Assyro AI

FDA Orange Book · active-ingredient family

Hexaminolevulinate hydrochloride

Hexaminolevulinate hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:CYSVIEW KIT · NDA 022555

1

Brand (NDA)

0

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · for solution

ProductApplicantApplicationTEApproved
CYSVIEW KITRLDPHOTOCURE ASANDA 022555May 28, 2010

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10556010Dec 19, 2036in 10 yr 8 mo
U-2250
11311620Dec 19, 2036in 10 yr 8 mo
U-2250
11235168Jan 04, 2038in 11 yr 9 mo
U-2250

Hexaminolevulinate hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.