Application 210922

Type: NDA
Sponsor: ALNYLAM PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONPATTRO	PATISIRAN SODIUM	SOLUTION;INTRAVENOUS	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N210922-001	ONPATTRO	PATISIRAN SODIUM	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2018-08-10

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210922-001	8642076	2027-10-03		Drug product	2018-09-06
N210922-001	11141378	2029-04-15		Drug product	2021-11-09
N210922-001	8058069	2029-04-15		Drug product	2018-09-06
N210922-001	8492359	2029-04-15		Drug product	2018-09-06
N210922-001	8822668	2029-04-15	U-2378	Drug product	2018-09-06
N210922-001	9364435	2029-04-15	U-2378	Drug product	2018-09-06
N210922-001	10240152	2029-10-20	U-2378	Drug substance, Drug product	2021-09-03
N210922-001	8741866	2029-10-20	U-2378		2018-09-06
N210922-001	9234196	2029-10-20	U-2378	Drug product	2018-09-06
N210922-001	8802644	2030-10-21	U-2378	Drug product	2018-09-06
N210922-001	8158601	2030-11-10	U-2378	Drug product	2018-09-06
N210922-001	8168775	2032-08-10	U-2378	Drug substance, Drug product	2018-09-06
N210922-001	11079379	2035-08-27	U-2378	Drug substance, Drug product	2021-09-03

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210922-001	M-270	2026-01-13

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N210922-001	ONPATTRO	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-08-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210922-001	ONPATTRO	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-08-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210922-001	ONPATTRO	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-08-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210922-001	ONPATTRO	EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2018-08-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 707 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210922-001	8642076	2027-10-03		Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	11141378	2029-04-15		Drug product	2021-11-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8058069	2029-04-15		Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8492359	2029-04-15		Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8822668	2029-04-15	U-2378	Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	9364435	2029-04-15	U-2378	Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	10240152	2029-10-20	U-2378	Drug substance, Drug product	2021-09-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8741866	2029-10-20	U-2378		2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	9234196	2029-10-20	U-2378	Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8802644	2030-10-21	U-2378	Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8158601	2030-11-10	U-2378	Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	8168775	2032-08-10	U-2378	Drug substance, Drug product	2018-09-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210922-001	11079379	2035-08-27	U-2378	Drug substance, Drug product	2021-09-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210922-001	8642076	2027-10-03		Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	11141378	2029-04-15		Drug product	2021-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8058069	2029-04-15		Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8492359	2029-04-15		Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8822668	2029-04-15	U-2378	Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	9364435	2029-04-15	U-2378	Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	10240152	2029-10-20	U-2378	Drug substance, Drug product	2021-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8741866	2029-10-20	U-2378		2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	9234196	2029-10-20	U-2378	Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8802644	2030-10-21	U-2378	Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8158601	2030-11-10	U-2378	Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	8168775	2032-08-10	U-2378	Drug substance, Drug product	2018-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210922-001	11079379	2035-08-27	U-2378	Drug substance, Drug product	2021-09-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210922-001	8642076	2027-10-03		Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	11141378	2029-04-15		Drug product	2021-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8058069	2029-04-15		Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8492359	2029-04-15		Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8822668	2029-04-15	U-2378	Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	9364435	2029-04-15	U-2378	Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	10240152	2029-10-20	U-2378	Drug substance, Drug product	2021-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8741866	2029-10-20	U-2378		2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	9234196	2029-10-20	U-2378	Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8802644	2030-10-21	U-2378	Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8158601	2030-11-10	U-2378	Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	8168775	2032-08-10	U-2378	Drug substance, Drug product	2018-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210922-001	11079379	2035-08-27	U-2378	Drug substance, Drug product	2021-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210922-001	8642076	2027-10-03		Drug product	2018-09-06	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N210922-001	M-270	2026-01-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210922-001	M-270	2026-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210922-001	M-270	2026-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210922-001	M-270	2026-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210922-001	ODE-197	2025-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210922-001	M-270	2026-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210922-001	ODE-197	2025-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210922-001	M-270	2026-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210922-001	ODE-197	2025-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210922-001	M-270	2026-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210922-001	ODE-197	2025-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210922-001	M-270	2026-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210922-001	ODE-197	2025-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210922-001	M-270	2026-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210922-001	ODE-197	2025-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210922-001	M-270	2026-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210922-001	ODE-197	2025-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210922-001	M-270	2026-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210922-001	ODE-197	2025-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210922-001	M-270	2026-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210922-001	ODE-197	2025-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210922-001	M-270	2026-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210922-001	ODE-197	2025-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210922-001	M-270	2026-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210922-001	ODE-197	2025-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210922-001	ODE-197	2025-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210922-001	ODE-197	2025-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210922-001	NCE	2023-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210922-001	ODE-197	2025-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210922-001	NCE	2023-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210922-001	ODE-197	2025-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210922-001	NCE	2023-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210922-001	ODE-197	2025-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210922-001	NCE	2023-08-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210922-001	ODE-197	2025-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210922-001	NCE	2023-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210922-001	ODE-197	2025-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210922-001	NCE	2023-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210922-001	ODE-197	2025-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210922-001	NCE	2023-08-10	`87673890dc5c…`

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
Onpattro	PATISIRAN	Alnylam Pharmaceuticals, Inc.	e87ec36f-b4b4-49d4-aea4-d4ffb09b0970	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210922 application number: NDA210922 ndc (product): 71336-1000

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current
71336-1000	Onpattro	patisiran	Alnylam Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73195	SUPPL	2023-01-17
73185	SUPPL	2023-01-17
72267	SUPPL	2022-10-07
72239	SUPPL	2022-10-04
67474	SUPPL	2021-05-12
67445	SUPPL	2021-05-10
62610	SUPPL	2020-04-20
62599	SUPPL	2020-04-20
60029	SUPPL	2019-09-18
60021	SUPPL	2019-09-17
58662	SUPPL	2019-05-13
58602	SUPPL	2019-05-07
55395	ORIG	2018-09-07
55169	ORIG	2018-08-13
55153	ORIG	2018-08-10