OXAYDO Drug Patent Profile

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Which patents cover Oxaydo, and what generic alternatives are available?

Oxaydo is a drug marketed by Zyla and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in six countries.

The generic ingredient in OXAYDO is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oxaydo

A generic version of OXAYDO was approved as oxycodone hydrochloride by SPECGX LLC on June 30^th, 2004.

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Summary for OXAYDO

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OXAYDO
What excipients (inactive ingredients) are in OXAYDO?	OXAYDO excipients list
DailyMed Link:	OXAYDO at DailyMed

Drug patent expirations by year for OXAYDO

Recent Clinical Trials for OXAYDO

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

Sponsor	Phase
Stanford University	Phase 3

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Pharmacology for OXAYDO

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for OXAYDO

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXAYDO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXAYDO	Tablets	oxycodone hydrochloride	5 mg and 7.5 mg	202080	1	2012-02-07

US Patents and Regulatory Information for OXAYDO

OXAYDO is protected by two US patents.

Patents protecting OXAYDO

Methods and compositions for deterring abuse of opioid containing dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Abuse deterrent compositions and methods of making same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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

Expired US Patents for OXAYDO

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OXAYDO

See the table below for patents covering OXAYDO around the world.

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Country	Patent Number	Title	Estimated Expiration
Israel	175863	PHARMACEUTICAL COMPOSITIONS FOR DETERRING ABUSE OF OPIOID CONTAINING DOSAGE FORMS	⤷ Try a Trial
Australia	2013206525	Methods and compositions for deterring abuse of opioid containing dosage forms	⤷ Try a Trial
European Patent Office	2402004	Procédés et compositions permettant d'empêcher l'abus d'opioïde dans les formes galéniques (Methods and compositions for deterring abuse of opioid containing dosage forms)	⤷ Try a Trial
Australia	2015264950	Methods and compositions for deterring abuse of opioid containing dosage forms	⤷ Try a Trial
European Patent Office	2420225	Procédés et compositions permettant d'empêcher l'abus d'opioïde contenant des formes de dosage (Methods and compositions for deterring abuse of opioid containing dosage forms)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2005053587		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OXAYDO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg	⤷ Try a Trial	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