Question 1

Is there a generic for Etonogestrel?

Accepted Answer

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

Question 2

What is the reference-listed drug for Etonogestrel?

Accepted Answer

NEXPLANON (NDA 021529, ORGANON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Etonogestrel?

Accepted Answer

The Orange Book lists 4 patents against Etonogestrel products, with the earliest listed expiry in 2026. 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 Etonogestrel have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Etonogestrel. 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 Etonogestrel are approved?

Accepted Answer

Etonogestrel is approved in the following dosage form: implant.

Patent	Expires	In	Type
8888745	Aug 28, 2026	in 2 mo	Product
10821277	May 31, 2027	in 1 yr	Product
8722037	Sep 28, 2027	in 1 yr 4 mo	Product
9757552	Jul 28, 2030	in 4 yr 2 mo	ProductU-1

Etonogestrel

Brand (NDA) products · implant

Marketing exclusivity (1)

Listed patents (4)

Etonogestrel — frequently asked questions

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