Home Applications 215515 Application 215515
Type NDA
Sponsor ALNYLAM PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMVUTTRA VUTRISIRAN INJECTABLE;SUBCUTANEOUS 25MG 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 N215515-001 AMVUTTRA VUTRISIRAN SODIUM EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13
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 N215515-001 10131907 2028-08-24 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 10806791 2028-12-04 Drug substance 2022-07-13 N215515-001 8828956 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 9370581 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 8106022 2029-12-12 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 10570391 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 9399775 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 10612024 2035-08-14 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 11401517 2035-08-14 U-3396 Drug substance, Drug product 2022-08-31 N215515-001 10208307 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 10683501 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 11286486 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 N215515-001 12049628 2036-07-28 U-3396 Drug substance, Drug product 2024-08-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215515-001 AMVUTTRA 25MG/0.5ML (25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215515-001 AMVUTTRA 25MG/0.5ML (25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215515-001 AMVUTTRA 25MG/0.5ML (25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215515-001 AMVUTTRA 25MG/0.5ML (25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215515-001 AMVUTTRA 25MG/0.5ML (25MG/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215515-001 AMVUTTRA EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2022-06-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 10 · 361 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 N215515-001 10131907 2028-08-24 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 10806791 2028-12-04 Drug substance 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 8828956 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 9370581 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 8106022 2029-12-12 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 10570391 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 9399775 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 10612024 2035-08-14 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 11401517 2035-08-14 U-3396 Drug substance, Drug product 2022-08-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 10208307 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 10683501 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 11286486 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215515-001 12049628 2036-07-28 U-3396 Drug substance, Drug product 2024-08-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215515-001 10131907 2028-08-24 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 10806791 2028-12-04 Drug substance 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 8828956 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 9370581 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 8106022 2029-12-12 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 10570391 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 9399775 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 10612024 2035-08-14 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 11401517 2035-08-14 U-3396 Drug substance, Drug product 2022-08-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 10208307 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 10683501 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 11286486 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215515-001 12049628 2036-07-28 U-3396 Drug substance, Drug product 2024-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215515-001 10131907 2028-08-24 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 10806791 2028-12-04 Drug substance 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 8828956 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 9370581 2028-12-04 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 8106022 2029-12-12 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 10570391 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 9399775 2032-11-16 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 10612024 2035-08-14 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 11401517 2035-08-14 U-3396 Drug substance, Drug product 2022-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 10208307 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 10683501 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 11286486 2036-07-28 U-3396 Drug substance, Drug product 2022-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215515-001 12049628 2036-07-28 U-3396 Drug substance, Drug product 2024-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215515-001 10131907 2028-08-24 U-3396 Drug substance, Drug product 2022-07-13 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 64 observed states.
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71336-1003 AMVUTTRA VUTRISIRAN Alnylam Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81732 SUPPL 2025-03-26 81679 SUPPL 2025-03-24 81574 SUPPL 2025-03-14 81548 SUPPL 2025-03-13 73550 SUPPL 2023-02-17 73545 SUPPL 2023-02-17 71538 ORIG 2022-07-12 71306 ORIG 2022-06-14 71292 ORIG 2022-06-14