Amlodipine Drug Intelligence — PatSnap Eureka
Amlodipine: Patent, Competitor & Indication Intelligence
Amlodipine is a long-acting dihydropyridine L-type calcium channel blocker originated by Pfizer, first approved in 1993 for hypertension and coronary artery disease. All core patents have expired, shifting commercial focus to novel salts, stereoisomers, and combination formulations.
Amlodipine: Overview of a Mature Cardiovascular Agent
Amlodipine is a small-molecule dihydropyridine calcium channel blocker originated by Pfizer Inc. First approved on October 1, 1993, it holds NDA/BLA approved status globally. The drug is now a mature generic with zero active patents in the PatSnap Eureka dataset, reflecting decades of market presence since its original composition-of-matter filing in 1988.
Amlodipine selectively blocks L-type voltage-gated calcium channels in vascular smooth muscle and cardiac myocytes. By preventing calcium ion influx during membrane depolarization, it reduces intracellular calcium, leading to peripheral vasodilation and coronary artery dilation. Its long plasma half-life of approximately 35–50 hours supports once-daily dosing.
Four indications are recorded in the PatSnap Eureka dataset. Hypertension and coronary artery disease are the primary approved indications. Fissure in Ano represents a research-stage niche application based on topical smooth muscle relaxation. Active organizations including Tavanta Therapeutics and the University of Surrey suggest ongoing niche development activity.
Active organizations in this dataset include the University of Surrey, Tavanta Therapeutics Inc., and Apichope Pharmaceutical Group Co., Ltd. Patent assignee activity is dominated by Pfizer Ltd/Inc with four total filings, followed by Asian generics manufacturers including IL Yang Pharma and GC BioPharma. No deal activity has been recorded for amlodipine in this dataset, consistent with its mature generic status.
Amlodipine Competitors on the L-Type Calcium Channel Blocker Axis
Ten competitors were identified on the same L-type calcium channel blocker and cardiovascular disease axis. The market is fragmented across multiple approved agents spanning six decades of development, with no novel-mechanism entrants identified in this dataset — competition remains entirely within the CCB class.
Competitor Drugs by First Approval Date — Amlodipine CCB Axis
Approved CCB competitors span from Verapamil (1965) through Levamlodipine Maleate (2003), with Amlodipine itself approved in 1993.
↗ Click bars to exploreAmlodipine Patent Filings by Thematic Category
Combination therapy and synthesis/salt chemistry each account for three of the ten retrieved patents, with stereoisomer IP and novel delivery making up the remainder.
↗ Click bars to exploreAmlodipine Indications: From Hypertension to Niche Repositioning
PatSnap Eureka records four indications for amlodipine. Hypertension and coronary artery disease are the primary approved indications; Fissure in Ano represents an emerging research-stage application based on amlodipine’s topical smooth muscle relaxation mechanism.
Hypertension
Hypertension is the primary approved indication for amlodipine, listed as an NDA/BLA approved use since the drug’s first approval on October 1, 1993. Amlodipine lowers systemic vascular resistance through peripheral arteriolar vasodilation via L-type calcium channel blockade. Its long plasma half-life of approximately 35–50 hours supports once-daily dosing in hypertensive patients.
CardiovascularCoronary Artery Disease
Coronary artery disease is a primary approved indication for amlodipine alongside hypertension. Amlodipine increases myocardial oxygen supply through coronary artery dilation, delivering an antianginal effect via L-type calcium channel blockade in cardiac myocytes. This mechanism supports its use in patients with stable angina and vasospastic angina associated with coronary artery disease.
CardiovascularFissure in Ano
Fissure in Ano is recorded as a research-stage or niche indication in the PatSnap Eureka dataset, exploiting amlodipine’s topical smooth muscle relaxation mechanism. Active organizations including Tavanta Therapeutics Inc. and the University of Surrey are listed as engaged with ongoing niche development activity. This represents a low-competition, potentially defensible niche based on the dataset intelligence.
Gastrointestinal / TopicalCardiovascular Combination Polypill
Patent records in the dataset capture amlodipine’s use in combination formulations targeting cardiovascular disease, including an ARB plus CCB combination (valsartan plus amlodipine, Novartis AG, EP1096932B1, 1999) and a statin plus CCB combination (rosuvastatin calcium plus amlodipine, Shanghai Sine Pharma Lab, CN101095680A, 2006). All retrieved combination therapy patents are now inactive, opening reformulation opportunities as polypill strategies gain regulatory acceptance globally.
CardiovascularOrganizations Shaping the Amlodipine Ecosystem
Pfizer Inc. is the originator of amlodipine, holding the largest patent footprint in this dataset with four total filings anchored by the foundational dihydropyridine composition patent (EP0290211B1, filed 1988). Active organizations including Tavanta Therapeutics Inc. and the University of Surrey suggest ongoing niche development activity not yet reflected in patent filings within this dataset.
Top Patent Assignees by Filing Count — Amlodipine
↗ Click bars to explorePfizer Inc.
Pfizer Inc. is the originator of amlodipine and holds the largest patent footprint in this dataset with four total filings. The foundational dihydropyridine composition-of-matter patent EP0290211B1 was filed on April 29, 1988, predating first approval by five years. All Pfizer-assigned patents are now inactive, consistent with the drug’s mature generic status.
United StatesTavanta Therapeutics, Inc.
Tavanta Therapeutics Inc. is listed as an active organization in the PatSnap Eureka dataset for amlodipine, alongside the University of Surrey and Apichope Pharmaceutical Group. Their activity is associated with niche development, specifically in areas such as the Fissure in Ano topical indication. No patent filings are attributed to Tavanta within the 10 retrieved patents in this dataset.
United StatesStrategic Outlook for Amlodipine: IP Gaps and Repositioning Signals
All 10 retrieved amlodipine patents are inactive, creating broad freedom-to-operate for generic manufacturers while simultaneously eliminating any proprietary moat without novel innovation. The dataset points to two primary areas of strategic relevance: stereoisomer and salt differentiation, and combination therapy reformulation.
Stereoisomer and Salt Differentiation Remains Primary IP Avenue
The Levamlodipine Maleate precedent — with filings by CSPC Ouyi Pharm Co Ltd and SK Chemicals Co Ltd — demonstrates that stereoisomer extraction and salt optimization have been exploited as IP differentiation strategies post-patent expiry. New entrants would need to identify unexplored salt or polymorph forms or novel enantiomeric applications to establish proprietary positions. The optical resolution patent CA2589099C (SK Chemicals, filed 2005) and the levamlodipine maleate preparation patent CN1278684C (CSPC Ouyi, filed 2004) both now inactive, signal the window of first-mover advantage in this sub-space has largely closed.
Combination Therapy Reformulation as Commercial Lever
Three combination-therapy patents covering ARB plus CCB (Novartis AG, valsartan, EP1096932B1, filed 1999) and statin plus CCB (Shanghai Sine Pharma Lab, rosuvastatin, CN101095680A, filed 2006; China Resources Saike Pharma, CN103127131A, filed 2012) are all inactive, opening reformulation opportunities. Polypill strategies are gaining regulatory acceptance globally, making these lapsed IP positions commercially relevant for BD and formulation teams. No novel-mechanism entrants have been identified in this dataset; all competitive activity remains within the CCB class.
Amlodipine vs. Levamlodipine Maleate: CCB Axis Comparison
Click any row to explore further in PatSnap Eureka.
| Dimension | Amlodipine | Levamlodipine Maleate |
|---|---|---|
| Drug Type | Small molecule | Small molecule |
| Primary Target | L-type calcium channel | L-type calcium channel |
| Mechanism of Action | L-type calcium channel blocker (racemate) | L-type calcium channel blocker (S-enantiomer) |
| Global Status | NDA/BLA approved | Approved (first approved 2003-07-24) |
| First Approved | 1993-10-01 | 2003-07-24 |
| Key Indications | Hypertension, Coronary Artery Disease, Fissure in Ano (research) | Hypertension (cardiovascular disease axis) |
| Originator | Pfizer Inc. | Not specified in dataset |
| Active Organizations | University of Surrey; Tavanta Therapeutics, Inc.; Apichope Pharmaceutical Group Co., Ltd. | CSPC Ouyi Pharm Co Ltd (key patent assignee CN1278684C) |
| Active Patents | 0 (all 10 retrieved patents inactive) | 0 (CN1278684C inactive) |
| IP Strategic Role | Core racemate; broad freedom-to-operate | Stereoisomer differentiation strategy post-expiry |
Amlodipine Drug Intelligence: Frequently Asked Questions
Amlodipine is a long-acting dihydropyridine L-type calcium channel blocker classified as a small molecule. It selectively blocks L-type voltage-gated calcium channels in vascular smooth muscle and cardiac myocytes, preventing calcium ion influx during membrane depolarization. This reduces intracellular calcium concentration, leading to vasodilation of peripheral arterioles and coronary arteries — lowering systemic vascular resistance and increasing myocardial oxygen supply. Its plasma half-life of approximately 35–50 hours supports once-daily dosing.
According to the PatSnap Eureka dataset, amlodipine has four recorded indications. The primary approved indications are hypertension and coronary artery disease, both holding NDA/BLA approved status since October 1, 1993. Fissure in Ano is recorded as a research-stage or niche indication based on the drug’s topical smooth muscle relaxation mechanism. A fourth indication is noted in the dataset but not specified in the retrieved records.
Pfizer Inc. is the originator of amlodipine, holding the foundational dihydropyridine composition-of-matter patent EP0290211B1 filed in 1988. Active organizations recorded in the PatSnap Eureka dataset include the University of Surrey, Tavanta Therapeutics Inc., and Apichope Pharmaceutical Group Co., Ltd. As a mature generic drug with zero active patents, Pfizer no longer holds exclusivity over the core compound.
The PatSnap Eureka dataset identifies 10 competitors on the same L-type calcium channel blocker and cardiovascular disease axis. Approved competitors include Verapamil Hydrochloride (first approved 1965), Amlodipine Besylate (1989), Efonidipine Hydrochloride Ethanolate (1994), and Levamlodipine Maleate (2003). Levamlodipine Maleate — the active S-enantiomer of amlodipine — is noted as the most strategically relevant competitor, enabling IP differentiation from the racemate. Four competitors including Fantofarone, Diperdipine, Elgodipine, and Pranidipine lack confirmed approval dates in the dataset.
Zero deals are retrieved in the PatSnap Eureka dataset for amlodipine. No licensing, acquisition, partnership, or financing transactions are recorded among retrieved records. The dataset notes this absence likely reflects amlodipine’s mature generic status, with commercial transactions at this stage typically occurring below standard deal-tracking thresholds or as part of broader generic portfolio transfers not captured in this dataset.
The PatSnap Eureka dataset retrieves 10 patents for amlodipine, with zero active patents identified. All IP has lapsed or expired, consistent with a drug approved in 1993 whose core composition-of-matter protection has long elapsed. Key assignees by filing count include Pfizer Ltd/Inc (4 patents), IL Yang Pharma Co Ltd (2), GC BioPharma Corp (2), Finechem Co Ltd (2), and Seoul National University R&DB Foundation (2). Thematic areas covered include synthesis and salt chemistry, combination therapy, stereoisomer IP, novel drug delivery, and core composition.
Data and insights on this page are based on a limited patent, clinical, and biopharma intelligence dataset and are for reference only. Figures may not represent the complete drug development landscape.