ISRADIPINE - Generic Drug Details

What are the generic drug sources for isradipine and what is the scope of patent protection?

Isradipine is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Elite Labs Inc, Watson Labs Teva, Glaxosmithkline Llc, and Norvium Bioscience, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for isradipine. Four suppliers are listed for this compound.

Summary for ISRADIPINE

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	12
Patent Applications:	7,299
Drug Prices:	Drug price trends for ISRADIPINE
What excipients (inactive ingredients) are in ISRADIPINE?	ISRADIPINE excipients list
DailyMed Link:	ISRADIPINE at DailyMed

See drug prices for ISRADIPINE

Recent Clinical Trials for ISRADIPINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Menarini International Operations Luxembourg SA	Phase 4
University of Texas at Austin	Early Phase 1
National Institute on Drug Abuse (NIDA)	Early Phase 1

See all ISRADIPINE clinical trials

Pharmacology for ISRADIPINE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for ISRADIPINE

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ISRADIPINE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for ISRADIPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Elite Labs Inc	ISRADIPINE	isradipine	CAPSULE;ORAL	077169-002	Apr 24, 2006	AB	RX	No	No
Watson Labs Teva	ISRADIPINE	isradipine	CAPSULE;ORAL	077317-001	Jan 5, 2006	AB	RX	No	No
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990		DISCN	Yes	No

Expired US Patents for ISRADIPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994

ISRADIPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Isradipine

Introduction to Isradipine

Isradipine, a dihydropyridine derivative, is a calcium channel blocker that inhibits the inward calcium flux through 'slow' channels of cardiac and vascular tissue. This action results in potent coronary, cerebral, and peripheral vasodilatation, making it an effective treatment for hypertension, chronic stable angina, and potentially congestive heart failure[3].

Market Size and Growth

The global market for calcium channel blockers, which includes isradipine, is substantial and growing. As of 2022, the global calcium channel blocker drugs market was valued at US$ 14,285.3 million and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.2% from 2022 to 2030, reaching a projected value of US$ 21,489.7 million by 2030[1].

Segment Contribution

Within the broader antihypertensive drugs market, calcium channel blockers play a significant role. The global antihypertensive drugs market, which includes various drug classes such as diuretics, ACE inhibitors, beta-blockers, and calcium channel blockers, was valued at USD 23.61 billion in 2023 and is expected to reach USD 34.71 billion by 2033, growing at a CAGR of 3.93% from 2024 to 2033[4].

Regional Market Dynamics

North America dominates the antihypertensive drugs market, including calcium channel blockers. The region's market size was USD 8.97 billion in 2023 and is projected to reach USD 13.36 billion by 2033, growing at a CAGR of 4.13% from 2024 to 2033. The high prevalence of hypertension in this region drives the demand for antihypertensive medications, including isradipine[4].

Pharmacological Advantages

Isradipine offers several pharmacological advantages that contribute to its market appeal. It has minimal cardiodepressant activity, selective action on coronary and skeletal muscle vasculature, and a prolonged vasodilatory action. These characteristics make it an effective antihypertensive agent suitable for long-term treatment of mild to moderate hypertension, either as monotherapy or in combination with other medications like beta-blockers, diuretics, or ACE inhibitors[3].

Clinical Applications

Isradipine is used in the treatment of various cardiovascular conditions, including:

• Hypertension: Effective in managing mild to moderate hypertension.
• Chronic Stable Angina: Preliminary findings suggest its potential role in treating this condition.
• Congestive Heart Failure: May have a role in treating this condition, although further clarification is needed[3].

Adverse Effects and Tolerability

The adverse effects associated with isradipine are generally mild, transient, and well-tolerated. These effects are similar to those encountered with other calcium channel blockers, making it a relatively safe option for long-term use[3].

Distribution Channels

The distribution of isradipine, like other antihypertensive drugs, is primarily through retail pharmacies, hospital pharmacies, and increasingly through online pharmacies. Hospital pharmacies dominate the distribution channel due to their role in providing effective and safe medication therapy for hospitalized patients. However, the online pharmacy segment is expected to grow rapidly due to its convenience and practical shopping methods[4].

Financial Trajectory of Related Companies

While specific financial data for isradipine is not readily available, companies involved in the production and distribution of calcium channel blockers and other antihypertensive drugs often exhibit robust financial health. For example, Elite Pharmaceuticals, which produces various pharmaceutical products, has seen significant revenue growth and positive cash flow. Their revenues have increased by 33% in Q2 2024, with operating income more than doubling from the previous year. This growth trajectory is indicative of the overall market's potential for calcium channel blockers like isradipine[2].

Key Drivers and Restraints

• Increasing Prevalence of Hypertension: The growing number of people suffering from hypertension is a major driver for the calcium channel blocker market, including isradipine[1].
• Aging Population: An increasing senior population also contributes to the demand for antihypertensive medications[4].
• Competition from Other Drug Classes: The presence of other effective antihypertensive drug classes, such as ACE inhibitors and beta-blockers, can act as a restraint for the growth of calcium channel blockers[4].

Future Outlook

Given the pharmacological advantages and the growing demand for antihypertensive medications, isradipine is likely to continue playing a significant role in the treatment of hypertension and related cardiovascular conditions. The market's growth trajectory, driven by increasing prevalence of hypertension and an aging population, suggests a bright future for isradipine and other calcium channel blockers.

"Isradipine appears to offer a useful alternative to other dihydropyridine derivatives currently employed for the treatment of mild to moderate hypertension and, to a lesser extent, chronic stable angina."[3]

Key Takeaways

• Market Growth: The global calcium channel blocker market is expected to grow at a CAGR of 5.2% from 2022 to 2030.
• Pharmacological Advantages: Isradipine has minimal cardiodepressant activity and selective action on coronary and skeletal muscle vasculature.
• Clinical Applications: Effective in treating hypertension, chronic stable angina, and potentially congestive heart failure.
• Distribution Channels: Primarily distributed through retail and hospital pharmacies, with a growing online pharmacy segment.
• Financial Health: Companies producing antihypertensive drugs, including calcium channel blockers, often exhibit robust financial growth.

FAQs

1. What is isradipine used for?

   • Isradipine is used for the treatment of hypertension, chronic stable angina, and potentially congestive heart failure.

2. What are the pharmacological advantages of isradipine?

   • Isradipine has minimal cardiodepressant activity, selective action on coronary and skeletal muscle vasculature, and a prolonged vasodilatory action.

3. How does the global market for calcium channel blockers look?

   • The global calcium channel blocker market was valued at US$ 14,285.3 million in 2022 and is expected to grow at a CAGR of 5.2% from 2022 to 2030.

4. What are the key drivers for the growth of the calcium channel blocker market?

   • The increasing prevalence of hypertension and an aging population are major drivers for the market.

5. How is isradipine distributed?

   • Isradipine is primarily distributed through retail and hospital pharmacies, with a growing segment of online pharmacies.

Sources

1. Coherent Market Insights - Calcium Channel Blocker Drugs Market Size by 2030
2. Investing.com - Earnings call: Elite Pharmaceuticals posts robust Q2 growth, eyes future
3. PubMed - Isradipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease.
4. Precedence Research - Antihypertensive Drugs Market Size to Hit USD 34.71 Bn by 2033