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Last Updated: May 31, 2023

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, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, Dava Pharms Inc, Pharm Assoc, Wockhardt Bio Ag, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, 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:	48
NDAs:	108
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
DailyMed Link:	ACETAMINOPHEN; CODEINE PHOSPHATE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; CODEINE PHOSPHATE

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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

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
Nostrum Labs Inc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	088629-003	Mar 6, 1985	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Specgx Llc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040419-001	May 31, 2001	AA	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Superpharm	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089183-001	Oct 18, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Halsey	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	083871-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089990-001	Sep 30, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duramed Pharms Barr	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	088354-001	Feb 6, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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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