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Oxycodone - Generic Drug Details

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What are the generic drug sources for oxycodone and what is the scope of patent protection?

Oxycodone is the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Akorn, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Sun Pharm Inds Inc, Vintage Pharms, and Ohemo Life, and is included in fifty-three NDAs. There are forty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Oxycodone has twenty-four patent family members in thirteen countries.

There are nineteen drug master file entries for oxycodone. One supplier is listed for this compound. There are four tentative approvals for this compound.

Summary for oxycodone

International Patents:	24
US Patents:	46
Tradenames:	6
Applicants:	32
NDAs:	53
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	488
Patent Applications:	7,664
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for oxycodone
Drug Sales Revenues:	Drug sales revenues for oxycodone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxycodone
What excipients (inactive ingredients) are in oxycodone?	oxycodone excipients list
DailyMed Link:	oxycodone at DailyMed

See drug prices for oxycodone

See drug sales revenues for oxycodone

Recent Clinical Trials for oxycodone

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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
George Clinical Pty Ltd	Phase 3
Medlab Clinical	Phase 3

See all oxycodone clinical trials

Generic filers with tentative approvals for OXYCODONE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL
		80MG	TABLET, EXTENDED RELEASE; ORAL
		40MG	TABLET, 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 oxycodone

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for oxycodone

Analgesics, Opioid

Narcotics

Paragraph IV (Patent) Challenges for OXYCODONE

Tradename	Dosage	Ingredient	NDA	Submissiondate
XTAMPZA ER	CAPSULE, EXTENDED RELEASE;ORAL	oxycodone	208090	2017-11-15

US Patents and Regulatory Information for oxycodone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	076636-003	Apr 7, 2015		DISCN	No	No
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No			Y
Nuvo Pharm	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	207119-001	Apr 12, 2016	AB	RX	No	No
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	204021-003	Jun 12, 2017	AB	RX	No	No
Eywa	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	209897-001	Sep 6, 2017	AA	RX	No	No
Lannett Co Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	203823-001	Aug 1, 2014		DISCN	No	No

International Patents for oxycodone

Country	Patent Number	Estimated Expiration
Slovenia	1765292
Canada	2916869
Japan	2015166402
Canada	2569958
Japan	4694207
Japan	2009298822

Supplementary Protection Certificates for oxycodone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE