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Last Updated: July 12, 2020

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Acetaminophen; hydrocodone bitartrate - Generic Drug Details

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

Acetaminophen; hydrocodone bitartrate is the generic ingredient in twenty-one branded drugs marketed by Cent Pharms, Ivax Pharms, Forest Pharms, Mallinckrodt, Mikart, Anda Repository, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Vintage Pharms, Vistapharm, Wes Pharma Inc, Cypress Pharm Inc, Specgx Llc, Ucb Inc, Ascher, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen Pine Brook, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Epic Pharma Llc, Granules Pharms, Halsey, Lannett Co Inc, Mutual Pharm, Nostrum Labs Inc, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Tris Pharma Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Xiromed, Abana, Ortho Mcneil Pharm, Abbott, and Abbvie, and is included in one hundred and forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; hydrocodone bitartrate. Forty-eight suppliers are listed for this compound.

Summary for acetaminophen; hydrocodone bitartrate
Recent Clinical Trials for acetaminophen; hydrocodone bitartrate

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

SponsorPhase
Sun Pharma Advanced Research Company LimitedPhase 1
Grünenthal GmbHPhase 1
INC ResearchPhase 3

See all acetaminophen; hydrocodone bitartrate clinical trials

Pharmacology for acetaminophen; hydrocodone bitartrate
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists

US Patents and Regulatory Information for acetaminophen; hydrocodone bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 206142-001 Nov 14, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Vintage Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040143-001 Feb 22, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Pharms ALLAY acetaminophen; hydrocodone bitartrate CAPSULE;ORAL 089907-001 Jan 13, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Apil NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-003 Sep 12, 2000 AA RX No Yes   Start Trial   Start Trial   Start Trial
Ascher HY-PHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 087677-001 May 3, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040356-001 May 31, 2000 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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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Moodys
Harvard Business School
Colorcon
Baxter

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