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Last Updated: March 28, 2024

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, Apozeal Pharms, Mayne Pharma Inc, Padagis Us, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrocodone bitartrate has three hundred and eighty-two 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

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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
⤷  Try a Trial⤷  Try a Trial40MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a Trial10MGCAPSULE, 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 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
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 DISCN Yes 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

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 206627-002 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HYDROCODONE BITARTRATE

Country Patent Number Title Estimated Expiration
Chile 2017000669 Forma de dosificación farmacéutica (divisional de la solicitud 1029/2014) ⤷  Try a Trial
Japan 2016222698 オピオイド鎮痛薬を含む不正改変抵抗性経口医薬剤形 (TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING OPIOID ANALGESIC) ⤷  Try a Trial
Hong Kong 1107930 ORAL DOSAGE FORM SAFEGUARDED AGAINST ABUSE ⤷  Try a Trial
Japan 2017527629 乱用抵抗性医薬組成物 ⤷  Try a Trial
Croatia P20110130 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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