➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Express Scripts
Boehringer Ingelheim
Harvard Business School
Dow

Last Updated: October 27, 2020

DrugPatentWatch Database Preview

Hydrocodone bitartrate - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, 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 Labs Llc, Torrent, and Tris Pharma Inc, and is included in nineteen NDAs. There are fifty-seven 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-nine 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

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
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
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-001 Oct 25, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Persion ZOHYDRO ER hydrocodone bitartrate CAPSULE, EXTENDED RELEASE;ORAL 202880-002 Oct 25, 2013 AB RX Yes No   Start Trial   Start Trial Y   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
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No   Start Trial   Start Trial   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 206627-003 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
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-006 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

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

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Boehringer Ingelheim
Dow
Mallinckrodt
Johnson and Johnson

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.