TROXYCA ER — FDA application NDA207621
Listed sponsor: PFIZER · PFE company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 1.2MG;10MG | Discontinued | not listed | No |
| 002 | TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 2.4MG;20MG | Discontinued | not listed | No |
| 003 | TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 3.6MG;30MG | Discontinued | not listed | No |
| 004 | TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 4.8MG;40MG | Discontinued | not listed | No |
| 005 | TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 7.2MG;60MG | Discontinued | not listed | No |
| 006 | TROXYCA ER | NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 9.6MG;80MG | Discontinued | not listed | No |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 7815934 | 001 | listed patent expiry date: 2027-12-12 | drug product |
| Patent 7815934 | 002 | listed patent expiry date: 2027-12-12 | drug product |
| Patent 7815934 | 003 | listed patent expiry date: 2027-12-12 | drug product |
| Patent 7815934 | 004 | listed patent expiry date: 2027-12-12 | drug product |
| Patent 7815934 | 005 | listed patent expiry date: 2027-12-12 | drug product |
| Patent 7815934 | 006 | listed patent expiry date: 2027-12-12 | drug product |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE · UNII not resolved · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.