Question 1

Is there a generic for Drospirenone; estetrol?

Accepted Answer

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

Question 2

What is the reference-listed drug for Drospirenone; estetrol?

Accepted Answer

NEXTSTELLIS (NDA 214154, MAYNE PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Drospirenone; estetrol?

Accepted Answer

The Orange Book lists 7 patents against Drospirenone; estetrol 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 Drospirenone; estetrol have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Drospirenone; estetrol. 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 Drospirenone; estetrol are approved?

Accepted Answer

Drospirenone; estetrol is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7732430	Jan 15, 2028	in 1 yr 7 mo	ProductU-3152
12427114	Jun 17, 2036	in 10 yr 2 mo	ProductU-3152
11957694	Jun 17, 2036	in 10 yr 2 mo	Product
11793760	Jun 17, 2036	in 10 yr 2 mo	Product
11964055	Jun 17, 2036	in 10 yr 2 mo	Product
12233074	Feb 09, 2043	in 16 yr 11 mo	ProductU-3152
12458649	Oct 01, 2043	in 17 yr 6 mo	U-3152

Drospirenone; estetrol

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (7)

Drospirenone; estetrol — frequently asked questions

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