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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
McKesson
Queensland Health
Novartis
Chinese Patent Office
Citi
Moodys
Fuji
Teva

Generated: February 23, 2018

DrugPatentWatch Database Preview

Naltrexone - Generic Drug Details

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What are the generic sources for naltrexone and what is the scope of naltrexone freedom to operate?

Naltrexone
is the generic ingredient in four branded drugs marketed by Alkermes, Accord Hlthcare, Apotex Inc, Barr, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharma Global, Teva Womens, and Pfizer Inc, and is included in ten NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naltrexone has one hundred and twenty-one patent family members in twenty-seven countries.

There are nineteen drug master file entries for naltrexone. One supplier is listed for this compound.
Summary for naltrexone
Medical Subject Heading (MeSH) Categories for naltrexone

US Patents and Regulatory Information for naltrexone

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 207621-002 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-001 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-004 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Elite Labs NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274-001 May 26, 1999 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-004 Aug 19, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 207905-001 Jul 21, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for naltrexone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction ➤ Sign Up
7,300,671 Method and apparatus for preparing microparticles using in-line solvent extraction ➤ Sign Up
7,510,730 Apparatus and method for preparing microparticles using in-line solvent extraction ➤ Sign Up
6,705,757 Method and apparatus for preparing microparticles using in-line solvent extraction ➤ Sign Up
6,861,016 Apparatus and method for preparing microparticles ➤ Sign Up
7,371,406 Preparation of injectable suspensions having improved injectability ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for naltrexone

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Julphar
Moodys
McKinsey
Covington
Medtronic
AstraZeneca
Express Scripts

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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