Sweden ➤ Try a Free Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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QuintilesIMS

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