Oxycodone hydrochloride - Generic Drug Details

What are the generic sources for oxycodone hydrochloride and what is the scope of freedom to operate?

Oxycodone hydrochloride is the generic ingredient in five branded drugs marketed by 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, Chartwell Molecular, 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, Strides Pharma, Sun Pharm Inds Inc, and Protega Pharms, and is included in fifty-two NDAs. There are twenty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxycodone hydrochloride has six hundred patent family members in forty-nine countries.

There are twelve drug master file entries for oxycodone hydrochloride. Forty-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for oxycodone hydrochloride

International Patents:	600
US Patents:	29
Tradenames:	5
Applicants:	32
NDAs:	52
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	552
Patent Applications:	3,021
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxycodone hydrochloride
What excipients (inactive ingredients) are in oxycodone hydrochloride?	oxycodone hydrochloride excipients list
DailyMed Link:	oxycodone hydrochloride at DailyMed

Recent Clinical Trials for oxycodone hydrochloride

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
Wake Forest University Health Sciences	Phase 2/Phase 3
Al-Azhar University	Phase 4

See all oxycodone hydrochloride clinical trials

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE

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 hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for OXYCODONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXAYDO	Tablets	oxycodone hydrochloride	5 mg and 7.5 mg	202080	1	2012-02-07
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	20 mg	022272	2	2010-10-29
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	15 mg	022272	1	2010-10-28
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	10 mg	022272	1	2010-10-25
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	30 mg, 60 mg and 80 mg	022272	1	2010-10-18
OXYCONTIN	Extended-release Tablets	oxycodone hydrochloride	40 mg	022272	1	2010-10-04

US Patents and Regulatory Information for oxycodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	203447-001	Aug 30, 2017		DISCN	No	No
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010		RX	Yes	No			Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010		RX	Yes	No			Y	Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010		RX	Yes	No
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010		RX	Yes	Yes			Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No			Y
Roxane	ROXICODONE	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020932-001	Oct 26, 1998		DISCN	No	No

Expired US Patents for oxycodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-005	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-004	Apr 5, 2010

International Patents for oxycodone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Poland	2305683
Australia	2004264667	Form of administration secured against misuse
Dominican Republic	P2009000026	FORMAS DE DOSIFICACION FARMACEUTICA ORAL RESISTENTE A LA MANIPULACION QUE COMPRENDE UN ANALGESICO OPIOIDE
Croatia	P20130433
China	1917862	Dosage form that is safeguarded from abuse
Cyprus	1119598
Peru	20091184	FORMAS DE DOSIFICACION FARMACEUTICA

Supplementary Protection Certificates for oxycodone hydrochloride

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