Drybench Patent.

PATISIRAN SODIUM, NDA 210922

The patents and exclusivities FDA's Orange Book lists for NDA 210922 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026
Last checked: 30 October 2026
Data-branch commit: dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app PATISIRAN SODIUM in the molecule app

Listed protection

Listed dates run from 13 Jan 2026 to 27 Aug 2035, each by its own rule; no one date stands for this product.

Earliest listed date: 13 Jan 2026M-270 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 927
Latest listed date: 27 Aug 2035US 11,079,379, substance and product and use patentRule R1 · Product 001
Source lines
patent.txt line 12,395
Latest substance patent: 27 Aug 2035US 11,079,379, substance and product and use patentRule R1 · Product 001
Source lines
patent.txt line 12,395
Latest listed patent: 27 Aug 2035US 11,079,379, substance and product and use patentRule R1 · Product 001
Source lines
patent.txt line 12,395
Latest exclusivity: 13 Jan 2026M-270 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 927

Listed dates of other NDAs in the same years:2026 2027 2029 2030 2032 2035

9 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 210922, as listed. The sections below name products by these numbers.

Product 001 · ONPATTRO
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)
Approval date as listed
10 Aug 2018
Type as listed
RX
Applicant as listed
ALNYLAM PHARMACEUTICALS INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

13 entries from 13 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 8,642,076, product patent
patent.txt line 12,401
Expiry as listed
3 Oct 2027
Rule
R1
Flags
product
Product numbers
001
US 11,141,378, product patent
patent.txt line 12,396
Expiry as listed
15 Apr 2029
Rule
R1
Flags
product
Product numbers
001
US 8,058,069, product patent
patent.txt line 12,397
Expiry as listed
15 Apr 2029
Rule
R1
Flags
product
Product numbers
001
US 8,492,359, product patent
patent.txt line 12,400
Expiry as listed
15 Apr 2029
Rule
R1
Flags
product
Product numbers
001
US 8,822,668, product and use patent
patent.txt line 12,404
Expiry as listed
15 Apr 2029
Rule
R1
Flags
product · use code U-2378
Product numbers
001
US 9,364,435, product and use patent
patent.txt line 12,406
Expiry as listed
15 Apr 2029
Rule
R1
Flags
product · use code U-2378
Product numbers
001
US 10,240,152, substance and product and use patent
patent.txt line 12,394
Expiry as listed
20 Oct 2029
Rule
R1
Flags
substance · product · use code U-2378
Product numbers
001
US 8,741,866, use patent
patent.txt line 12,402
Expiry as listed
20 Oct 2029
Rule
R1
Flags
use code U-2378
Product numbers
001
US 9,234,196, product and use patent
patent.txt line 12,405
Expiry as listed
20 Oct 2029
Rule
R1
Flags
product · use code U-2378
Product numbers
001
US 8,802,644, product and use patent
patent.txt line 12,403
Expiry as listed
21 Oct 2030
Rule
R1
Flags
product · use code U-2378
Product numbers
001
US 8,158,601, product and use patent
patent.txt line 12,398
Expiry as listed
10 Nov 2030
Rule
R1
Flags
product · use code U-2378
Product numbers
001
US 8,168,775, substance and product and use patent
patent.txt line 12,399
Expiry as listed
10 Aug 2032
Rule
R1
Flags
substance · product · use code U-2378
Product numbers
001
US 11,079,379, substance and product and use patent
patent.txt line 12,395
Expiry as listed
27 Aug 2035
Rule
R1
Flags
substance · product · use code U-2378
Product numbers
001

Listed exclusivities

Each exclusivity FDA lists for NDA 210922, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

M-270 exclusivity
exclusivity.txt line 927
Date
13 Jan 2026
Rule
R3
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001

Paragraph IV list rows giving NDA 210922

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 210922, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 210922 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

Notes from the trace

R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week