FDA Orange Book · active-ingredient family
Amlodipine besylate
Amlodipine besylate is approved as 4 brand and 39 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SDAMLO · NDA 219531
4
Brand (NDA)
39
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, solution, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SDAMLORLD×3 | BRILLIAN PHARMA | NDA 219531 | — | Jul 24, 2025 | |
| NORLIQVARLD | CMP DEV LLC | NDA 214439 | — | Feb 24, 2022 | |
| AMLODIPINE BESYLATERLD×3 | SYNTHON PHARMS | NDA 022026 | — | Sep 27, 2007 | |
| NORVASCRLD×3 | VIATRIS | NDA 019787 | AB | Jul 31, 1992 |
Generic (ANDA) products (39)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE×3 | GRAVITI PHARMS | ANDA 201380 | AB | Feb 17, 2026 | |
| AMLODIPINE BESYLATE×3 | TEVA PHARMS INC | ANDA 219686 | AB | Jan 22, 2026 | |
| AMLODIPINE BESYLATE×3 | SUNSHINE | ANDA 206524 | — | May 04, 2018 | |
| AMLODIPINE BESYLATE×3 | PURACAP LABS BLU | ANDA 207821 | AB | Jul 11, 2016 | |
| AMLODIPINE BESYLATE×3 | CHINA RESOURCES | ANDA 090752 | AB | May 16, 2016 | |
| AMLODIPINE BESYLATE×3 | INVAGEN PHARMS | ANDA 206367 | AB | Dec 10, 2015 | |
| AMLODIPINE BESYLATE×3 | SOVEREIGN PHARMS | ANDA 204900 | — | Jul 23, 2015 | |
| AMLODIPINE BESYLATE×3 | UNICHEM | ANDA 203245 | AB | Oct 21, 2013 | |
| AMLODIPINE BESYLATE×3 | ACCORD HLTHCARE | ANDA 202553 | AB | Apr 29, 2013 | |
| AMLODIPINE BESYLATE×3 | HIKMA PHARMS | ANDA 077771 | — | Apr 12, 2011 | |
| AMLODIPINE BESYLATE×3 | OXFORD PHARMS | ANDA 078414 | AB | Apr 07, 2010 | |
| AMLODIPINE BESYLATE×3 | ORBION PHARMS | ANDA 078453 | AB | Jul 02, 2009 | |
| AMLODIPINE BESYLATE×3 | ALKEM | ANDA 078925 | AB | May 04, 2009 | |
| AMLODIPINE BESYLATE×3 | EPIC PHARMA LLC | ANDA 078552 | AB | Apr 08, 2009 | |
| AMLODIPINE BESYLATE×3 | TORRENT PHARMS | ANDA 078573 | — | Sep 22, 2008 | |
| AMLODIPINE BESYLATE×3 | PHARMOBEDIENT | ANDA 078224 | — | Feb 27, 2008 | |
| AMLODIPINE BESYLATE×3 | SUN PHARM INDUSTRIES | ANDA 078081 | — | Jan 31, 2008 | |
| AMLODIPINE BESYLATE×3 | AMNEAL PHARMS NY | ANDA 078477 | — | Jan 16, 2008 | |
| AMLODIPINE BESYLATE×3 | SUN PHARM INDS INC | ANDA 078231 | — | Nov 30, 2007 | |
| AMLODIPINE BESYLATE×3 | CIPLA | ANDA 077073 | AB | Sep 26, 2007 | |
| AMLODIPINE BESYLATE×3 | CHARTWELL RX | ANDA 076859 | — | Sep 10, 2007 | |
| AMLODIPINE BESYLATE×3 | WOCKHARDT | ANDA 078500 | — | Sep 06, 2007 | |
| AMLODIPINE BESYLATE×3 | PURACAP PHARM | ANDA 078131 | — | Sep 04, 2007 | |
| AMLODIPINE BESYLATE×3 | INVAGEN PHARMS | ANDA 077955 | AB | Aug 28, 2007 | |
| AMLODIPINE BESYLATE×3 | CHARTWELL RX | ANDA 076692 | AB | Jul 20, 2007 | |
| AMLODIPINE BESYLATE×3 | WATSON LABS | ANDA 077671 | — | Jul 19, 2007 | |
| AMLODIPINE BESYLATE×3 | AUROBINDO PHARMA | ANDA 078021 | AB | Jul 17, 2007 | |
| AMLODIPINE BESYLATE×3 | GEDEON RICHTER USA | ANDA 077333 | — | Jul 17, 2007 | |
| AMLODIPINE BESYLATE×3 | LUPIN | ANDA 078043 | AB | Jul 12, 2007 | |
| AMLODIPINE BESYLATE×3 | STRIDES PHARMA | ANDA 077516 | AB | Jul 11, 2007 | |
| AMLODIPINE BESYLATE×3 | GENPHARM | ANDA 077362 | — | Jul 09, 2007 | |
| AMLODIPINE BESYLATE×3 | HIKMA | ANDA 077262 | — | Jul 09, 2007 | |
| AMLODIPINE BESYLATE×3 | SCIEGEN PHARMS | ANDA 077759 | — | Jul 09, 2007 | |
| AMLODIPINE BESYLATE×3 | SUN PHARM INDS LTD | ANDA 077974 | — | Jul 09, 2007 | |
| AMLODIPINE BESYLATE×3 | ZYDUS PHARMS USA | ANDA 078226 | AB | Jul 09, 2007 | |
| AMLODIPINE BESYLATE×3 | TEVA | ANDA 076846 | AB | Jun 28, 2007 | |
| AMLODIPINE BESYLATE×3 | SYNTHON PHARMS | ANDA 077080 | — | Jun 27, 2007 | |
| AMLODIPINE BESYLATE×3 | COREPHARMA | ANDA 076719 | AB | May 23, 2007 | |
| AMLODIPINE BESYLATE×3 | MYLAN | ANDA 076418 | — | Oct 03, 2005 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12226528 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 11458095 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 12005141 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3311 |
| 12440441 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 11723866 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
| 11253474 | Feb 24, 2041 | in 14 yr 11 mo | ProductU-3309 |
Amlodipine besylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
