FDA Orange Book · active-ingredient family
Mercaptopurine
Mercaptopurine is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PURIXAN · NDA 205919
2
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PURIXANRLD | NOVA LABS LTD | NDA 205919 | AB | Apr 28, 2014 | |
| PURINETHOLRLD | STASON PHARMS | NDA 009053 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MERCAPTOPURINE | HIKMA | ANDA 216418 | AB | Feb 26, 2025 | |
| MERCAPTOPURINE | MYLAN | ANDA 040594 | AB | Jul 01, 2005 | |
| MERCAPTOPURINE | HIKMA | ANDA 040528 | AB | Feb 13, 2004 | |
| MERCAPTOPURINE | DR REDDYS LABS SA | ANDA 040461 | AB | Feb 11, 2004 |
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.
Mercaptopurine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
