FDA Orange Book · active-ingredient family
Mesna
Mesna is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MESNEX · NDA 020855
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MESNA | EUGIA PHARMA | ANDA 220518 | AP | Jan 27, 2026 | |
| MESNA | INGENUS PHARMS LLC | ANDA 218871 | AB | Jan 13, 2025 | |
| MESNA | GLAND | ANDA 206992 | AP | Dec 18, 2017 | |
| MESNA | RISING | ANDA 203364 | — | Jul 18, 2014 | |
| MESNA | MYLAN INSTITUTIONAL | ANDA 076488 | — | Mar 08, 2012 | |
| MESNA | SAGENT PHARMS INC | ANDA 090913 | AP | Apr 13, 2010 | |
| MESNA | HIKMA | ANDA 075739 | AP | Jan 09, 2004 | |
| MESNA | TEVA PHARMS USA | ANDA 075764 | — | Apr 27, 2001 | |
| MESNA | FRESENIUS KABI USA | ANDA 075811 | AP | Apr 26, 2001 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Mesna — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
