Question 1

Is there a generic for Mobocertinib succinate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Mobocertinib succinate?

Accepted Answer

EXKIVITY (NDA 215310, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Mobocertinib succinate?

Accepted Answer

The Orange Book lists 2 patents against Mobocertinib succinate products, with the earliest listed expiry in 2035. 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 Mobocertinib succinate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Mobocertinib succinate. 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 Mobocertinib succinate are approved?

Accepted Answer

Mobocertinib succinate is approved in the following dosage form: capsule.

Patent	Expires	In	Type
10227342	May 13, 2035	in 9 yr	SubstanceProductU-3220
9796712	May 13, 2035	in 9 yr	SubstanceProduct

Mobocertinib succinate

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (2)

Mobocertinib succinate — frequently asked questions

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