FDA Orange Book · active-ingredient family
Nicardipine hydrochloride
Nicardipine hydrochloride is approved as 5 brand and 24 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NICARDIPINE HYDROCHLORIDE · NDA 022276
5
Brand (NDA)
24
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, capsule, extended release, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDERLD×3 | HIKMA INTL PHARMS | NDA 022276 | AP | Jul 24, 2008 | |
| CARDENE SRRLD×3 | CHIESI | NDA 020005 | — | Feb 21, 1992 | |
| CARDENERLD×5 | CHIESI | NDA 019734 | AP | Jan 30, 1992 | |
| CARDENERLD×2 | CHIESI | NDA 019488 | — | Dec 21, 1988 | |
| NICARDIPINE HYDROCHLORIDE | SUN PHARM | NDA 078405 | — | Nov 17, 2009 |
Generic (ANDA) products (24)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NICARDIPINE HYDROCHLORIDE | QILU PHARM HAINAN | ANDA 219608 | AP | Oct 28, 2025 | |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE×2 | CAPLIN | ANDA 220243 | AP | Oct 22, 2025 | |
| NICARDIPINE HYDROCHLORIDE | NANJING KING FRIEND | ANDA 216819 | AP | Aug 20, 2025 | |
| NICARDIPINE HYDROCHLORIDE×2 | NAVINTA LLC | ANDA 218638 | — | Jun 25, 2025 | |
| NICARDIPINE HYDROCHLORIDE | AMNEAL | ANDA 215406 | — | Oct 31, 2024 | |
| NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE×2 | CIPLA | ANDA 215592 | AP | Sep 24, 2024 | |
| NICARDIPINE HYDROCHLORIDE | CHENGDU SHUODE | ANDA 217548 | AP | Sep 06, 2024 | |
| NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE×2 | INFORLIFE | ANDA 203978 | AP | Apr 17, 2024 | |
| NICARDIPINE HYDROCHLORIDE×2 | AMNEAL | ANDA 218202 | AB | Apr 10, 2024 | |
| NICARDIPINE HYDROCHLORIDE×2 | SENORES PHARMS | ANDA 215377 | AB | Jul 17, 2023 | |
| NICARDIPINE HYDROCHLORIDE | MICRO LABS | ANDA 216420 | AP | Jul 07, 2023 | |
| NICARDIPINE HYDROCHLORIDE×2 | BIONPHARMA | ANDA 217555 | AB | May 03, 2023 | |
| NICARDIPINE HYDROCHLORIDE×2 | GLENMARK PHARMS LTD | ANDA 216357 | AB | Dec 16, 2022 | |
| NICARDIPINE HYDROCHLORIDE | EUGIA PHARMA | ANDA 211121 | AP | Apr 08, 2021 | |
| NICARDIPINE HYDROCHLORIDE | HIKMA | ANDA 078714 | — | Dec 28, 2009 | |
| NICARDIPINE HYDROCHLORIDE | AM REGENT | ANDA 090534 | AP | Nov 17, 2009 | |
| NICARDIPINE HYDROCHLORIDE | MANKIND PHARMA | ANDA 090671 | AP | Nov 17, 2009 | |
| NICARDIPINE HYDROCHLORIDE | NAVINTA LLC | ANDA 090125 | — | Nov 17, 2009 | |
| NICARDIPINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 090664 | AP | Nov 17, 2009 | |
| NICARDIPINE HYDROCHLORIDE×2 | EPIC PHARMA LLC | ANDA 074928 | AB | Mar 19, 1998 | |
| NICARDIPINE HYDROCHLORIDE×2 | ANI PHARMS | ANDA 074439 | — | Dec 10, 1996 | |
| NICARDIPINE HYDROCHLORIDE×2 | ANI PHARMS | ANDA 074540 | — | Oct 28, 1996 | |
| NICARDIPINE HYDROCHLORIDE×2 | ANI PHARMS | ANDA 074670 | AB | Oct 28, 1996 | |
| NICARDIPINE HYDROCHLORIDE×2 | PHARMOBEDIENT | ANDA 074642 | — | Jul 18, 1996 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7659291 | Apr 18, 2027 | in 10 mo | U-1029 |
| 11547758 | Apr 18, 2027 | in 10 mo | U-1029 |
| 8455524 | Apr 18, 2027 | in 10 mo | U-1029 |
| 10758616 | Apr 18, 2027 | in 10 mo | Product |
| 9364564 | Dec 26, 2027 | in 1 yr 7 mo | Product |
| 7612102 | Dec 26, 2027 | in 1 yr 7 mo | Product |
Nicardipine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
