Rivastigmine tartrate - Generic Drug Details

What are the generic sources for rivastigmine tartrate and what is the scope of patent protection?

Rivastigmine tartrate is the generic ingredient in two branded drugs marketed by Novartis, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for rivastigmine tartrate. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for rivastigmine tartrate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	2
Patent Applications:	4,560
Drug Prices:	Drug price trends for rivastigmine tartrate
What excipients (inactive ingredients) are in rivastigmine tartrate?	rivastigmine tartrate excipients list
DailyMed Link:	rivastigmine tartrate at DailyMed

See drug prices for rivastigmine tartrate

Recent Clinical Trials for rivastigmine tartrate

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

Sponsor	Phase
Duke University	Phase 1/Phase 2
Taishoff Family Foundation	Phase 1/Phase 2
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Phase 1/Phase 2

See all rivastigmine tartrate clinical trials

Generic filers with tentative approvals for RIVASTIGMINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		2MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rivastigmine tartrate

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for rivastigmine tartrate

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RIVASTIGMINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXELON	Oral Solution	rivastigmine tartrate	2 mg/mL	021025	1	2004-11-05
EXELON	Capsules	rivastigmine tartrate	1.5 mg, 3 mg, 4.5 mg and 6 mg	020823	3	2004-04-21

US Patents and Regulatory Information for rivastigmine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	204572-003	Mar 25, 2016	AB	RX	No	No
Aurobindo Pharma	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	204572-002	Mar 25, 2016	AB	RX	No	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000		DISCN	Yes	No
Chartwell Rx	RIVASTIGMINE TARTRATE	rivastigmine tartrate	CAPSULE;ORAL	207797-001	Sep 28, 2017	AB	RX	No	No

Expired US Patents for rivastigmine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-003	Apr 21, 2000

Rivastigmine tartrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rivastigmine Tartrate

Introduction

Rivastigmine tartrate, a cholinesterase inhibitor, is a crucial medication in the treatment of Alzheimer’s and Parkinson’s diseases. The market for this drug is driven by several key factors, which are influencing its financial trajectory.

Increasing Geriatric Population

One of the primary drivers of the rivastigmine market is the increasing geriatric population worldwide. As people age, the risk of suffering from dementia and other neurodegenerative diseases significantly increases. According to the Alzheimer’s Association, the risk of dementia doubles every five years after the age of 65[1].

Prevalence of Neurodegenerative Diseases

The growing prevalence of Alzheimer’s and Parkinson’s diseases is a major factor boosting the demand for rivastigmine. These diseases are becoming more common due to an aging population and other health factors such as cardiovascular diseases, diabetes, and hypertension. The incidence of cardiovascular diseases, for example, was around 22.5 per 1,000 persons worldwide in 2013, which increases the risk of dementia[1].

Regional Insights

The rivastigmine market is geographically segmented into North America, Latin America, Asia Pacific, Europe, Middle East, and Africa. North America holds the largest share in the global rivastigmine market, primarily due to the well-established healthcare infrastructure and high prevalence of Alzheimer’s and Parkinson’s diseases in this region. Europe follows closely, driven by an aging population, with around 25% of the population in Europe aged 60 years or above in 2017[1].

North America

North America dominates the market, with a significant market share, particularly in the United States. The region's advanced healthcare infrastructure, high healthcare spending, and favorable reimbursement policies contribute to its leading position. In 2024, the North American rivastigmine transdermal patches market was estimated at USD 3,192.48 million and is expected to grow at a CAGR of 3.2% from 2024 to 2031[3].

Europe

Europe holds a substantial market share, with a market size of USD 2,394.36 million in 2024 for rivastigmine transdermal patches. The region is expected to grow at a CAGR of 3.5% from 2024 to 2031, driven by an aging population and increasing prevalence of neurodegenerative diseases[3].

Asia Pacific

The Asia Pacific region is expected to experience significant growth, with the highest CAGR among all regions. This growth is fueled by a rapidly aging population and rising incidence of neurodegenerative diseases. Improving healthcare infrastructure and increasing investment in healthcare technologies are also key drivers[3].

Market Size and Growth

The global rivastigmine transdermal patches market size was estimated at USD 7,981.2 million in 2024 and is projected to grow to USD 11,230.3 million by 2031, with a CAGR of 5.00% from 2024 to 2031. This growth is driven by the increasing demand for non-invasive treatment options and the rising awareness of neurodegenerative disorders[3].

Competitive Landscape

The rivastigmine market is competitive, with major players such as Novartis Europharm Limited, Actavis Pharma, Apotex Corporation, Aurobindo Pharm Ltd, Teva Pharmaceuticals Industries Ltd, Dr. Reddy’s Laboratories, and Macleods. These companies are focused on product development and approvals to enhance their market share. For instance, the U.S. FDA approved Exelon (Rivastigmine tartarate) developed by Novartis Europharm Limited in 2007 for the treatment of Alzheimer's and Parkinson's disease[1].

Formulation and Delivery

Rivastigmine can be administered orally or through transdermal patches, which offers convenience and improved compliance. The transdermal patches are particularly popular due to their ease of use and steady drug delivery. This formulation has contributed significantly to the market growth, especially in regions where patient compliance is a challenge[1][3].

Regulatory Approvals

Regulatory approvals play a crucial role in the market dynamics of rivastigmine. The FDA approval of Exelon in 2007 marked a significant milestone, and subsequent approvals have continued to support market growth. Regulatory bodies ensure that the drug meets safety and efficacy standards, which enhances consumer trust and drives market expansion[5].

Challenges and Opportunities

Despite the growth drivers, the rivastigmine market faces challenges such as side effects and the need for continuous monitoring. However, these challenges also present opportunities for innovation, such as the development of new formulations like intranasal solid lipid nanoparticles, which aim to enhance drug delivery and reduce side effects[2].

Financial Projections

The financial trajectory of the rivastigmine market is promising, with significant growth projected over the next several years. Here are some key financial projections:

• Global Market Size: Expected to grow from USD 7,981.2 million in 2024 to USD 11,230.3 million by 2031, with a CAGR of 5.00%[3].
• North America: Projected to grow at a CAGR of 3.2% from 2024 to 2031, with a market size of USD 3,192.48 million in 2024[3].
• Europe: Expected to grow at a CAGR of 3.5% from 2024 to 2031, with a market size of USD 2,394.36 million in 2024[3].
• Asia Pacific: Projected to grow at the highest CAGR of 7.0% from 2024 to 2031, with a market size of USD 1,835.68 million in 2024[3].

Key Takeaways

• The rivastigmine market is driven by an increasing geriatric population and the prevalence of neurodegenerative diseases.
• North America and Europe are the leading regions, with Asia Pacific expected to show significant growth.
• The market is expected to grow from USD 7,981.2 million in 2024 to USD 11,230.3 million by 2031.
• Transdermal patches are a popular formulation due to their convenience and steady drug delivery.
• Regulatory approvals and continuous innovation are crucial for market growth.

FAQs

What is rivastigmine tartrate used for?

Rivastigmine tartrate is used for the treatment of mild to moderate dementia associated with Alzheimer’s and Parkinson’s diseases.

Which regions dominate the rivastigmine market?

North America and Europe currently dominate the rivastigmine market, with Asia Pacific expected to show significant growth in the future.

What is the projected growth rate of the global rivastigmine transdermal patches market?

The global rivastigmine transdermal patches market is expected to grow at a CAGR of 5.00% from 2024 to 2031.

What are the key drivers of the rivastigmine market?

The key drivers include an increasing geriatric population, the prevalence of neurodegenerative diseases, and the convenience of transdermal patches.

Which companies are major players in the rivastigmine market?

Major players include Novartis Europharm Limited, Actavis Pharma, Apotex Corporation, Aurobindo Pharm Ltd, Teva Pharmaceuticals Industries Ltd, Dr. Reddy’s Laboratories, and Macleods.

Sources

1. Coherent Market Insights: Rivastigmine Market - Share, Size and Industry Analysis.
2. Frontiers in Aging Neuroscience: QbD-based rivastigmine tartrate-loaded solid lipid nanoparticles for enhanced intranasal delivery to the brain for Alzheimer's therapeutics.
3. Cognitive Market Research: The global rivastigmine transdermal patches market report.
4. Accessdata.fda.gov: Exelon (Rivastigmine tartrate) Prescribing Information.