TARGINIQ Drug Patent Profile

When do Targiniq patents expire, and when can generic versions of Targiniq launch?

Targiniq is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are fifteen patents protecting this drug.

This drug has three hundred and five patent family members in forty-four countries.

The generic ingredient in TARGINIQ is naloxone hydrochloride; oxycodone hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the naloxone hydrochloride; oxycodone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Targiniq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 4, 2023. This may change due to patent challenges or generic licensing.

There have been twenty-six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TARGINIQ

International Patents:	305
US Patents:	15
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	10
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TARGINIQ
What excipients (inactive ingredients) are in TARGINIQ?	TARGINIQ excipients list
DailyMed Link:	TARGINIQ at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TARGINIQ

NDA:

205777

Dosage:

TABLET, 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.

Anatomical Therapeutic Chemical (ATC) Classes for TARGINIQ

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for TARGINIQ

TARGINIQ is protected by fifteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TARGINIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No			Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No			Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No			Y	Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No

Expired US Patents for TARGINIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014

International Patents for TARGINIQ

When does loss-of-exclusivity occur for TARGINIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Finland

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TARGINIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2002305559
Malaysia	154985	OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE
South Korea	20130020962	PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE
Spain	2415876

Supplementary Protection Certificates for TARGINIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	CA 2013 00052	Denmark		PRODUCT NAME: KOMBINATION AF OXYCODON SOM KOMPONENT A OG NALOXON SOM KOMPONENT B, HERUNDER OXYCODONHYDROCHLORID OG NALOXONHYDROCHLORIDDIHYDRAT; NAT. REG. NO/DATE: 43673, 43674 20081117; FIRST REG. NO/DATE: DE 64537.00.00, 64538.00.00, 64540.00.00, 64541.00.00 20060530
1685839	122013000082	Germany		PRODUCT NAME: KOMBINATION VON OXYCODON ALS KOMPONENTE A UND NALOXON ALS KOMPONENTE B IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 73083.00.00 73084.00.00 73085.00.00 73086.00.00 20060530
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
1685839	C300619	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN OXYCODON ALS COMPONENT A EN NALOXON ALS COMPONENT B IN ALLE VORMEN ZOALS DEZE DOOR HET BASIS OCTROOI ONDER BESCHERMING WORDEN GESTELD; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 20060530