Orange Book product · Brand (NDA)

CLOTIC

CLOTRIMAZOLE

Brand (NDA)NDA 217628RX CARWIN PHARM ASSOC

Sep 26, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 26, 2025
9 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Sep 26, 2028
in 2 yr 4 mo
Exclusivity ends · ODE-549
Orphan-drug exclusivity (7 years)
Sep 26, 2032
in 6 yr 4 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Sep 26, 2033
in 7 yr 5 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Sep 26, 2037
in 11 yr 5 mo
Patent 12246006 expires
Listed drug product patent expiration.
May 26, 2042
in 16 yr 2 mo

Active ingredient

CLOTRIMAZOLE

Strength

Dosage form

SOLUTION/DROPS

Route

OTIC

TE code

Not listed

Application

NDA 217628

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

NPNew product exclusivity (3 years)
Sep 26, 2028
in 2 yr 4 mo
ODE-549Orphan-drug exclusivity (7 years)
Sep 26, 2032
in 6 yr 4 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 26, 2033
in 7 yr 5 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 26, 2037
in 11 yr 5 mo

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12246006	May 26, 2042	in 16 yr 2 mo	ProductU-4276