Last Updated: November 8, 2026

Hydrocodone bitartrate - Generic Drug Details

Name: hydrocodone bitartrate Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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, Knoa Pharma, Teva Branded Pharm, Strides Pharma, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Sun Pharm Inds Inc, Teva, Abbvie, Alpharma Us Pharms, Mayne Pharma Inc, Padagis Us, Pharmazone, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for hydrocodone bitartrate

International Patents:	365
US Patents:	38
Tradenames:	11
Applicants:	18
NDAs:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	31
Drug Prices:	Drug price trends for hydrocodone bitartrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydrocodone bitartrate
What excipients (inactive ingredients) are in hydrocodone bitartrate?	hydrocodone bitartrate excipients list
DailyMed Link:	hydrocodone bitartrate at DailyMed

See drug prices for hydrocodone bitartrate

Recent Clinical Trials for hydrocodone bitartrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	PHASE1
Quivive Pharma, Inc.	PHASE1
Ohio Third Frontier	Phase 1

See all hydrocodone bitartrate clinical trials

Generic filers with tentative approvals for HYDROCODONE BITARTRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	40MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Start Trial	⤷ Start Trial	10MG	CAPSULE, 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 Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Medical Subject Heading (MeSH) Categories for hydrocodone bitartrate

Analgesics, Opioid
Antitussive Agents
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for hydrocodone bitartrate

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

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

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Glossary

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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	202880-003	Oct 25, 2013		DISCN	Yes	No	9,132,096	⤷ Start Trial	Y			⤷ Start Trial
Ani Pharms	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	077454-001	Jun 23, 2010		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No	9,339,499	⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	8,551,520	⤷ Start Trial
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	9,682,077	⤷ Start Trial
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	9,060,940	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for hydrocodone bitartrate

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Country	Patent Number	Title	Estimated Expiration
Canada	2872677	TRAITEMENT DE LA DOULEUR CHEZ DES PATIENTS SOUFFRANT DE DEFICIENCE HEPATIQUE (TREATING PAIN IN PATIENTS WITH HEPATIC IMPAIRMENT)	⤷ Start Trial
China	103904260	Electronic Device	⤷ Start Trial
China	105759918	电子设备 (Electronic device)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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