Application 213716

Type: NDA
Sponsor: AURINIA PHARMACEUTICALS, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUPKYNIS	VOCLOSPORIN	CAPSULE; ORAL	7.9MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N213716-001	LUPKYNIS	VOCLOSPORIN	7.9MG	CAPSULE / ORAL		RLD, RS	2021-01-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213716-001	7332472	2027-10-17	U-3056	Drug substance, Drug product	2021-02-11
N213716-001	10286036	2037-12-07	U-3056		2021-02-11
N213716-001	11622991	2037-12-07	U-3056		2023-05-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213716-001	NCE	2026-01-22

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
2026-09-14 22:38:34	2026-08	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213716-001	LUPKYNIS	7.9MG	CAPSULE / ORAL	RLD, RS	2021-01-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213716-001	7332472	2027-10-17	U-3056	Drug substance, Drug product	2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213716-001	7332472	2027-10-17	U-3056	Drug substance, Drug product	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213716-001	7332472	2027-10-17	U-3056	Drug substance, Drug product	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213716-001	7332472	2026-01-17	U-3056	Drug substance, Drug product	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213716-001	7332472	2024-10-17	U-3056	Drug substance, Drug product	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213716-001	7332472	2025-10-17	U-3056	Drug substance, Drug product	2021-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213716-001	7332472	2024-10-17	U-3056	Drug substance, Drug product	2021-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213716-001	10286036	2037-12-07	U-3056		2021-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213716-001	11622991	2037-12-07	U-3056		2023-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213716-001	7332472	2024-10-17	U-3056	Drug substance, Drug product	2021-02-11	`301d65b070ca…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213716-001	NCE	2026-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213716-001	NCE	2026-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213716-001	NCE	2026-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213716-001	NCE	2026-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213716-001	NCE	2026-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213716-001	NCE	2026-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213716-001	NCE	2026-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213716-001	NCE	2026-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213716-001	NCE	2026-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213716-001	NCE	2026-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213716-001	NCE	2026-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213716-001	NCE	2026-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213716-001	NCE	2026-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213716-001	NCE	2026-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213716-001	NCE	2026-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213716-001	NCE	2026-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213716-001	NCE	2026-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213716-001	NCE	2026-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213716-001	NCE	2026-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213716-001	NCE	2026-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213716-001	NCE	2026-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213716-001	NCE	2026-01-22	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213716-001	NCE	2026-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213716-001	NCE	2026-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213716-001	NCE	2026-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213716-001	NCE	2026-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213716-001	NCE	2026-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213716-001	NCE	2026-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213716-001	NCE	2026-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213716-001	NCE	2026-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213716-001	NCE	2026-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213716-001	NCE	2026-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213716-001	NCE	2026-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213716-001	NCE	2026-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213716-001	NCE	2026-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213716-001	NCE	2026-01-22	`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
LUPKYNIS	VOCLOSPORIN	Aurinia Pharma U.S., Inc.	9f489295-1156-52c7-5fd0-5c4c52f9b813	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213716 application number: NDA213716 ndc (product): 75626-001

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
75626-001	LUPKYNIS	Voclosporin	Aurinia Pharma U.S., Inc.	NDA	Current
75626-001	LUPKYNIS	Voclosporin	Aurinia Pharma U.S., Inc.	NDA	Current
75626-001	LUPKYNIS	Voclosporin	Aurinia Pharma U.S., Inc.	NDA	Current
75626-001	LUPKYNIS	Voclosporin	Aurinia Pharma U.S., Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83701	SUPPL	2025-10-09
83696	SUPPL	2025-10-09
83695	SUPPL	2025-10-09
78322	SUPPL	2024-04-30
78308	SUPPL	2024-04-30
66342	ORIG	2021-02-24
66003	ORIG	2021-01-27
66002	ORIG	2021-01-27
65974	ORIG	2021-01-25