Assyro AI

FDA Orange Book · active-ingredient family

Phentolamine mesylate

Phentolamine mesylate is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RYZUMVI · NDA 217064

3

Brand (NDA)

2

Generics (ANDA)

11

Listed patents

1

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
RYZUMVIRLDFAMYGEN LIFE SCINDA 217064—Sep 25, 2023
ORAVERSERLDSEPTODONT HOLDINGNDA 022159—May 09, 2008
REGITINERLDNOVARTISNDA 008278—Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
PHENTOLAMINE MESYLATEPRECISION DOSE INCANDA 207686APJul 14, 2017
PHENTOLAMINE MESYLATEHIKMAANDA 040235APMar 11, 1998

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Sep 25, 2026

    in 3 mo

Listed patents (11)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12350366Jan 31, 2034in 7 yr 9 mo
Product
11844858Jan 31, 2034in 7 yr 9 mo
Product
9795560Jan 31, 2034in 7 yr 9 mo
Product
11090261Jan 31, 2034in 7 yr 9 mo
Product
10278918Jan 31, 2034in 7 yr 9 mo
Product
10772829Jan 31, 2034in 7 yr 9 mo
Product
12201616Oct 25, 2039in 13 yr 7 mo
U-3804
12201615Oct 25, 2039in 13 yr 7 mo
U-3804
11400077Oct 25, 2039in 13 yr 7 mo
U-3804
12576067Oct 25, 2039in 13 yr 7 mo
U-3804
12576066Oct 25, 2039in 13 yr 7 mo
U-3804

Phentolamine mesylate — 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.

Book a Demo