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Last Updated: September 24, 2021

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Hydrocodone bitartrate - Generic Drug Details

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

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

Hydrocodone bitartrate has six hundred and twelve patent family members in forty-nine countries.

There are twenty-three 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
⤷  Free Forever Trial⤷  Free Forever Trial40MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever 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 NDA Submissiondate
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-05-08
HYSINGLA ER TABLET, EXTENDED RELEASE;ORAL hydrocodone bitartrate 206627 2015-04-15
ZOHYDRO ER CAPSULE, EXTENDED RELEASE;ORAL hydrocodone bitartrate 202880 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
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-005 Oct 25, 2013 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Persion REZIRA hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 022442-001 Jun 8, 2011 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Tris Pharma Inc HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 203839-001 Oct 28, 2014 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 206627-003 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Boehringer Ingelheim
Dow
Mallinckrodt
Johnson and Johnson

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