Details for New Drug Application (NDA): 205777
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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: | ⤷ Try for Free | Patent Expiration: | Mar 30, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Try for Free | 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: | ⤷ Try for Free | Patent Expiration: | Mar 30, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 205777
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