Is there a generic for Patisiran sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Patisiran sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Patisiran sodium?

ONPATTRO (NDA 210922, ALNYLAM PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Patisiran sodium?

The Orange Book lists 13 patents against Patisiran sodium products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Patisiran sodium have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Patisiran sodium. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Patisiran sodium are approved?

Patisiran sodium is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Patisiran sodium

Patisiran sodium: 1 brand, 0 generics; first approved Aug 10, 2018; on patent until Oct 03, 2027.

On patent1 exclusivity period

Generic status & protection

Protected until Oct 03, 2027 (earliest listed patent expiry).

Earliest patent expiry Oct 03, 2027Latest exclusivity ends Jan 13, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 03, 2027

in 1 yr 3 mo

Originator applications

Brand (NDA) products

ONPATTRORLDRS

ALNYLAM PHARMS INCNDA 2109222018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/5ML (EQ 2MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (1)

M-270New use / labeling-change exclusivity (3 years)
Jan 13, 2026
6 mo ago

Orange Book patent file

Listed patents

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8642076	Oct 03, 2027	in 1 yr 3 mo	Product
8822668	Apr 15, 2029	in 2 yr 10 mo	ProductU-2378
9364435	Apr 15, 2029	in 2 yr 10 mo	ProductU-2378
11141378	Apr 15, 2029	in 2 yr 10 mo	Product
8492359	Apr 15, 2029	in 2 yr 10 mo	Product
8058069	Apr 15, 2029	in 2 yr 10 mo	Product
9234196	Oct 20, 2029	in 3 yr 4 mo	ProductU-2378
8741866	Oct 20, 2029	in 3 yr 4 mo	U-2378
10240152	Oct 20, 2029	in 3 yr 4 mo	SubstanceProductU-2378
8802644	Oct 21, 2030	in 4 yr 4 mo	ProductU-2378
8158601	Nov 10, 2030	in 4 yr 5 mo	ProductU-2378
8168775	Aug 10, 2032	in 6 yr 2 mo	SubstanceProductU-2378
11079379	Aug 27, 2035	in 9 yr 3 mo	SubstanceProductU-2378

FDA approval span

Approval history

First approval

Aug 10, 2018

8 yr ago

Most recent approval

Aug 10, 2018

8 yr ago

All 1 application were approved in 2018.

Brand (NDA) 1100%

Generic (ANDA) 00%

Patisiran sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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