Question 1

Is there a generic for Capivasertib?

Accepted Answer

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

Question 2

What is the reference-listed drug for Capivasertib?

Accepted Answer

TRUQAP (NDA 218197, 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 Capivasertib?

Accepted Answer

The Orange Book lists 7 patents against Capivasertib products, with the earliest listed expiry in 2028. 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 Capivasertib have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Capivasertib is approved in the following dosage form: tablet.

Patent	Expires	In	Type
11760760	Oct 10, 2028	in 2 yr 4 mo	U-3762
10654855	Oct 10, 2028	in 2 yr 4 mo	U-3762
12252495	Oct 10, 2028	in 2 yr 4 mo	U-3762
10059714	Oct 10, 2028	in 2 yr 4 mo	SubstanceProduct
8101623	Mar 10, 2030	in 3 yr 9 mo	SubstanceProductU-3762
10039766	Apr 16, 2033	in 6 yr 11 mo	U-3762
9487525	Apr 16, 2033	in 6 yr 11 mo	SubstanceProduct

Capivasertib

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (7)

Capivasertib — frequently asked questions

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