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Last Updated: March 28, 2024

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, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Cypress Pharm Inc, Specgx Llc, Ucb Inc, Ascher, Abhai Llc, Able, Actavis Labs Fl Inc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Granules, Halsey, Lannett Co Inc, Mutual Pharm, Nostrum Labs Inc, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Abana, Ortho Mcneil Pharm, Abbott, and Abbvie, and is included in one hundred and fifty NDAs. Additional information is available in the individual branded drug profile pages.

Forty-one suppliers are listed for this compound.

Summary for acetaminophen; hydrocodone bitartrate
US Patents:0
Tradenames:21
Applicants:53
NDAs:150
Finished Product Suppliers / Packagers: 41
Clinical Trials: 8
DailyMed Link:acetaminophen; hydrocodone bitartrate at DailyMed
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
Teva Branded Pharmaceutical Products, R&D Inc.Phase 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
Caraco HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 090265-002 Dec 23, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040094-004 Mar 22, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cypress Pharm Inc ZYFREL acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 090468-001 Apr 14, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vintage Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 089831-001 Sep 7, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 207709-003 Sep 13, 2018 AA RX 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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