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 eleven branded drugs marketed by Alvogen, Recro Gainesville, Purdue Pharma Lp, Teva Branded Pharm, Nostrum Labs Inc, 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, Sciegen Pharms Inc, Tris Pharma Inc, and Persion, and is included in nineteen NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Hydrocodone bitartrate has three hundred and eighty-two patent family members in forty-nine countries.

There are sixteen drug master file entries for hydrocodone bitartrate. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for HYDROCODONE BITARTRATE

International Patents:	382
US Patents:	39
Tradenames:	11
Applicants:	18
NDAs:	19
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	30
Patent Applications:	457
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
Charles River Labs	Phase 1
National Institute on Drug Abuse (NIDA)	Phase 1
Elysium Therapeutics, Inc.	Phase 1

See all HYDROCODONE BITARTRATE clinical trials

Generic filers with tentative approvals for HYDROCODONE BITARTRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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	202880-005	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-003	Jan 17, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-006	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Recro Gainesville	ZOHYDRO ER	hydrocodone bitartrate	CAPSULE, EXTENDED RELEASE;ORAL	202880-005	Oct 25, 2013		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alvogen	HYDROCODONE BITARTRATE	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	208269-003	Mar 1, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	⤷ Sign Up	⤷ Sign Up
>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
Serbia	51678	FARMACEUTSKI DOZNI OBLICI REZISTENTNI NA ZLOUPOTREBU KOJI SADRŽE OPIOIDNI ANALGETIK (TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC)	⤷ Sign Up
Brazil	122016004010	forma farmacêutica oral sólida de liberação prolongada	⤷ Sign Up
Australia	2015246094	Encased tamper resistant controlled release dosage forms	⤷ Sign Up
Slovenia	2070538		⤷ Sign Up
South Korea	20090045381	TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC	⤷ Sign Up
Malaysia	146650	TAMPER RESISTANT ORAL PHARMACEUTICAL DOSAGE FORMS COMPRISING AN OPIOID ANALGESIC	⤷ Sign Up
Austria	11571		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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