Application 208627

Type: NDA
Sponsor: SIGA TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TPOXX	TECOVIRIMAT	CAPSULE;ORAL	200MG	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
N208627-001	TPOXX	TECOVIRIMAT	200MG	CAPSULE / ORAL		RLD, RS	2018-07-13

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208627-001	8039504	2027-07-23		Drug product	2018-08-09
N208627-001	12433868	2031-03-23		Drug product	2025-10-17
N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09
N208627-001	7737168	2031-09-04	U-2346		2018-08-09
N208627-001	11890270	2032-08-08	U-2346		2024-02-27

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.

Product history page 1 of 2 · 41 observed 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	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208627-001	TPOXX	200MG	CAPSULE / ORAL	RLD, RS	2018-07-13	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 223 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	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208627-001	12433868	2031-03-23		Drug product	2025-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	12433868	2031-03-23		Drug product	2025-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	8124643	2024-06-18		Drug substance, Drug product	2018-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	8124643	2024-06-18		Drug substance, Drug product	2018-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	8124643	2024-06-18		Drug substance, Drug product	2018-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	7737168	2031-09-04	U-2346		2018-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	11890270	2032-08-08	U-2346		2024-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208627-001	8124643	2024-06-18		Drug substance, Drug product	2018-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208627-001	8039504	2027-07-23		Drug product	2018-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208627-001	9339466	2031-03-23		Drug substance, Drug product	2018-08-09	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208627-001	ODE-200	2025-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208627-001	ODE-200	2025-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208627-001	ODE-200	2025-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208627-001	ODE-200	2025-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208627-001	ODE-200	2025-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208627-001	ODE-200	2025-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208627-001	ODE-200	2025-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208627-001	ODE-200	2025-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208627-001	ODE-200	2025-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208627-001	ODE-200	2025-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208627-001	ODE-200	2025-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208627-001	ODE-200	2025-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208627-001	ODE-200	2025-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208627-001	NCE	2023-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208627-001	ODE-200	2025-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208627-001	NCE	2023-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208627-001	ODE-200	2025-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208627-001	NCE	2023-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208627-001	ODE-200	2025-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208627-001	NCE	2023-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208627-001	ODE-200	2025-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208627-001	NCE	2023-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208627-001	ODE-200	2025-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208627-001	NCE	2023-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208627-001	ODE-200	2025-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208627-001	NCE	2023-07-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208627-001	ODE-200	2025-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208627-001	NCE	2023-07-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208627-001	ODE-200	2025-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208627-001	NCE	2023-07-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208627-001	ODE-200	2025-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208627-001	NCE	2023-07-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208627-001	ODE-200	2025-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208627-001	NCE	2023-07-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208627-001	ODE-200	2025-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208627-001	NCE	2023-07-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208627-001	ODE-200	2025-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208627-001	NCE	2023-07-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208627-001	ODE-200	2025-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208627-001	ODE-200	2025-07-13	`6a51e52b5d6a…`

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
TPOXX	TECOVIRIMAT MONOHYDRATE	SIGA Technologies, Inc.	fce826ab-4d6a-4139-a2ee-a304a913a253	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208627 application number: NDA208627 ndc (product): 50072-200

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50072-200	TPOXX	tecovirimat monohydrate	SIGA Technologies, Inc.	NDA	Current
50072-200	TPOXX	tecovirimat monohydrate	SIGA Technologies, Inc.	NDA	Current
50072-200	TPOXX	tecovirimat monohydrate	SIGA Technologies, Inc.	NDA	Current
50072-200	TPOXX	tecovirimat monohydrate	SIGA Technologies, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81642	SUPPL	2025-03-19
78627	SUPPL	2024-07-02
78625	SUPPL	2024-06-04
71096	SUPPL	2022-05-19
71094	SUPPL	2022-05-19
69454	SUPPL	2021-12-02
69404	SUPPL	2021-11-24
55177	ORIG	2018-08-15
54885	ORIG	2018-07-13
54884	ORIG	2018-07-13