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Last Updated: December 16, 2019

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Acetaminophen; butalbital; caffeine; codeine phosphate - Generic Drug Details

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What are the generic sources for acetaminophen; butalbital; caffeine; codeine phosphate and what is the scope of patent protection?

Acetaminophen; butalbital; caffeine; codeine phosphate is the generic ingredient in three branded drugs marketed by Able, Hikma Intl Pharms, Nexgen Pharma Inc, Vintage Pharms, Actavis Labs Ut Inc, and Valeant, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for acetaminophen; butalbital; caffeine; codeine phosphate
Pharmacology for acetaminophen; butalbital; caffeine; codeine phosphate

US Patents and Regulatory Information for acetaminophen; butalbital; caffeine; codeine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant PHRENILIN WITH CAFFEINE AND CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 074911-001 Aug 22, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Labs Ut Inc FIORICET W/ CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 020232-001 Jul 30, 1992 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Vintage Pharms BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075929-001 Apr 22, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075618-001 Mar 23, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Nexgen Pharma Inc BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076560-002 Jul 19, 2012 RX No No   Start Trial   Start Trial   Start Trial
Able BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076528-001 Aug 21, 2003 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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