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 12, 2019

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Acetaminophen; propoxyphene hydrochloride - Generic Drug Details

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What are the generic drug sources for acetaminophen; propoxyphene hydrochloride and what is the scope of freedom to operate?

Acetaminophen; propoxyphene hydrochloride is the generic ingredient in four branded drugs marketed by Aaipharma Llc, Lederle, Mylan, Sandoz, Vintage Pharms, Watson Labs, and Caraco, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; propoxyphene hydrochloride.

Summary for acetaminophen; propoxyphene hydrochloride
US Patents:0
Tradenames:4
Applicants:7
NDAs:8
Drug Master File Entries: 66
Clinical Trials: 5
DailyMed Link:acetaminophen; propoxyphene hydrochloride at DailyMed
Recent Clinical Trials for acetaminophen; propoxyphene hydrochloride

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SponsorPhase
Mansoura UniversityPhase 1/Phase 2
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all acetaminophen; propoxyphene hydrochloride clinical trials

US Patents and Regulatory Information for acetaminophen; propoxyphene hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; propoxyphene hydrochloride TABLET;ORAL 083689-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; propoxyphene hydrochloride TABLET;ORAL 040139-001 Dec 16, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; propoxyphene hydrochloride TABLET;ORAL 089959-001 Jul 18, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Lederle DOLENE AP-65 acetaminophen; propoxyphene hydrochloride TABLET;ORAL 085100-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; propoxyphene hydrochloride TABLET;ORAL 040507-001 Jul 30, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; propoxyphene hydrochloride TABLET;ORAL 083978-001 Approved Prior to Jan 1, 1982 DISCN No 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

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