Orange Book product · Brand (NDA)

SORILUX

CALCIPOTRIENE

Brand (NDA)NDA 022563RX MAYNE PHARMA

Oct 06, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 06, 2010
15 yr 11 mo ago
Patent 8629128 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Patent 8629128 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Patent 8629128 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Today
Patent 8263580 expires
Listed drug product patent expiration.
May 07, 2028
in 1 yr 11 mo
Patent 8263580 expires
Listed drug product patent expiration.
May 07, 2028
in 1 yr 11 mo

Active ingredient

CALCIPOTRIENE

Strength

0.005%

Dosage form

AEROSOL, FOAM

Route

TOPICAL

TE code

Not listed

Application

NDA 022563

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.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8629128	May 26, 2026	24 d ago	ProductU-1280
8629128	May 26, 2026	24 d ago	ProductU-1767
8629128	May 26, 2026	24 d ago	ProductU-2662
8263580	May 07, 2028	in 1 yr 11 mo	ProductU-1280
8263580	May 07, 2028	in 1 yr 11 mo	ProductU-2662