FDA Orange Book · active-ingredient family
Amlodipine benzoate
Amlodipine benzoate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KATERZIA · NDA 211340
1
Brand (NDA)
1
Generics (ANDA)
13
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KATERZIARLD | AZURITY | NDA 211340 | — | Jul 08, 2019 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMLODIPINE BENZOATE | AMNEAL | ANDA 215035 | — | Jun 13, 2023 |
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10959991 | Oct 06, 2037 | in 11 yr 6 mo | U-39 |
| 10894039 | Oct 06, 2037 | in 11 yr 6 mo | U-3 |
| 11471409 | Oct 06, 2037 | in 11 yr 6 mo | U-3447 |
| 12336984 | Oct 06, 2037 | in 11 yr 6 mo | U-3447 |
| 11918685 | Oct 06, 2037 | in 11 yr 6 mo | U-3447 |
| 11701326 | Oct 06, 2037 | in 11 yr 6 mo | Product |
| 11484498 | Oct 06, 2037 | in 11 yr 6 mo | Product |
| 10952998 | Oct 06, 2037 | in 11 yr 6 mo | Product |
| 12383498 | Oct 06, 2037 | in 11 yr 6 mo | Product |
| 11364230 | Oct 06, 2037 | in 11 yr 6 mo | Product |
| 12053461 | Oct 06, 2037 | in 11 yr 6 mo | Product |
| 10695329 | Oct 16, 2037 | in 11 yr 6 mo | Product |
| 10799453 | Apr 11, 2039 | in 13 yr | Product |
Amlodipine benzoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
