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Last Updated: July 12, 2020

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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 ten branded drugs marketed by Alvogen, Persion, Purdue Pharma Lp, Teva Branded Pharm, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms Inc, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Vintage Pharms, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Paddock Llc, Torrent, and Tris Pharma Inc, and is included in nineteen NDAs. There are fifty-six 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 fifty-five patent family members in forty-nine countries.

There are twenty-three drug master file entries for hydrocodone bitartrate. Three 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
Sun Pharma Advanced Research Company LimitedPhase 1
Grünenthal 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
  Start Trial  Start Trial40MGCAPSULE, EXTENDED RELEASE;ORAL
  Start Trial  Start 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 206627-002 Nov 20, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm VANTRELA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 207975-002 Jan 17, 2017 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Alvogen HYDROCODONE BITARTRATE hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 206986-002 Jan 21, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Vintage Pharms HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 077723-002 Nov 6, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc HYDROCODONE BITARTRATE AND IBUPROFEN hydrocodone bitartrate; ibuprofen TABLET;ORAL 204575-001 Jun 2, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 RX Yes No   Start Trial   Start Trial Y   Start 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 206627-004 Nov 20, 2014   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-006 Oct 25, 2013   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-004 Oct 25, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Mallinckrodt
Johnson and Johnson
Express Scripts
McKesson

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