Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

Acetaminophen; hydrocodone bitartrate - Generic Drug Details

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What are the generic sources for acetaminophen; hydrocodone bitartrate and what is the scope of patent protection?

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 Lifesciences, 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, Elite Labs Inc, Epic Pharma Llc, Halsey, Lannett Co Inc, Mutual Pharm, 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, Abana, Ortho Mcneil Pharm, Abbott, and Abbvie, and is included in one hundred and forty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; hydrocodone bitartrate. Sixty-two 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
GrĂ¼nenthal 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
Amneal Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 207137-001 Nov 29, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Alvogen Pine Brook HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 209958-002 Oct 24, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Rhodes Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 202991-003 Apr 12, 2016 AA RX No No   Start Trial   Start Trial   Start Trial
Mallinckrodt HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040084-001 Jun 1, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 207172-003 Jun 22, 2017 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.