Application 217188

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAXLOVID (COPACKAGED)	NIRMATRELVIR; RITONAVIR	TABLET;ORAL	150MG;100MG	Yes	Yes
002	PAXLOVID (COPACKAGED)	NIRMATRELVIR; RITONAVIR	TABLET;ORAL	300MG;100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217188-001	PAXLOVID (COPACKAGED)	NIRMATRELVIR; RITONAVIR	150MG;100MG	TABLET / ORAL		RLD, RS	2023-05-25

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23
N217188-001	11541034	2041-10-31	U-3629		2023-06-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217188-001	D-195	2028-01-31
N217188-001	NCE	2028-05-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD	2023-05-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217188-002	PAXLOVID (COPACKAGED)	300MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217188-001	PAXLOVID (COPACKAGED)	150MG;100MG	TABLET / ORAL	RLD, RS	2023-05-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-001	11351149	2041-08-05	U-3629	Drug substance, Drug product	2023-06-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-001	11541034	2041-10-31	U-3629		2023-06-23	`a67488948f0b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217188-001	D-195	2028-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217188-001	NCE	2028-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	D-195	2028-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217188-001	NCE	2028-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217188-001	D-195	2028-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217188-001	NCE	2028-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	D-195	2028-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217188-001	NCE	2028-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217188-001	NCE	2028-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217188-001	NCE	2028-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217188-001	NCE	2028-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217188-001	NCE	2028-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217188-001	NCE	2028-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217188-001	NCE	2028-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217188-001	NCE	2028-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-001	NCE	2028-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217188-002	NCE	2028-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-001	NCE	2028-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217188-002	NCE	2028-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217188-001	NCE	2028-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217188-002	NCE	2028-05-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-001	NCE	2028-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217188-002	NCE	2028-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217188-001	NCE	2028-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217188-002	NCE	2028-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217188-001	NCE	2028-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217188-002	NCE	2028-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-001	NCE	2028-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217188-002	NCE	2028-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-001	NCE	2028-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217188-002	NCE	2028-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-001	NCE	2028-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217188-002	NCE	2028-05-25	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217188-001	D-195	2028-01-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217188-001	NCE	2028-05-25	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paxlovid	NIRMATRELVIR AND RITONAVIR	Pfizer Laboratories Div Pfizer Inc	8a99d6d6-fd9e-45bb-b1bf-48c7f761232a	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217188 application number: NDA217188

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85066	SUPPL	2026-02-18
85065	SUPPL	2026-02-18
85037	SUPPL	2026-02-12
85036	SUPPL	2026-02-12
81251	SUPPL	2025-02-14
81239	SUPPL	2025-02-13
81101	SUPPL	2025-02-06
80968	SUPPL	2025-02-05
80258	SUPPL	2024-11-21
80253	SUPPL	2024-11-20
79619	SUPPL	2024-09-16
79585	SUPPL	2024-09-16
74614	ORIG	2023-06-23
74367	ORIG	2023-05-25
74366	ORIG	2023-05-25