TARGINIQ Drug Patent Profile

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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 two patents protecting this drug.

This drug has one hundred and fifty-one patent family members in forty-one 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 March 30, 2025. This may change due to patent challenges or generic licensing.

There have been twenty-eight 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

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Summary for TARGINIQ

International Patents:	151
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	7
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

Drug patent expirations by year for TARGINIQ

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

Generic Entry Date for TARGINIQ^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

US Patents and Regulatory Information for TARGINIQ

TARGINIQ is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TARGINIQ is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Oxycodone compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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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
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ 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 TARGINIQ

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	⤷ Sign Up	⤷ Sign Up
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TARGINIQ

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

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Country	Patent Number	Title	Estimated Expiration
Poland	2319846		⤷ Sign Up
Serbia	54598	POSTUPAK ZA DOBIJANJE KOMPOZICIJA OKSIKODON HIDROHLORIDA SA MANJE OD 25ppm 14-HIDROKSIKODEINONA (PROCESS FOR PREPARING OXYCODONE HYDROCHLORIDE COMPOSITIONS HAVING LESS THAN 25PPM 14-HYDROXYCODEINONE)	⤷ Sign Up
Israel	214050	תכשיר אוקסיקודון הידרוכלוריד המכיל פחות מ-25 חלקים למיליון של 14-הידרוקסיקודאינון ותהליך להכנתו של מלח אוקסיקודון אשר בעיקרו נטול 14-הידרוקסיקודאינון (Oxycodone hydrochloride composition having less than 25 ppm 14-hydroxycodeinone and a process for preparing an oxycodone salt substantially free of 14-hydroxycodeinone)	⤷ Sign Up
South Korea	101200700		⤷ Sign Up
China	1646102	Pharmaceutical preparation containing oxycodone and naloxone	⤷ Sign Up
Germany	60325567		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TARGINIQ

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	122013000082	Germany	⤷ Sign Up	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	⤷ 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
1685839	CA 2013 00052	Denmark	⤷ Sign Up	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	C300619	Netherlands	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description