Orange Book product · Brand (NDA)
PAXLOVID (COPACKAGED)
NIRMATRELVIR; RITONAVIR
At a glance
May 25, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 25, 2023
3 yr 1 mo ago
Today
Exclusivity ends · D-195
New indication / change exclusivity (3 years)
Jan 31, 2028
in 1 yr 8 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
May 25, 2028
in 2 yr
Patent 11351149 expires
Listed drug substance patent expiration.
Aug 05, 2041
in 15 yr 4 mo
Patent 11541034 expires
Listed method-of-use patent (U-3629) expiration.
Oct 31, 2041
in 15 yr 7 mo
Pharmaceutical detail
Active ingredient
NIRMATRELVIR; RITONAVIR
Strength
150MG;100MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 217188
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- D-195New indication / change exclusivity (3 years)
Jan 31, 2028
in 1 yr 8 mo
- NCENew chemical entity exclusivity (5 years)
May 25, 2028
in 2 yr
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11351149 | Aug 05, 2041 | in 15 yr 4 mo | SubstanceProductU-3629 |
| 11541034 | Oct 31, 2041 | in 15 yr 7 mo | U-3629 |
