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Last Updated: March 29, 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
Genus HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 040894-001 Jul 19, 2011 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc ANEXSIA 5/325 acetaminophen; hydrocodone bitartrate TABLET;ORAL 040409-001 Oct 20, 2000 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040656-001 Jan 19, 2006 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vintage Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040144-001 Feb 22, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mikart HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 081226-001 Oct 27, 1992 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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