OXYCODONE - Generic Drug Details

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

Oxycodone is the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, 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-three NDAs. There are thirty-four 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:	34
Tradenames:	6
Applicants:	33
NDAs:	53
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	575
Patent Applications:	6,467
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OXYCODONE

Generic Entry Date for OXYCODONE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OXYCODONE

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

Sponsor	Phase
Henry Ford Health System	Phase 4
University of Miami	Phase 3
Murdoch Childrens Research Institute	Phase 4

See all OXYCODONE clinical trials

Generic filers with tentative approvals for OXYCODONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	80MG	TABLET, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	80MG	TABLET, EXTENDED RELEASE; ORAL
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for OXYCODONE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXYCODONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTAMPZA ER	Extended-release Capsules	oxycodone	9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg	208090	1	2017-11-15

US Patents and Regulatory Information for OXYCODONE

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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
Sun Pharm Inds Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	090659-002	Apr 10, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	208795-001	Aug 7, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Protega Pharms	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-002	Apr 20, 2017		RX	No	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Ascent Pharms Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	207418-002	Aug 7, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	202662-003	Sep 22, 2015	AB	RX	No	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 OXYCODONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OXYCODONE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017222575		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005123039		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004004693		⤷ Sign Up
Japan	2006500426		⤷ Sign Up
Japan	2009298822	ABUSE-DETERRENT PHARMACEUTICAL COMPOSITION ON OPIOID AND OTHER DRUG	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OXYCODONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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