FDA Orange Book · active-ingredient family
Nimodipine
Nimodipine is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NYMALIZE · NDA 203340
2
Brand (NDA)
7
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NYMALIZERLD×2 | AZURITY | NDA 203340 | — | May 10, 2013 | |
| NIMOTOPRLD | BAYER PHARMS | NDA 018869 | — | Dec 28, 1988 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIMODIPINE | ALKEM LABS LTD | ANDA 213409 | AB | Jan 22, 2025 | |
| NIMODIPINE | ANNORA PHARMA | ANDA 216937 | — | Jul 09, 2024 | |
| NIMODIPINE | SOFGEN PHARMS | ANDA 201832 | — | Jul 24, 2015 | |
| NIMODIPINE | THEPHARMANETWORK LLC | ANDA 090103 | AB | Apr 07, 2014 | |
| NIMODIPINE | BIONPHARMA | ANDA 076740 | AB | Jan 17, 2008 | |
| NIMODIPINE | HERITAGE | ANDA 077811 | AB | May 02, 2007 | |
| NIMODIPINE | SUN PHARM INDS INC | ANDA 077067 | — | Apr 17, 2007 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11413277 | Apr 16, 2038 | in 12 yr | ProductU-2804 |
| 12186308 | Apr 16, 2038 | in 12 yr | ProductU-2804 |
| 10342787 | Apr 16, 2038 | in 12 yr | ProductU-2804 |
| 10576070 | Apr 16, 2038 | in 12 yr | ProductU-2804 |
| 11207306 | Apr 16, 2038 | in 12 yr | U-2804 |
| 11806338 | Apr 16, 2038 | in 12 yr | Product |
Nimodipine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
