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Last Updated: November 21, 2024

ACETAMINOPHEN; CODEINE PHOSPHATE - Generic Drug Details

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

Acetaminophen; codeine phosphate is the generic ingredient in seventeen branded drugs marketed by Teva, Robins Ah, Solvay, Ortho Mcneil Pharm, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Strides Pharma, Wockhardt Bio Ag, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, and Janssen Pharms, and is included in one hundred and eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-one suppliers are listed for this compound.

Summary for ACETAMINOPHEN; CODEINE PHOSPHATE

US Patents:	0
Tradenames:	17
Applicants:	47
NDAs:	108
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Patent Applications:	501
DailyMed Link:	ACETAMINOPHEN; CODEINE PHOSPHATE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; CODEINE PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Roxane Laboratories	Phase 1

See all ACETAMINOPHEN; CODEINE PHOSPHATE clinical trials

Pharmacology for ACETAMINOPHEN; CODEINE PHOSPHATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; CODEINE PHOSPHATE

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for ACETAMINOPHEN; CODEINE PHOSPHATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	TYLENOL W/ CODEINE NO. 1	acetaminophen; codeine phosphate	TABLET;ORAL	085055-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Mid Atlantic	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	085861-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roxane	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089511-001	Apr 25, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Elite Labs Inc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	212418-002	Sep 10, 2019	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	085868-001	Approved Prior to Jan 1, 1982		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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