Application 213189

Type: NDA
Sponsor: ATHENEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KLISYRI	TIRBANIBULIN	OINTMENT;TOPICAL	1%	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N213189-001	KLISYRI	TIRBANIBULIN	1%	OINTMENT / TOPICAL		RLD, RS	2020-12-14

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213189-001	10323001	2027-12-28		Drug product	2021-01-12
N213189-001	7851470	2029-02-02	U-3015	Drug substance, Drug product	2021-01-12
N213189-001	7300931	2030-12-28		Drug substance, Drug product	2021-01-12
N213189-001	10617693	2038-03-12	U-3015		2021-01-12
N213189-001	11497750	2038-03-12	U-3015		2022-12-14
N213189-001	12667576	2038-03-12	U-4577		2026-07-22
N213189-001	10669236	2038-09-07		Drug substance, Drug product	2021-01-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213189-001	D-192	2027-06-07

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
2026-08-18 06:07:40	2026-07	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213189-001	KLISYRI	1%	OINTMENT / TOPICAL	RLD, RS	2020-12-14	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 272 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213189-001	10323001	2027-12-28		Drug product	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213189-001	7851470	2029-02-02	U-3015	Drug substance, Drug product	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213189-001	7300931	2030-12-28		Drug substance, Drug product	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213189-001	10617693	2038-03-12	U-3015		2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213189-001	11497750	2038-03-12	U-3015		2022-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213189-001	12667576	2038-03-12	U-4577		2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213189-001	10669236	2038-09-07		Drug substance, Drug product	2021-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213189-001	10323001	2027-12-28		Drug product	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213189-001	7851470	2029-02-02	U-3015	Drug substance, Drug product	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213189-001	7300931	2030-12-28		Drug substance, Drug product	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213189-001	10617693	2038-03-12	U-3015		2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213189-001	11497750	2038-03-12	U-3015		2022-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213189-001	10669236	2038-09-07		Drug substance, Drug product	2021-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	8236799	2025-12-28		Drug substance, Drug product	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	8980890	2025-12-28		Drug substance, Drug product	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	10323001	2027-12-28		Drug product	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	7851470	2029-02-02	U-3015	Drug substance, Drug product	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	7300931	2030-12-28		Drug substance, Drug product	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	10617693	2038-03-12	U-3015		2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	11497750	2038-03-12	U-3015		2022-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	10669236	2038-09-07		Drug substance, Drug product	2021-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213189-001	8236799	2025-12-28		Drug substance, Drug product	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	8980890	2025-12-28		Drug substance, Drug product	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	7300931	2026-02-06		Drug substance, Drug product	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	10323001	2027-12-28		Drug product	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	7851470	2029-02-02	U-3015	Drug substance, Drug product	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	10617693	2038-03-12	U-3015		2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	11497750	2038-03-12	U-3015		2022-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	10669236	2038-09-07		Drug substance, Drug product	2021-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	8236799	2025-12-28		Drug substance, Drug product	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	8980890	2025-12-28		Drug substance, Drug product	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	7300931	2026-02-06		Drug substance, Drug product	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	10323001	2027-12-28		Drug product	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	7851470	2029-02-02	U-3015	Drug substance, Drug product	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	10617693	2038-03-12	U-3015		2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	11497750	2038-03-12	U-3015		2022-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	10669236	2038-09-07		Drug substance, Drug product	2021-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213189-001	8236799	2025-12-28		Drug substance, Drug product	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213189-001	8980890	2025-12-28		Drug substance, Drug product	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213189-001	7300931	2026-02-06		Drug substance, Drug product	2021-01-12	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213189-001	D-192	2027-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213189-001	D-192	2027-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	NCE	2025-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213189-001	D-192	2027-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213189-001	NCE	2025-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213189-001	D-192	2027-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	NCE	2025-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213189-001	D-192	2027-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213189-001	NCE	2025-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213189-001	D-192	2027-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213189-001	NCE	2025-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213189-001	D-192	2027-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213189-001	NCE	2025-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213189-001	D-192	2027-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213189-001	NCE	2025-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213189-001	D-192	2027-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213189-001	NCE	2025-12-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213189-001	D-192	2027-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213189-001	NCE	2025-12-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213189-001	D-192	2027-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213189-001	NCE	2025-12-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213189-001	D-192	2027-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213189-001	NCE	2025-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213189-001	NCE	2025-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213189-001	NCE	2025-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213189-001	NCE	2025-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213189-001	NCE	2025-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213189-001	NCE	2025-12-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213189-001	NCE	2025-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213189-001	NCE	2025-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213189-001	NCE	2025-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213189-001	NCE	2025-12-14	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213189-001	NCE	2025-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213189-001	NCE	2025-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213189-001	NCE	2025-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213189-001	NCE	2025-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213189-001	NCE	2025-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213189-001	NCE	2025-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213189-001	NCE	2025-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213189-001	NCE	2025-12-14	`053a50430f4f…`

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
Klisyri	TIRBANIBULIN	Almirall, LLC	589c8de8-b773-4d47-b60c-48471806cccc	2024-11-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213189 application number: NDA213189 ndc (product): 16110-391

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16110-391	Klisyri	tirbanibulin	Almirall, LLC	NDA	Current
16110-391	Klisyri	tirbanibulin	Almirall, LLC	NDA	Current
16110-391	Klisyri	tirbanibulin	Almirall, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78759	SUPPL	2024-07-02
78758	SUPPL	2024-07-02
78757	SUPPL	2024-07-02
78775	SUPPL	2024-06-12
78774	SUPPL	2024-06-12
78773	SUPPL	2024-06-12
65761	ORIG	2020-12-28
65598	ORIG	2020-12-15
65590	ORIG	2020-12-15