FDA Orange Book
Is there a generic for Paxlovid (copackaged)?
Paxlovid (copackaged) contains nirmatrelvir and ritonavir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Paxlovid (copackaged) (nirmatrelvir and ritonavir). The Orange Book shows its last listed patent expires October 31, 2041 and its last listed exclusivity ends May 25, 2028.
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Paxlovid (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG;100MG | Marketed (Rx) | None | 0 | None |
NDA 217188, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Paxlovid (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11351149 | August 5, 2041 | Drug substance, Drug product | U-3629 | 217188 |
| 11541034 | October 31, 2041 | Method of use | U-3629 | 217188 |
Paxlovid (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| D-195 | New dosing schedule | January 31, 2028 | 217188 |
| NCE | New chemical entity | May 25, 2028 | 217188 |
Questions
Is there a generic for Paxlovid (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Paxlovid (copackaged) (nirmatrelvir and ritonavir). The Orange Book shows its last listed patent expires October 31, 2041 and its last listed exclusivity ends May 25, 2028.
What is the generic name for Paxlovid (copackaged)?
The active ingredient in Paxlovid (copackaged) is nirmatrelvir and ritonavir, per the FDA Orange Book.
When does the Paxlovid (copackaged) patent expire?
The last patent listed for Paxlovid (copackaged) in the Orange Book expires October 31, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.