Viewing data from:

PAXLOVID (COPACKAGED)

NDA

NIRMATRELVIR; RITONAVIR | N217188 | PFIZER INC

1 strength2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

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2038

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2040

2041

2042

Today

11351149

Aug. 5, 2041

11541034

Oct. 31, 2041

D-195

Jan. 31, 2028

NCE

May. 25, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Enanta Pharmaceuticals, Inc. v. Pfizer Inc. 1:2022cv10967 1 patentnirmatrelvir	D. Mass.	2022-06-21	Terminated 2025-02-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$133.54

per ea

Lowest NADAC/Unit

$49.23

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00069052111PAXLOVID 300/150-100 MG DOSE PACK (SEVERE RENAL DOSE)	$133.54	EA	Brand	—	2026-06-17
00069545011PAXLOVID 300/150-100 MG DOSE PACK (SEVERE RENAL DOSE)	$133.54	EA	Brand	—	2026-06-17
00069543420PAXLOVID 150-100 MG DOSE PACK (MODERATE RENAL DOSE)	$73.82	EA	Brand	—	2026-06-17
00069504530PAXLOVID 300-100 MG DOSE PACK	$49.23	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$1104.39

Highest Price

$1473.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00069-0521-11PAXLOVID 150-100MG DOSE PACK (SEVERE RENAL DO	$1473.58	FSS	Pfizer Inc.	06/30/2029
00069-0521-11PAXLOVID 150-100MG DOSE PACK (SEVERE RENAL DO	$1116.98	Big4	Pfizer Inc.	06/30/2029
00069-5434-20PAXLOVID 150MG/100MG TAB,5-DAY RENAL PACK	$1466.62	FSS	Pfizer Inc.	06/30/2029
00069-5434-20PAXLOVID 150MG/100MG TAB,5-DAY RENAL PACK	$1106.63	Big4	Pfizer Inc.	06/30/2029
00069-5317-20PAXLOVID 150MG/100MG TAB,5-DAY RENAL PACK	$1423.91	FSS	Pfizer Inc.	06/30/2029
00069-5317-20PAXLOVID 150MG/100MG TAB,5-DAY RENAL PACK	$1106.63	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 12, 2026	SUPPL -17	View Letter (PDF)
Feb 12, 2026	SUPPL -16	View Letter (PDF)
Feb 13, 2025	SUPPL -10	View Letter (PDF)
Feb 6, 2025	SUPPL -8	View Letter (PDF)
Nov 21, 2024	SUPPL -9	View Letter (PDF)
Sep 16, 2024	SUPPL -6	View Letter (PDF)
May 25, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG;100MG

RLD

2 patents2 exclusivities▴

TABLET;ORAL | Approved: May 25, 2023

Patents (2) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11351149	Aug 5, 2041	—	Yes	Yes		—
11541034	Oct 31, 2041	—	—	—		—

Exclusivities (2)

Code	Date	Status
D-195	Jan 31, 2028	Active
NCE	May 25, 2028	Active