Question 1

Is there a generic for Osimertinib mesylate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Osimertinib mesylate?

Accepted Answer

TAGRISSO (NDA 208065, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Osimertinib mesylate?

Accepted Answer

The Orange Book lists 5 patents against Osimertinib mesylate products, with the earliest listed expiry in 2032. 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 Osimertinib mesylate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Osimertinib mesylate. 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 Osimertinib mesylate are approved?

Accepted Answer

Osimertinib mesylate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
9732058	Jul 25, 2032	in 6 yr 2 mo	SubstanceProductU-1777
11524951	Jul 25, 2032	in 6 yr 2 mo	SubstanceProduct
8946235	Aug 08, 2032	in 6 yr 3 mo	SubstanceProductU-1777
10183020	Jan 02, 2035	in 8 yr 8 mo	ProductU-1777
12465608	Nov 26, 2042	in 16 yr 8 mo	U-3823

Osimertinib mesylate

Brand (NDA) products · tablet

Marketing exclusivity (6)

Listed patents (5)

Osimertinib mesylate — frequently asked questions

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