Details for New Drug Application (NDA): 207621
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NDA 207621 describes TROXYCA ER, which is a drug marketed by Pfizer and is included in one NDA. There is one patent protecting this drug. Additional details are available on the TROXYCA ER profile page.
The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.
The generic ingredient in TROXYCA ER is naltrexone hydrochloride; oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone hydrochloride; oxycodone hydrochloride profile page.
Summary for 207621
| Tradename: | TROXYCA ER |
| Applicant: | Pfizer |
| Ingredient: | naltrexone hydrochloride; oxycodone hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207621
Generic Entry Date for 207621*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, 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: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 1.2MG;10MG | ||||
| Approval Date: | Aug 19, 2016 | TE: | RLD: | No | |||||
| Patent: | 7,815,934 | Patent Expiration: | Dec 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 2.4MG;20MG | ||||
| Approval Date: | Aug 19, 2016 | TE: | RLD: | No | |||||
| Patent: | 7,815,934 | Patent Expiration: | Dec 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 3.6MG;30MG | ||||
| Approval Date: | Aug 19, 2016 | TE: | RLD: | No | |||||
| Patent: | 7,815,934 | Patent Expiration: | Dec 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 207621
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-005 | Aug 19, 2016 | 8,685,443 | ⤷ Start Trial |
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-003 | Aug 19, 2016 | 8,685,443 | ⤷ Start Trial |
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-001 | Aug 19, 2016 | 8,685,443 | ⤷ Start Trial |
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-004 | Aug 19, 2016 | 8,685,443 | ⤷ Start Trial |
| Pfizer | TROXYCA ER | naltrexone hydrochloride; oxycodone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 207621-006 | Aug 19, 2016 | 8,685,443 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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