By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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TARGINIQ Drug 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 fifteen patents protecting this drug.
This drug has three hundred and one 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-five 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: | 301 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 6 |
| 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
Generic Entry Date for TARGINIQ*:
Constraining patent/regulatory exclusivity:
NDA:
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.
ATC Classes for TARGINIQ
US Patents and Regulatory Information for 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 | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | DISCN | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | DISCN | Yes | No | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| >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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | Get Started Free | Get Started Free |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | Get Started Free | Get Started Free |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | Get Started Free | Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TARGINIQ
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5107954 | Get Started Free |
| Israel | 182742 | Get Started Free |
| Hungary | 1500214 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TARGINIQ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1685839 | 92292 | Luxembourg | Get Started Free | 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 | Get Started Free | 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 | Get Started Free | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
