Details for New Drug Application (NDA): 217188
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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 | 0069-5317 | 0069-5317-20 | 10 BLISTER PACK in 1 CARTON (0069-5317-20) / 1 KIT in 1 BLISTER PACK (0069-5317-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-11) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1735-11) |
PAXLOVID (COPACKAGED) | nirmatrelvir; ritonavir | TABLET;ORAL | 217188 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-5321 | 0069-5321-30 | 10 BLISTER PACK in 1 CARTON (0069-5321-30) / 1 KIT in 1 BLISTER PACK (0069-5321-03) * 2 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1735-11) |
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 | ||||||||
Patent: | ⤷ Sign Up | 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 | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 31, 2041 | Product Flag? | Substance Flag? | 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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