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Last Updated: January 26, 2020

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ACETAMINOPHEN AND CODEINE PHOSPHATE Drug Profile

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When do Acetaminophen And Codeine Phosphate patents expire, and when can generic versions of Acetaminophen And Codeine Phosphate launch?

Acetaminophen And Codeine Phosphate is a drug marketed by Teva, Aci Healthcare Ltd, Actavis Mid Atlantic, Anda Repository, Dava Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, 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, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vintage Pharms, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, and Whiteworth Town Plsn. and is included in ninety-one NDAs.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

Summary for ACETAMINOPHEN AND CODEINE PHOSPHATE

US Patents:	0
Applicants:	40
NDAs:	91
Suppliers / Packagers:	35
Clinical Trials:	1
Formulation / Manufacturing:	see details
DailyMed Link:	ACETAMINOPHEN AND CODEINE PHOSPHATE at DailyMed

Drug patent expirations by year for ACETAMINOPHEN AND CODEINE PHOSPHATE

Recent Clinical Trials for ACETAMINOPHEN AND CODEINE PHOSPHATE

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

Sponsor	Phase
Roxane Laboratories	Phase 1

See all ACETAMINOPHEN AND CODEINE PHOSPHATE clinical trials

Pharmacology for ACETAMINOPHEN AND CODEINE PHOSPHATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

US Patents and Regulatory Information for ACETAMINOPHEN AND 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
Specgx Llc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040419-001	May 31, 2001	AA	RX	No	Yes	Start Trial	Start Trial				Start Trial
Watson Labs Florida	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	040443-001	Jan 22, 2003		DISCN	No	No	Start Trial	Start Trial				Start Trial
Halsey	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	086549-001	Approved Prior to Jan 1, 1982		DISCN	No	No	Start Trial	Start Trial				Start Trial
Elite Labs Inc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	212418-003	Sep 10, 2019	AA	RX	No	No	Start Trial	Start Trial				Start Trial
Usl Pharma	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	087920-001	Jun 22, 1982		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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