Question 1

Is there a generic for Treprostinil sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Treprostinil sodium?

Accepted Answer

YUTREPIA (NDA 213005, LIQUIDIA TECH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Treprostinil sodium?

Accepted Answer

The Orange Book lists 6 patents against Treprostinil sodium products, with the earliest listed expiry in 2037. 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 Treprostinil sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Treprostinil 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 Treprostinil sodium are approved?

Accepted Answer

Treprostinil sodium is approved in the following dosage form: powder.

Patent	Expires	In	Type
11712442	May 05, 2037	in 11 yr	U-4200
10898494	May 05, 2037	in 11 yr	U-4200
11660304	May 05, 2037	in 11 yr	U-4200
12390475	May 05, 2037	in 11 yr	Product
11744836	May 05, 2037	in 11 yr	Product
11744835	May 05, 2037	in 11 yr	Product

Treprostinil sodium

Brand (NDA) products · powder

Marketing exclusivity (4)

Listed patents (6)

Treprostinil sodium — frequently asked questions

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