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Last Updated: April 24, 2024

HYDROCODONE BITARTRATE Drug Patent Profile

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Which patents cover Hydrocodone Bitartrate, and what generic alternatives are available?

Hydrocodone Bitartrate is a drug marketed by Alvogen, Mallinckrodt, Mikart, Chartwell, Genus, Mallinckrodt Inc, Nesher Pharms, Pharm Assoc, Tris Pharma Inc, Vintage Pharms, Wes Pharma Inc, Abhai Llc, Able, Actavis Labs Fl Inc, Amneal Pharms, Amneal Pharms Ny, Apil, Ascent Pharms Inc, Aurolife Pharma Llc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Granules, Halsey, Ivax Pharms, Lannett Co Inc, Mutual Pharm, Nostrum Labs Inc, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Rhodes Pharms, Sandoz, Specgx Llc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Ucb Inc, Upsher Smith Labs, Usl Pharma, Vintage Pharms Llc, Watson Labs, Watson Labs Florida, Lgm Pharma, Acella, Actavis Mid Atlantic, Apozeal Pharms, Ivax Sub Teva Pharms, Padagis Us, Pai Holdings Pharm, Wockhardt Bio Ag, Ani Pharms, Teva, and Mayne Pharma Inc. and is included in one hundred and fifty-five NDAs.

The generic ingredient in HYDROCODONE BITARTRATE is chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride profile page.

Summary for HYDROCODONE BITARTRATE

US Patents:	0
Applicants:	56
NDAs:	155
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	30
Patent Applications:	135
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

Drug patent expirations by year for HYDROCODONE BITARTRATE

Drug Prices for HYDROCODONE BITARTRATE

Recent Clinical Trials for HYDROCODONE BITARTRATE

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

Sponsor	Phase
Ohio Third Frontier	Phase 1
Charles River Labs	Phase 1
National Institute on Drug Abuse (NIDA)	Phase 1

See all HYDROCODONE BITARTRATE clinical trials

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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040757-001	Aug 25, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lgm Pharma	HYDROCODONE BITARTRATE AND ASPIRIN	aspirin; hydrocodone bitartrate	TABLET;ORAL	205479-001	May 28, 2021		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cerovene Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	211690-002	Feb 7, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms Ny	HYDROCODONE BITARTRATE AND IBUPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	076642-002	Mar 18, 2004	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abhai Llc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	209037-001	Jun 21, 2017	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharm Assoc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	SOLUTION;ORAL	040834-001	Apr 18, 2008		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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