ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE - Generic Drug Details
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What are the generic drug 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, Hikma Intl Pharms, Lgm Pharma, Nostrum Labs Inc, Strides Pharma, Actavis Labs Ut Inc, and Valeant, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.Five suppliers are listed for this compound.
Summary for ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 5 |
| DailyMed Link: | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE at DailyMed |
Pharmacology for ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
| Drug Class | Barbiturate Central Nervous System Stimulant Methylxanthine Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
| Physiological Effect | Central Nervous System Stimulation |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nostrum Labs Inc | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 075929-001 | Apr 22, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Able | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 076528-001 | Aug 21, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lgm Pharma | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 076560-002 | Jul 19, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma Intl Pharms | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 075618-001 | Mar 23, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Actavis Labs Ut Inc | FIORICET W/ CODEINE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 020232-001 | Jul 30, 1992 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 215138-001 | Jan 26, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Valeant | PHRENILIN WITH CAFFEINE AND CODEINE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 074911-001 | Aug 22, 2001 | DISCN | 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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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 verification 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.
ISSN: 2162-2639
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