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FDA Orange Book · active-ingredient family

Naltrexone hydrochloride; oxycodone hydrochloride

Naltrexone hydrochloride; oxycodone hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:TROXYCA ER · NDA 207621

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release

ProductApplicantApplicationTEApproved
TROXYCA ER×6PFIZERNDA 207621—Aug 19, 2016

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7815934Dec 12, 2027in 1 yr 6 mo
Product

Naltrexone hydrochloride; oxycodone hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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