Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - Generic Drug Details

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

Morphine sulfate; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Morphine sulfate; naltrexone hydrochloride has seventy-one patent family members in twenty-three countries.

There are twenty-three drug master file entries for morphine sulfate; naltrexone hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

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SponsorPhase
PfizerPhase 4
PfizerPhase 3
Ranbaxy Inc.Phase 1

See all MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE clinical trials

Recent Litigation for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

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District Court Litigation
Case NameDate
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Endo Pharmaceuticals Inc. v. Actavis Inc.2012-12-11
Shire LLC, Supernus Pharmaceuticals, Incl v. IMPAX Laboratories, Inc.2010-12-02

See all MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE litigation

Pharmacology for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2018-08-16
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2010-05-28
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2010-05-25
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2010-05-03

US Patents and Regulatory Information for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-006 Aug 13, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-004 Aug 13, 2009   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009   Start Trial   Start Trial
>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 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.