Question 1

Is there a generic for Ensifentrine?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ensifentrine?

Accepted Answer

OHTUVAYRE (NDA 217389, MSD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ensifentrine?

Accepted Answer

The Orange Book lists 5 patents against Ensifentrine products, with the earliest listed expiry in 2031. 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 Ensifentrine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Ensifentrine. 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 Ensifentrine are approved?

Accepted Answer

Ensifentrine is approved in the following dosage form: suspension.

Patent	Expires	In	Type
9062047	Aug 21, 2031	in 5 yr 3 mo	SubstanceU-3962
9956171	Sep 15, 2035	in 9 yr 5 mo	ProductU-3962
10945950	Sep 15, 2035	in 9 yr 5 mo	Product
12409180	Feb 20, 2043	in 16 yr 11 mo	Product
12251384	Jun 25, 2044	in 18 yr 3 mo	Product

Ensifentrine

Brand (NDA) products · suspension

Marketing exclusivity (1)

Listed patents (5)

Ensifentrine — frequently asked questions

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