Details for New Drug Application (NDA): 205777
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NDA 205777 describes TARGINIQ, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are two patents protecting this drug. Additional details are available on the TARGINIQ profile page.
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.
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.
Summary for 205777
| Tradename: | TARGINIQ |
| Applicant: | Purdue Pharma Lp |
| Ingredient: | naloxone hydrochloride; oxycodone hydrochloride |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205777
Generic Entry Date for 205777*:
Constraining patent/regulatory exclusivity:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG;10MG | ||||
| Approval Date: | Jul 23, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 9,073,933 | Patent Expiration: | Mar 30, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | 9,522,919 | Patent Expiration: | Mar 30, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG;20MG | ||||
| Approval Date: | Jul 23, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 9,073,933 | Patent Expiration: | Mar 30, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 205777
| 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 | 6,696,066 | ⤷ Subscribe |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-002 | Jul 23, 2014 | 8,969,369 | ⤷ Subscribe |
| Purdue Pharma Lp | TARGINIQ | naloxone hydrochloride; oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205777-003 | Jul 23, 2014 | 9,511,066 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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