Drybench Patent.
OLEZARSEN SODIUM, NDA 218614
The patents and exclusivities FDA's Orange Book lists for NDA 218614 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.
Listed protection
Listed dates run from 24 Jun 2029 to 1 May 2034, each by its own rule; no one date stands for this product.
- Earliest listed date
- 24 Jun 2029I-992 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 2,172
- Latest listed date
- 1 May 2034US 9,181,549, substance patentRule R1 · Products 001, 002
Source lines
patent.txt lines 21,143, 21,149
- Latest substance patent
- 1 May 2034US 9,181,549, substance patentRule R1 · Products 001, 002
Source lines
patent.txt lines 21,143, 21,149
- Latest listed patent
- 1 May 2034US 9,181,549, substance patentRule R1 · Products 001, 002
Source lines
patent.txt lines 21,143, 21,149
- Latest exclusivity
- 19 Dec 2031ODE-515 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 2,173
Listed dates of other NDAs in the same years:2029203120322034
7 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 218614, as listed. The sections below name products by these numbers.
Product 001 · TRYNGOLZA (AUTOINJECTOR)
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
- Approval date as listed
- 19 Dec 2024
- Type as listed
- RX
- Applicant as listed
- IONIS PHARMACEUTICALS INC
Product 002 · TRYNGOLZA (AUTOINJECTOR)
- Dosage form; route
- SOLUTION;
SUBCUTANEOUS - Strength
- EQ 50MG BASE/0.8ML (EQ 50MG BASE/0.8ML)
- Approval date as listed
- 24 Jun 2026
- Type as listed
- RX
- Applicant as listed
- IONIS 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.
8 entries from 13 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 9,157,082, use patent
patent.txt line 21,140- Expiry as listed
- 27 Apr 2032
- Rule
- R1
- Flags
- use code U-4050
- Product numbers
- 001
US 9,157,082, use patent
patent.txt lines 21,141, 21,147- Expiry as listed
- 27 Apr 2032
- Rule
- R1
- Flags
- use code U-4580
- Product numbers
- 001, 002
US 9,593,333, use patent
patent.txt line 21,144- Expiry as listed
- 14 Feb 2034
- Rule
- R1
- Flags
- use code U-4050
- Product numbers
- 001
US 12,509,684, use patent
patent.txt line 21,137- Expiry as listed
- 1 May 2034
- Rule
- R1
- Flags
- use code U-4050
- Product numbers
- 001
US 12,509,684, use patent
patent.txt lines 21,138, 21,145- Expiry as listed
- 1 May 2034
- Rule
- R1
- Flags
- use code U-4580
- Product numbers
- 001, 002
US 9,127,276, substance patent
patent.txt lines 21,139, 21,146- Expiry as listed
- 1 May 2034
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 9,163,239, substance patent
patent.txt lines 21,142, 21,148- Expiry as listed
- 1 May 2034
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 9,181,549, substance patent
patent.txt lines 21,143, 21,149- Expiry as listed
- 1 May 2034
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 218614, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-992 exclusivity
exclusivity.txt line 2,172- Date
- 24 Jun 2029
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
NS exclusivity
exclusivity.txt line 2,174- Date
- 24 Jun 2029
- Rule
- R3
- Definition
- New strength (to be checked against FDA's list)
- Product numbers
- 002
ODE-515 exclusivity
exclusivity.txt line 2,173- Date
- 19 Dec 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
Paragraph IV list rows giving NDA 218614
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 218614, 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 218614 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 exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week