Details for New Drug Application (NDA): 217188
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NDA 217188 describes PAXLOVID (COPACKAGED), which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PAXLOVID (COPACKAGED) profile page.
The generic ingredient in PAXLOVID (COPACKAGED) is nirmatrelvir; ritonavir. One supplier is listed for this compound. Additional details are available on the nirmatrelvir; ritonavir profile page.
The generic ingredient in PAXLOVID (COPACKAGED) is nirmatrelvir; ritonavir. One supplier is listed for this compound. Additional details are available on the nirmatrelvir; ritonavir profile page.
Summary for 217188
| Tradename: | PAXLOVID (COPACKAGED) |
| Applicant: | Pfizer |
| Ingredient: | nirmatrelvir; ritonavir |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217188
Generic Entry Date for 217188*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 217188
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PAXLOVID (COPACKAGED) | nirmatrelvir; ritonavir | TABLET;ORAL | 217188 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0521 | 0069-0521-11 | 1 BLISTER PACK in 1 CARTON (0069-0521-11) / 1 KIT in 1 BLISTER PACK * 6 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-06) * 5 TABLET, FILM COATED in 1 BLISTER PACK (0069-1735-05) |
| PAXLOVID (COPACKAGED) | nirmatrelvir; ritonavir | TABLET;ORAL | 217188 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-5045 | 0069-5045-30 | 10 BLISTER PACK in 1 CARTON (0069-5045-30) / 1 KIT in 1 BLISTER PACK (0069-5045-06) * 2 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1345-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;100MG | ||||
| Approval Date: | May 25, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 25, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 31, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW DOSING RECOMMENDATIONS IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDINGTHOSE REQUIRING HEMODIALYSIS BASED ON DATA FROM STUDY C4671028 | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 5, 2041 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF MILD-TO-MODERATE CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH | ||||||||
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