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FDA Orange Book · active-ingredient family

Nirmatrelvir; ritonavir

Nirmatrelvir; ritonavir is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:PAXLOVID (COPACKAGED) · NDA 217188

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

2

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
PAXLOVID (COPACKAGED)RLDPFIZERNDA 217188—May 25, 2023

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)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11351149Aug 05, 2041in 15 yr 4 mo
SubstanceProductU-3629
11541034Oct 31, 2041in 15 yr 7 mo
U-3629

Nirmatrelvir; ritonavir — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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