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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Cipla
Queensland Health
Fuji
Colorcon
Teva
Federal Trade Commission
Farmers Insurance
AstraZeneca
Chubb

Generated: June 27, 2017

DrugPatentWatch Database Preview

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 eighteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.

Summary for NDA: 207621

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength1.2MG;10MG
Approval Date:Aug 19, 2016TE:RLD:No
Patent:7,815,934Patent Expiration:Dec 12, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,685,443Patent 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
Regulatory Exclusivity Expiration:Aug 19, 2019
Regulatory Exclusivity Use:NEW COMBINATION


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Cipla
Julphar
Johnson and Johnson
Express Scripts
Chubb
Citi
Moodys
Novartis
Medtronic

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 verifification 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.

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