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PAXLOVID (COPACKAGED) Drug Patent Profile

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Which patents cover Paxlovid (copackaged), and what generic alternatives are available?

Paxlovid (copackaged) is a drug marketed by Pfizer and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-two patent family members in thirty-four countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Paxlovid (copackaged)

Paxlovid (copackaged) will be eligible for patent challenges on May 25, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 25, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PAXLOVID (COPACKAGED)

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
DailyMed Link:	PAXLOVID (COPACKAGED) at DailyMed

Drug patent expirations by year for PAXLOVID (COPACKAGED)

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PAXLOVID (COPACKAGED)

Generic Entry Date for PAXLOVID (COPACKAGED)^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 217188 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.

US Patents and Regulatory Information for PAXLOVID (COPACKAGED)

PAXLOVID (COPACKAGED) is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PAXLOVID (COPACKAGED) is ⤷ Sign Up.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PAXLOVID (COPACKAGED)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

FDA Regulatory Exclusivity protecting PAXLOVID (COPACKAGED)

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PAXLOVID (COPACKAGED)	nirmatrelvir; ritonavir	TABLET;ORAL	217188-001	May 25, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	PAXLOVID (COPACKAGED)	nirmatrelvir; ritonavir	TABLET;ORAL	217188-002	May 25, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	PAXLOVID (COPACKAGED)	nirmatrelvir; ritonavir	TABLET;ORAL	217188-001	May 25, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	PAXLOVID (COPACKAGED)	nirmatrelvir; ritonavir	TABLET;ORAL	217188-001	May 25, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for PAXLOVID (COPACKAGED)

See the table below for patents covering PAXLOVID (COPACKAGED) around the world.

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Country	Patent Number	Title	Estimated Expiration
China	114466838	含腈的抗病毒化合物 (Nitrile-containing antiviral compounds)	⤷ Sign Up
South Africa	202204781	NITRILE-CONTAINING ANTIVIRAL COMPOUNDS	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2021250648		⤷ Sign Up
European Patent Office	3953330	COMPOSÉS ANTIVIRAUX CONTENANT DU NITRILE (NITRILE-CONTAINING ANTIVIRAL COMPOUNDS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration