Amlodipine
As of the edition of 20 October 2026, Amlodipine is a small molecule: marketed, first approved in 1990 (FR); acts on CACNA1C, CACNA1D and CACNA1F and 1 more; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Norvasc
- First approved
- 21 August 1990 (FR)
- Approvals on record
- 99 in 7 regions
- Holder of the most recent approval
- Brillian Pharma; 21 holders in all
- Withdrawn from market
- 3 April 2017 (in some regions)
- Registered trials
- 380, 20 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Hormones; Urinary and reproductive; Pregnancy and women's health; Nervous system
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
ADHERA THERAPEUTICS INC holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
16 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product16 company-target rows are on route B because of Amlodipine.
See the 16 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 44 | 28 | 4 | 4 |
| Phase 1 | 91 | 80 | 2 | 1 |
| Phase 2 | 22 | 16 | 1 | 3 |
| Phase 3 | 119 | 106 | 4 | 4 |
| Phase 4 | 104 | 78 | 7 | 8 |
| All trials | 380 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Lead sponsor of trials | 1992 to now |
| Novartis | Applicant and Lead sponsor of trials | 2001 to now |
| Dr. Reddy's | Later holder and Lead sponsor of trials | 2002 to now |
| Boehringer Ingelheim | Later holder and Lead sponsor of trials | 2002 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 2004 to now |
| Synthon Pharmaceuticals | Later holder | 2007 to now |
| Takeda | Later holder and Lead sponsor of trials | 2007 to now |
| Dainippon Sumitomo Pharma | Later holder | 2012 to now |
| Servier | Applicant and Lead sponsor of trials | 2016 to now |
| Azurity Pharmaceuticals | Acquired holder | 2020 to now |
| Cmp | Later holder | 2022 to now |
| Brillian Pharma | Later holder and Lead sponsor of trials | 2022 to now |