PAXLOVID (COPACKAGED) — FDA application NDA217188
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 | PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | TABLET | ORAL | 150MG;100MG | Prescription | not listed | Yes |
| 002 | PAXLOVID (COPACKAGED) | NIRMATRELVIR; RITONAVIR | TABLET | ORAL | 300MG;100MG | Prescription | not listed | not listed |
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 11351149 | 001 | listed patent expiry date: 2041-08-05 | drug substance, drug product, U-3629 |
| Patent 11541034 | 001 | listed patent expiry date: 2041-10-31 | U-3629 |
| Exclusivity D-195 | 001 | listed exclusivity date: 2028-01-31 | FDA code as listed |
| Exclusivity NCE | 001 | listed exclusivity date: 2028-05-25 | FDA code as listed |
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
- NIRMATRELVIR; RITONAVIR · 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.