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Last Updated: November 2, 2024

HYDROCODONE BITARTRATE Drug Patent Profile


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Which patents cover Hydrocodone Bitartrate, and what generic alternatives are available?

Hydrocodone Bitartrate is a drug marketed by Alvogen, Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Cerovene Inc, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Lgm Pharma, Acella, Actavis Mid Atlantic, Apozeal Pharms, Ivax Sub Teva Pharms, Nostrum Labs Inc, Padagis Us, Wockhardt Bio Ag, Ani Pharms, Teva, and Mayne Pharma Inc. and is included in one hundred and fifty-five NDAs.

The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.

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Drug patent expirations by year for HYDROCODONE BITARTRATE
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Recent Clinical Trials for HYDROCODONE BITARTRATE

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SponsorPhase
Ohio Third FrontierPhase 1
Charles River LabsPhase 1
National Institute on Drug Abuse (NIDA)Phase 1

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Pharmacology for HYDROCODONE BITARTRATE
Drug ClassOpioid Agonist
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for HYDROCODONE BITARTRATE
Paragraph IV (Patent) Challenges for HYDROCODONE BITARTRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HYSINGLA ER Extended-release Tablets hydrocodone bitartrate 30 mg, 40 mg, 80 mg, and 100 mg 206627 1 2015-05-08
HYSINGLA ER Extended-release Tablets hydrocodone bitartrate 20 mg, 60 mg, and 120 mg 206627 1 2015-04-15
ZOHYDRO ER Extended-release Capsules hydrocodone bitartrate 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg 202880 1 2014-02-26

US Patents and Regulatory Information for 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 Ny HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040757-001 Aug 25, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lgm Pharma HYDROCODONE BITARTRATE AND ASPIRIN aspirin; hydrocodone bitartrate TABLET;ORAL 205479-001 May 28, 2021 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cerovene Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 211690-002 Feb 7, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms Ny HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-002 Mar 18, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abhai Llc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 209037-001 Jun 21, 2017 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharm Assoc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate SOLUTION;ORAL 040834-001 Apr 18, 2008 RX No Yes ⤷  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

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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 verification 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.