Question 1

Is there a generic for Bedaquiline fumarate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Bedaquiline fumarate?

Accepted Answer

SIRTURO (NDA 204384, JANSSEN THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Bedaquiline fumarate?

Accepted Answer

The Orange Book lists 2 patents against Bedaquiline fumarate 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 Bedaquiline fumarate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Bedaquiline fumarate. 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 Bedaquiline fumarate are approved?

Accepted Answer

Bedaquiline fumarate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7498343	Dec 01, 2026	in 6 mo	SubstanceProductU-1321
8546428	Mar 19, 2029	in 2 yr 9 mo	SubstanceProductU-1321

Bedaquiline fumarate

Brand (NDA) products · tablet

Marketing exclusivity (6)

Listed patents (2)

Bedaquiline fumarate — frequently asked questions

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