ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for acetaminophen; oxycodone hydrochloride and what is the scope of freedom to operate?

Acetaminophen; oxycodone hydrochloride is the generic ingredient in twelve branded drugs marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Roxane, Janssen Pharms, Ortho Mcneil Pharm, Abhai Llc, Mikart, Nostrum Labs Inc, Specgx Llc, Endo Operations, Hikma, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in sixty-six NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen; oxycodone hydrochloride has thirty-one patent family members in thirteen countries.

Thirty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

International Patents:	31
US Patents:	12
Tradenames:	12
Applicants:	37
NDAs:	66
Finished Product Suppliers / Packagers:	36
Clinical Trials:	143
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
DailyMed Link:	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Jessyka Lighthall	Phase 3
Universidad Simón Bolívar	Phase 3

See all ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	325MG; 7.5MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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Glossary

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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
Granules	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	211708-003	Oct 31, 2019	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mallinckrodt	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040550-001	Jun 30, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	090734-001	Jul 11, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novel Labs Inc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	204407-003	Feb 24, 2017	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	TYLOX	acetaminophen; oxycodone hydrochloride	CAPSULE;ORAL	088790-001	Dec 12, 1984		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

Expired US Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
China	102105136	Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic	⤷ Sign Up
South Africa	201303988	METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS	⤷ Sign Up
Mexico	2013007057	METODOS PARA PRODUCIR COMPOSICIONES FARMACEUTICAS ESTABILIZADAS DE DOSIS SOLIDA QUE CONTIENEN MORFINANOS. (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS.)	⤷ Sign Up
Japan	5607550		⤷ Sign Up
Mexico	2010009990	FORMAS DE DOSIFICACIÓN GÁSTRICAS RETENTIVAS DE LIBERACIÓN PROLONGADA QUE COMPRENDEN COMBINACIONES DE UN ANALGÉSICO NO OPIOIDE Y UN ANALGÉSICO OPIOIDE. (GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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