Question 1

Is there a generic for Birch triterpenes?

Accepted Answer

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

Question 2

What is the reference-listed drug for Birch triterpenes?

Accepted Answer

FILSUVEZ (NDA 215064, CHIESI) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Birch triterpenes?

Accepted Answer

The Orange Book lists 6 patents against Birch triterpenes products, with the earliest listed expiry in 2026. 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 Birch triterpenes have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Birch triterpenes. 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 Birch triterpenes are approved?

Accepted Answer

Birch triterpenes is approved in the following dosage form: gel.

Patent	Expires	In	Type
8828444	Jun 21, 2026	in 2 d	Product
9827214	Nov 24, 2030	in 4 yr 6 mo	U-3811
9352041	Nov 24, 2030	in 4 yr 6 mo	U-3811
11266660	Jan 04, 2039	in 12 yr 9 mo	U-3811
12268695	Jan 04, 2039	in 12 yr 9 mo	U-3811
11083733	Jan 04, 2039	in 12 yr 9 mo	Product

Birch triterpenes

Brand (NDA) products · gel

Marketing exclusivity (2)

Listed patents (6)

Birch triterpenes — frequently asked questions

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