Question 1

Is there a generic for Donidalorsen sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Donidalorsen sodium?

Accepted Answer

DAWNZERA (AUTOINJECTOR) (NDA 219407, IONIS PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Donidalorsen sodium?

Accepted Answer

The Orange Book lists 5 patents against Donidalorsen sodium products, with the earliest listed expiry in 2032. 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.

Question 4

Does Donidalorsen sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Donidalorsen 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.

Question 5

What dosage forms of Donidalorsen sodium are approved?

Accepted Answer

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

Patent	Expires	In	Type
9315811	Oct 21, 2032	in 6 yr 5 mo	U-3010
9127276	May 01, 2034	in 8 yr	Substance
9181549	May 01, 2034	in 8 yr	Substance
9670492	Aug 28, 2034	in 8 yr 4 mo	Substance
10294477	May 01, 2035	in 9 yr	SubstanceProductU-3010

Donidalorsen sodium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (5)

Donidalorsen sodium — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.