Orange Book product · Brand (NDA)

CYSVIEW KIT

HEXAMINOLEVULINATE HYDROCHLORIDE

Brand (NDA)NDA 022555RX PHOTOCURE ASA

May 28, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 28, 2010
16 yr 4 mo ago
Today
Patent 10556010 expires
Listed method-of-use patent (U-2250) expiration.
Dec 19, 2036
in 10 yr 8 mo
Patent 11311620 expires
Listed method-of-use patent (U-2250) expiration.
Dec 19, 2036
in 10 yr 8 mo
Patent 11235168 expires
Listed method-of-use patent (U-2250) expiration.
Jan 04, 2038
in 11 yr 9 mo

Active ingredient

HEXAMINOLEVULINATE HYDROCHLORIDE

Strength

100MG/VIAL

Dosage form

FOR SOLUTION

Route

INTRAVESICAL

TE code

Not listed

Application

NDA 022555

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
10556010	Dec 19, 2036	in 10 yr 8 mo	U-2250
11311620	Dec 19, 2036	in 10 yr 8 mo	U-2250
11235168	Jan 04, 2038	in 11 yr 9 mo	U-2250