Application 205718

Type: NDA
Sponsor: HELSINN HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AKYNZEO	NETUPITANT; PALONOSETRON HYDROCHLORIDE	CAPSULE;ORAL	300MG;EQ 0.5MG BASE	Yes	Yes

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
N205718-001	AKYNZEO	NETUPITANT; PALONOSETRON HYDROCHLORIDE	300MG;EQ 0.5MG BASE	CAPSULE / ORAL		RLD, RS	2014-10-10

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22
N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07
N205718-001	8623826	2030-11-18	U-2293		2014-11-06
N205718-001	8951969	2030-11-18		Drug product	2015-03-06
N205718-001	9186357	2030-11-18	U-2293		2015-12-02
N205718-001	9943515	2030-11-18	U-2293		2018-05-16
N205718-001	10828297	2030-12-17	U-2293		2020-12-04
N205718-001	9271975	2031-09-09	U-2293		2016-07-14
N205718-001	10233154	2035-09-25		Drug substance	2019-03-28
N205718-001	10676440	2035-09-25		Drug substance, Drug product	2020-07-08
N205718-001	10961195	2035-09-25		Drug substance, Drug product	2021-04-15
N205718-001	9951016	2035-09-25		Drug substance, Drug product	2018-05-16

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205718-001	AKYNZEO	300MG;EQ 0.5MG BASE	CAPSULE / ORAL	RLD, RS	2014-10-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 475 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	N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	8623826	2030-11-18	U-2293		2014-11-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	8951969	2030-11-18		Drug product	2015-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	9186357	2030-11-18	U-2293		2015-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	9943515	2030-11-18	U-2293		2018-05-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	10828297	2030-12-17	U-2293		2020-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	9271975	2031-09-09	U-2293		2016-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	10233154	2035-09-25		Drug substance	2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	10676440	2035-09-25		Drug substance, Drug product	2020-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	10961195	2035-09-25		Drug substance, Drug product	2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205718-001	9951016	2035-09-25		Drug substance, Drug product	2018-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	8623826	2030-11-18	U-2293		2014-11-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	8951969	2030-11-18		Drug product	2015-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	9186357	2030-11-18	U-2293		2015-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	9943515	2030-11-18	U-2293		2018-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	10828297	2030-12-17	U-2293		2020-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	9271975	2031-09-09	U-2293		2016-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	10233154	2035-09-25		Drug substance	2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	10676440	2035-09-25		Drug substance, Drug product	2020-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	10961195	2035-09-25		Drug substance, Drug product	2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205718-001	9951016	2035-09-25		Drug substance, Drug product	2018-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	8623826	2030-11-18	U-2293		2014-11-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	8951969	2030-11-18		Drug product	2015-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	9186357	2030-11-18	U-2293		2015-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	9943515	2030-11-18	U-2293		2018-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	10828297	2030-12-17	U-2293		2020-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	9271975	2031-09-09	U-2293		2016-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	10233154	2035-09-25		Drug substance	2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	10676440	2035-09-25		Drug substance, Drug product	2020-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	10961195	2035-09-25		Drug substance, Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205718-001	9951016	2035-09-25		Drug substance, Drug product	2018-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205718-001	11559523	2030-11-18	U-3522	Drug product	2023-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205718-001	12042494	2030-11-18	U-3522	Drug product	2024-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205718-001	8623826	2030-11-18	U-2293		2014-11-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205718-001	8951969	2030-11-18		Drug product	2015-03-06	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205718-001	NCE	2019-10-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N205718-001	NCE	2019-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205718-001	NCE	2019-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205718-001	NCE	2019-10-10	`ea99ee380514…`

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
AKYNZEO	NETUPITANT AND PALONOSETRON	Helsinn Therapeutics (U.S.), Inc.	8e47618e-af46-4d82-94e8-1507c042252d	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205718 application number: NDA205718 ndc (product): 69639-101

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current
69639-101	AKYNZEO	Netupitant and Palonosetron	Helsinn Therapeutics (U.S.), Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67691	SUPPL	2021-06-03
67686	SUPPL	2021-06-03
19676	SUPPL	2015-05-06
19677	SUPPL	2015-05-04
32710	SUPPL	2015-04-29
24502	ORIG	2014-11-07
23000	ORIG	2014-11-07
19675	ORIG	2014-10-14
32709	ORIG	2014-10-10