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 20, 2019

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Acetaminophen; butalbital; caffeine - Generic Drug Details

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What are the generic sources for acetaminophen; butalbital; caffeine and what is the scope of freedom to operate?

Acetaminophen; butalbital; caffeine is the generic ingredient in ten branded drugs marketed by Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma Pharms, Mallinckrodt, Mayne Pharma Inc, Nexgen Pharma, Nuvo Pharms Inc, Wraser Pharms Llc, Mikart, Us Chem, Abhai Llc, Able, Actavis Labs Ut Inc, Cnty Line Pharms, Lannett Co Inc, Mirror Pharms Llc, Nexgen Pharma Inc, Novast Labs, Specgx Llc, Sun Pharm Industries, Vintage Pharms, Watson Labs, Forest Pharms, Hikma Intl Pharms, and Valeant, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; butalbital; caffeine. Thirty-six suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine
Recent Clinical Trials for acetaminophen; butalbital; caffeine

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SponsorPhase
GlaxoSmithKlinePhase 3

See all acetaminophen; butalbital; caffeine clinical trials

Pharmacology for acetaminophen; butalbital; caffeine

US Patents and Regulatory Information for acetaminophen; butalbital; caffeine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilbert Labs BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 087629-001 Nov 13, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Pharms BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 040336-001 Aug 18, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Graham Dm BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 088765-001 Mar 27, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Cnty Line Pharms BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 204984-001 Jan 10, 2017 AA RX 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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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Dow
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Medtronic
Moodys

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