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Last Updated: June 28, 2022

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, Alvogen Pine Brook, 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
Sun Pharma Advanced Research Company LimitedPhase 1
GrĂ¼nenthal GmbHPhase 1
Purdue Pharma LPPhase 2

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
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm VANTRELA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 207975-002 Jan 17, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tris Pharma Inc HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 203839-001 Oct 28, 2014 DISCN 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
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 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 206627-002 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 206627-001 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
Chile 2004002017 FORMA DE DOSIFICACION TERMOFORMADA A PRUEBA DE ABUSO QUE CONTIENE (A) UNO O MAS PRINCIPIOS ACTIVOS SUSCEPTIBLES DE ABUSO, (B) OPCIONALMENTE SUSTANCIAS AUXILIARES, (C) AL MENOS UN POLIMERO SINTETICO O NATURAL DE UN GRUPO DEFINIDO Y (D) OPCIONALMENTE A See Plans and Pricing
Cyprus 1114060 See Plans and Pricing
Brazil 0212020 See Plans and Pricing
Cyprus 1110573 See Plans and Pricing
Hong Kong 1138498 TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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