➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Mallinckrodt
Johnson and Johnson
Express Scripts
McKesson

Last Updated: October 20, 2021

DrugPatentWatch Database Preview

Hydrocodone bitartrate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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, 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 fourteen 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
Teva Branded Pharm VANTRELA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 207975-004 Jan 17, 2017 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Recro Gainesville ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alvogen Pine Brook HYDROCODONE BITARTRATE hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 208269-003 Mar 1, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  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 206627-006 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
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Mallinckrodt
Johnson and Johnson
Express Scripts
McKesson

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.