Rivastigmine - Generic Drug Details

What are the generic sources for rivastigmine and what is the scope of freedom to operate?

Rivastigmine is the generic ingredient in three branded drugs marketed by Sandoz, Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, 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 eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for rivastigmine. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for rivastigmine

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	18
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	101
Patent Applications:	6,959
Drug Prices:	Drug price trends for rivastigmine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for rivastigmine
What excipients (inactive ingredients) are in rivastigmine?	rivastigmine excipients list
DailyMed Link:	rivastigmine at DailyMed

See drug prices for rivastigmine

Recent Clinical Trials for rivastigmine

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

Sponsor	Phase
NeuroSense Therapeutics Ltd.	Phase 2
Luye Pharma Group Ltd.	Phase 1
Tergooi Hospital	Phase 4

See all rivastigmine clinical trials

Generic filers with tentative approvals for RIVASTIGMINE

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

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for rivastigmine

Cholinesterase Inhibitors

Neuroprotective Agents

Anatomical Therapeutic Chemical (ATC) Classes for rivastigmine

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

Paragraph IV (Patent) Challenges for RIVASTIGMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXELON	Transdermal System Extended-release	rivastigmine	13.3 mg/24 hr	022083	1	2013-01-22
EXELON	Transdermal System Extended-release	rivastigmine	4.6 mg/24 hr and 9.5 mg/24 hr	022083	1	2011-04-27

US Patents and Regulatory Information for rivastigmine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Technologies	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	205622-003	Jun 20, 2018	AB	RX	No	No
Mylan Technologies	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	205622-002	Jun 20, 2018	AB	RX	No	No
Alvogen	RIVASTIGMINE	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	204403-001	Sep 3, 2015	AB	RX	No	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000		DISCN	Yes	No

Expired US Patents for rivastigmine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012	6,316,023
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007	4,948,807
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012	5,602,176
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007	4,948,807

EU/EMA Drug Approvals for rivastigmine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Actavis Group PTC ehf	Rivastigmine Actavis	rivastigmine	EMEA/H/C/002036 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	yes	no	no	2011-06-16
Krka, d.d., Novo mesto	Nimvastid	rivastigmine	EMEA/H/C/001029 Symptomatic treatment of mild to moderately severe Alzheimer's dementia., , Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.,	Authorised	yes	no	no	2009-05-11
1 A Pharma GmbH	Rivastigmine 1 A Pharma	rivastigmine	EMEA/H/C/001181 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	2009-12-11
Novartis Europharm Limited	Exelon	rivastigmine	EMEA/H/C/000169 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.	Authorised	no	no	no	1998-05-11

Rivastigmine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rivastigmine

Introduction

Rivastigmine, a cholinesterase inhibitor, is widely used in the treatment of Alzheimer's and Parkinson's diseases. The market for rivastigmine, particularly in its transdermal patch form, is experiencing significant growth driven by several key factors. Here, we delve into the market dynamics, financial trajectory, and the challenges faced by this market.

Global Market Size and Growth

The global rivastigmine transdermal patches market was estimated to be USD 7981.2 million in 2024, with a projected compound annual growth rate (CAGR) of 5% from 2024 to 2031[1].

Regional Market Share

• North America: This region dominates the market, holding more than 40% of the global revenue, with a market size of USD 3192.48 million in 2024. It is expected to grow at a CAGR of 3.2% during the forecast period[1].
• Europe: Europe holds around 30% of the global revenue, with a market size of USD 2394.36 million in 2024, and is expected to grow at a CAGR of 3.5% from 2024 to 2031[1].
• Asia-Pacific: This region is expected to see the highest CAGR of 7.0% from 2024 to 2031, driven by a rapidly aging population and improving healthcare infrastructure[1].
• Latin America and Middle East & Africa: These regions hold smaller market shares but are also expected to grow, with CAGRs of 4.4% and 4.7%, respectively[1].

Drivers of Market Growth

Increasing Prevalence of Neurodegenerative Diseases

The rising incidence of Alzheimer's and Parkinson's diseases, particularly in aging populations, is a significant driver of the rivastigmine market. As the global population ages, the demand for effective treatments for these diseases is increasing[1][3].

Advanced Healthcare Infrastructure

Regions like North America and Europe benefit from well-established healthcare infrastructures, advanced research and development, and favorable reimbursement policies. These factors enhance the adoption of rivastigmine transdermal patches[1].

Growing Awareness and Preference for Non-Invasive Treatments

There is a growing awareness of dementia and a shifting preference towards convenient and non-invasive drug delivery methods. Transdermal patches offer a more patient-friendly option compared to traditional oral medications, contributing to their increasing demand[1].

Restraints to Market Growth

High Cost of Transdermal Patches

The high manufacturing and production costs of transdermal patches result in higher retail prices, making them less accessible to patients, especially in developing regions. Limited insurance coverage further exacerbates this issue, leading to lower adoption rates[1].

Impact of the COVID-19 Pandemic

The COVID-19 pandemic disrupted healthcare services and supply chains, leading to delayed diagnoses and treatments for Alzheimer’s and Parkinson’s diseases. This disruption negatively impacted the market for rivastigmine transdermal patches[1].

Cost-Effectiveness

Studies have shown that rivastigmine, both in patch and capsule forms, can be cost-effective compared to best supportive care (BSC). For instance, a study in the UK found that the incremental costs per Quality Adjusted Life Year (QALY) for rivastigmine patches were £10,579 and £9,114 when incorporating activities of daily living (ADL) scores, indicating that these treatments can offer significant value despite their higher upfront costs[2].

Market Segmentation

The rivastigmine market is segmented based on type (oral capsules and transdermal patches) and application (Alzheimer's disease and Parkinson's disease).

• Oral Market: The rivastigmine oral market was valued at USD 1.9 billion in 2023 and is expected to reach USD 3.5 billion by 2031, growing at a CAGR of 8.6% from 2024 to 2031[4].
• Transdermal Patches: As mentioned, the transdermal patches market is expected to grow at a CAGR of 5% from 2024 to 2031[1].

Financial Trajectory

The financial trajectory of the rivastigmine market is positive, driven by the increasing demand for effective treatments for neurodegenerative diseases. Here are some key financial highlights:

• Global Revenue: The global rivastigmine transdermal patches market is expected to grow from USD 7981.2 million in 2024 to a higher figure by 2031, driven by a CAGR of 5%[1].
• Regional Growth: North America, Europe, and Asia-Pacific are expected to contribute significantly to this growth, with Asia-Pacific showing the highest CAGR[1].

Future Outlook

The future outlook for the rivastigmine market is promising, with several factors contributing to its growth:

• Increasing Investment in Healthcare: Improving healthcare infrastructure and increasing investment in healthcare technologies, especially in the Asia-Pacific region, will enhance access to treatments[1].
• Research and Development: Continuous research and development in drug delivery systems and the potential for new indications could further expand the market[3].

Challenges and Opportunities

Challenges

• High Costs: The high cost of transdermal patches remains a significant challenge, limiting accessibility in many regions[1].
• Economic Impact of Pandemics: Future pandemics or global health crises could disrupt the market, as seen during the COVID-19 pandemic[1].

Opportunities

• Growing Demand in Emerging Markets: The increasing awareness and demand for non-invasive treatments in emerging markets present significant opportunities for growth[1].
• Advancements in Technology: Improvements in drug delivery systems and the development of more cost-effective manufacturing processes could make rivastigmine more accessible and affordable[3].

Key Takeaways

• The global rivastigmine transdermal patches market is growing, driven by the increasing prevalence of neurodegenerative diseases and advancements in healthcare infrastructure.
• North America and Europe are major contributors to the market, but Asia-Pacific is expected to show the highest growth rate.
• High costs and limited insurance coverage are significant restraints to market growth.
• Rivastigmine treatments have been shown to be cost-effective in various studies.
• The market is segmented by type and application, with both oral and transdermal forms showing promising growth trajectories.

FAQs

Q: What is the current market size of the global rivastigmine transdermal patches market? A: The global rivastigmine transdermal patches market size was estimated at USD 7981.2 million in 2024[1].

Q: Which region dominates the rivastigmine transdermal patches market? A: North America currently dominates the market, holding more than 40% of the global revenue[1].

Q: What is the projected CAGR for the rivastigmine transdermal patches market from 2024 to 2031? A: The market is expected to grow at a CAGR of 5% from 2024 to 2031[1].

Q: Are rivastigmine treatments cost-effective? A: Yes, studies have shown that rivastigmine treatments, both in patch and capsule forms, can be cost-effective compared to best supportive care[2].

Q: How has the COVID-19 pandemic impacted the rivastigmine transdermal patches market? A: The pandemic has negatively impacted the market due to disruptions in healthcare services and supply chains, leading to delayed diagnoses and treatments[1].

Sources

1. Cognitive Market Research - Global Rivastigmine Transdermal Patches Market Report.
2. PubMed - Assessing the cost-effectiveness of the rivastigmine transdermal patch in Alzheimer's disease management.
3. Market Research Intellect - Global Rivastigmine Tartrate Sales Market Size, Scope And Forecast Report.
4. Market Research Intellect - Rivastigmine Oral Market Size, Share | Growth Report, 2031.
5. NCBI - Clinical and cost-effectiveness of donepezil, rivastigmine, and galantamine.