FDA Orange Book · active-ingredient family
Topotecan hydrochloride
Topotecan hydrochloride is approved as 5 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TOPOTECAN · NDA 200199
5
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOPOTECANRLD×3 | SANDOZ INC | NDA 200199 | — | Feb 25, 2011 | |
| TOPOTECAN HYDROCHLORIDERLD | HOSPIRA INC | NDA 200582 | AP | Feb 02, 2011 | |
| HYCAMTINRLD×2 | SANDOZ | NDA 020981 | — | Oct 11, 2007 | |
| HYCAMTINRLD | SANDOZ | NDA 020671 | AP | May 28, 1996 | |
| TOPOTECAN HYDROCHLORIDE | MEITHEAL | NDA 022453 | — | Dec 20, 2012 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOPOTECAN HYDROCHLORIDE | NATCO PHARMA USA | ANDA 206074 | — | Nov 24, 2017 | |
| TOPOTECAN HYDROCHLORIDE×2 | ACCORD HLTHCARE | ANDA 204406 | — | Jul 06, 2017 | |
| TOPOTECAN HYDROCHLORIDE | INGENUS PHARMS LLC | ANDA 206962 | AP | Nov 30, 2016 | |
| TOPOTECAN HYDROCHLORIDE | SUN PHARM INDS LTD | ANDA 202203 | — | Aug 29, 2013 | |
| TOPOTECAN HYDROCHLORIDE | ACCORD HLTHCARE | ANDA 202351 | AP | Jun 26, 2013 | |
| TOPOTECAN HYDROCHLORIDE | RISING | ANDA 091542 | — | Aug 28, 2012 | |
| TOPOTECAN HYDROCHLORIDE | MEITHEAL | ANDA 201166 | — | Aug 08, 2012 | |
| TOPOTECAN HYDROCHLORIDE | DR REDDYS LABS LTD | ANDA 201191 | AP | Mar 09, 2011 | |
| TOPOTECAN HYDROCHLORIDE | SAGENT PHARMS | ANDA 091284 | AP | Jan 26, 2011 | |
| TOPOTECAN HYDROCHLORIDE | ACTAVIS TOTOWA | ANDA 090620 | AP | Dec 02, 2010 | |
| TOPOTECAN HYDROCHLORIDE | TEYRO LABS | ANDA 091199 | AP | Dec 01, 2010 | |
| TOPOTECAN HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 091089 | AP | Nov 29, 2010 | |
| TOPOTECAN HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 091376 | — | Nov 29, 2010 |
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.
Topotecan hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
