Question 1

Is there a generic for Oteseconazole?

Accepted Answer

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

Question 2

What is the reference-listed drug for Oteseconazole?

Accepted Answer

VIVJOA (NDA 215888, MYCOVIA PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Oteseconazole?

Accepted Answer

The Orange Book lists 5 patents against Oteseconazole products, with the earliest listed expiry in 2031. 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 Oteseconazole have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Oteseconazole is approved in the following dosage form: capsule.

Patent	Expires	In	Type
8754227	Apr 22, 2031	in 4 yr 11 mo	U-3366
8236962	Apr 22, 2031	in 4 yr 11 mo	SubstanceProduct
11247981	May 09, 2033	in 7 yr	U-3366
9840492	Mar 17, 2036	in 9 yr 11 mo	SubstanceProduct
10414751	Mar 17, 2036	in 9 yr 11 mo	SubstanceProduct

Oteseconazole

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (5)

Oteseconazole — frequently asked questions

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