Question 1

Is there a generic for Taletrectinib adipate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Taletrectinib adipate?

Accepted Answer

IBTROZI (NDA 219713, NUVATION) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Taletrectinib adipate?

Accepted Answer

The Orange Book lists 2 patents against Taletrectinib adipate products, with the earliest listed expiry in 2033. 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 Taletrectinib adipate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Taletrectinib adipate. 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 Taletrectinib adipate are approved?

Accepted Answer

Taletrectinib adipate is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9751887	Jun 03, 2033	in 7 yr 1 mo	SubstanceProductU-4207
9187489	Jun 03, 2033	in 7 yr 1 mo	SubstanceProductU-4207

Taletrectinib adipate

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (2)

Taletrectinib adipate — frequently asked questions

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