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Last Updated: February 3, 2023

Hydrocodone bitartrate - Generic Drug Details


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

Hydrocodone bitartrate is the generic ingredient in eleven branded drugs marketed by Alvogen, Recro Gainesville, Purdue Pharma Lp, Teva Branded Pharm, Nostrum Labs Inc, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Padagis Us, Torrent, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are forty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrocodone bitartrate has five hundred and seventy-one patent family members in forty-nine countries.

There are sixteen drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for hydrocodone bitartrate

See drug prices for hydrocodone bitartrate

Recent Clinical Trials for hydrocodone bitartrate

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

SponsorPhase
Elysium Therapeutics, Inc.Phase 1
Medpace, Inc.Phase 1
Ohio Third FrontierPhase 1

See all hydrocodone bitartrate clinical trials

Generic filers with tentative approvals for HYDROCODONE BITARTRATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing40MGCAPSULE, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing10MGCAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrocodone bitartrate
Drug ClassOpioid Agonist
Mechanism of Action Opioid 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
Torrent HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 206661-001 Jan 23, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alvogen HYDROCODONE BITARTRATE hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 208269-004 Mar 1, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for hydrocodone bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for hydrocodone bitartrate

Country Patent Number Title Estimated Expiration
Serbia 52793 FARMACEUTSKI DOZNI OBLICI (PHARMACEUTICAL DOSAGE FORMS) See Plans and Pricing
Canada 2991216 FORMES PHARMACEUTIQUES ENCAPSULEES, INVIOLABLES ET A LIBERATION CONTROLEE (ENCASED TAMPER RESISTANT CONTROLLED RELEASE DOSAGE FORMS) See Plans and Pricing
Brazil PI0714539 "FORMAS FARMACÊUTICAS" See Plans and Pricing
China 107106503 抗滥用药物组合物 (Abuse resistant pharmaceutical compositions) See Plans and Pricing
Croatia P20130434 See Plans and Pricing
Poland 1897545 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.