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Norvasc generic
About Norvasc
Norvasc (amlodipine) — originally marketed by Pfizer Inc.. Class: Calcium channel blocker (dihydropyridine). First approved 1992-07-31.
Approved generic versions (27)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| AMLODIPINE BENZOATE | marketed | 2019-01-01 | ||
| amlodipine and olmesartan | InVasc Therapeutics, Inc. | marketed | ||
| Amlodipine placebos | Shenzhen Ausa Pharmed Co.,Ltd | marketed | ||
| Amlodipine 10 | Boehringer Ingelheim | marketed | ||
| amlodipine/hydrochlorothiazide | Shanghai Jiao Tong University School of Medicine | marketed | ||
| Amlodipine (Norvasc) | Bayer | marketed | ||
| Amlodipine+intensive antihypertensive therapy | Beijing Tiantan Hospital | marketed | ||
| Amlodipine + Perindopril | Centre for Chronic Disease Control, India | marketed | ||
| Amlodipine-folic acid placebos | Shenzhen Ausa Pharmed Co.,Ltd | marketed | ||
| Amlodipine Besylate / Benazepril Hydrochloride | Dr. Reddy's Laboratories Limited | marketed | ||
| Amlodipine/Losartan/Chlorthalidone | Hanmi Pharmaceutical Company Limited | marketed | ||
| Amlodipine + Indapamide | Centre for Chronic Disease Control, India | marketed | ||
| Amlodipine besylate combined Spironolactone | Third Military Medical University | marketed | ||
| Amlodipine besylate and folic acid | Shenzhen Ausa Pharmed Co.,Ltd | marketed | ||
| Amlodipine camsylate | Organon and Co | marketed | ||
| Amlodipine+standard antihypertensive therapy | Beijing Tiantan Hospital | marketed | ||
| Amlodipine plus Metformin | Third Military Medical University | marketed | ||
| Amlodipine + Simvastatin | University of Pavia | marketed | ||
| Amlodipine, Telmisartan, Amiloride Compound , Simvastatin | Chinese Academy of Medical Sciences, Fuwai Hospital | marketed | ||
| amlodipine, hydralazine, terazosin or hydrochlorothiazide | Tulane University School of Medicine | marketed | ||
| Amlodipine/Olmesartan | Radboud University Medical Center | marketed | ||
| Amlodipine+Benazepril | TSH Biopharm Corporation Limited | marketed | ||
| Amlodipine 5 or 10 mg(oral) | GlaxoSmithKline | marketed | ||
| Amlodipine plus Hydrochlorothiazide | University of Abuja | marketed | ||
| Amlodipine/Atorvastatin | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | marketed | ||
| Amlodipine, Losartan | Hanmi Pharmaceutical Company Limited | marketed | ||
| Amlodipine 2.5 mg | Novartis | marketed |
Originator patent timeline
Active patents (0)
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.