EXELON Drug Patent Profile

When do Exelon patents expire, and when can generic versions of Exelon launch?

Exelon is a drug marketed by Novartis and Sandoz and is included in three NDAs.

The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the rivastigmine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Exelon

A generic version of EXELON was approved as rivastigmine by ALVOGEN on August 31^st, 2015.

Summary for EXELON

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	41
Patent Applications:	5,092
Drug Prices:	Drug price information for EXELON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXELON
What excipients (inactive ingredients) are in EXELON?	EXELON excipients list
DailyMed Link:	EXELON at DailyMed

See drug prices for EXELON

Recent Clinical Trials for EXELON

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

Sponsor	Phase
Luye Pharma Group Ltd.	Phase 1
Ain Shams University	Phase 1/Phase 2
SocraTec R&D GmbH	Phase 1

See all EXELON clinical trials

Pharmacology for EXELON

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Paragraph IV (Patent) Challenges for EXELON

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
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 EXELON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-003	Apr 21, 2000		DISCN	Yes	No
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012	AB	RX	Yes	No
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-006	Apr 21, 2000		DISCN	Yes	No
Novartis	EXELON	rivastigmine tartrate	SOLUTION;ORAL	021025-001	Apr 21, 2000		DISCN	Yes	No

Expired US Patents for EXELON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-001	Jul 6, 2007
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-005	Aug 31, 2012
Sandoz	EXELON	rivastigmine	FILM, EXTENDED RELEASE;TRANSDERMAL	022083-002	Jul 6, 2007
Novartis	EXELON	rivastigmine tartrate	CAPSULE;ORAL	020823-005	Apr 21, 2000

EU/EMA Drug Approvals for EXELON

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

International Patents for EXELON

See the table below for patents covering EXELON around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	100569051
Turkey	200001688
Brazil	9906920
Netherlands	8800436

Supplementary Protection Certificates for EXELON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0193926	SPC/GB98/041	United Kingdom		PRODUCT NAME: RIVASTIGMINE, AS FREE BASE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5427501 19970731; CH 5427502 19970731; CH 5427503 19970731; CH 5427504 19970731; CH 5427505 19970731; CH 5427506 19970731; UK EU/1/98/066/001 19980512; UK EU/1/98/066/002 19980512; UK EU/1/98/066/003 19980512; UK EU/1/98/066/004 19980512; UK EU/1/98/066/005 19980512; UK EU/1/98/066/006 19980512; UK EU/1/98/092/023 19980512; UK EU/1/98/092/024 19980512; UK EU/1/98/092/025 19980512; UK EU/1/98/092/026 19980512; UK EU/1/98/066/025 19980512; UK EU/1/98/066/026 19980512; UK EU/1/98/092/019 19980512; UK EU/1/98/092/020 19980512; UK EU/1/98/092/021 19980512; UK EU/1/98/092/022 19980512; UK EU/1/98/0
0193926	98C0038	Belgium		PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
0193926	C980031	Netherlands		PRODUCT NAME: RIVASTIGMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RIVASTIGMINE WATERSTOFTAR- TRAAT; REGISTRATION NO/DATE: EU/1/98/066/001 - EU/1/98/066/012 19980512

EXELON Market Analysis and Financial Projection Experimental

Alzheimer’s Therapeutics Market: The Financial Trajectory and Market Dynamics of Exelon

Introduction

The Alzheimer’s therapeutics market is experiencing significant growth, driven by the increasing prevalence of Alzheimer’s disease and the demand for effective treatments. One of the key drugs in this market is Exelon, which has been a staple in the treatment of Alzheimer’s disease. Here, we will delve into the market dynamics and financial trajectory of Exelon.

Market Size and Growth

The global Alzheimer’s therapeutics market, which includes drugs like Exelon, is projected to grow substantially. By 2031, the market is expected to reach $13 billion, growing at a CAGR of 8.1% from 2021[1].

Exelon in the Alzheimer’s Therapeutics Market

Exelon, also known as rivastigmine, is a cholinesterase inhibitor used to treat mild to moderate dementia associated with Alzheimer’s disease and Parkinson’s disease. It is available in various forms, including capsules, oral solution, and transdermal patches.

Market Share and Dominance

The cholinesterase inhibitors segment, which includes Exelon, dominated the Alzheimer’s therapeutics market in 2021. This dominance is attributed to the strong availability of these therapeutics among key market players and their efficacy in managing Alzheimer’s symptoms[1].

Revenue Performance

Exelon has achieved significant revenue milestones. For instance, the Exelon Patch, despite being in a fully generic market, achieved $650 million in peak sales, primarily due to its lower gastrointestinal adverse events compared to other formulations[3].

Distribution Channels

The distribution of Exelon and other Alzheimer’s therapeutics is primarily through drug stores and retail pharmacies. In 2021, this segment dominated the market due to the easy availability of these drugs. However, the online pharmacy segment is expected to witness considerable growth, driven by the convenience it offers, especially for elderly and physically challenged patients[1].

Regional Outlook

North America is the largest regional market for Alzheimer’s therapeutics, including Exelon, due to the rising geriatric population and increased demand for these treatments. However, the Asia-Pacific region is registering the fastest growth rate, driven by developments in healthcare infrastructure and the presence of domestic companies[1].

Competitive Landscape

Exelon competes in a market with several other key players, including Eisai Co. Ltd., Novartis AG, Teva Pharmaceuticals Industries Ltd., and Biogen. The competitive landscape is characterized by the presence of robust drug candidates in the pipeline and the ongoing development of new treatments for Alzheimer’s disease[1].

Market Drivers

Several factors drive the demand for Exelon and other Alzheimer’s therapeutics:

• Rising Prevalence: The increasing prevalence of Alzheimer’s disease globally is a major driver. According to NCBI, around 121,499 deaths were recorded from Alzheimer’s disease in the U.S. in 2019[1].
• Awareness and Diagnosis: The growing awareness and diagnosis of Alzheimer’s disease have led to an increase in the number of patients seeking treatment.
• Technological Advancements: Improvements in healthcare infrastructure and the adoption of rapid testing and point-of-care diagnosis are also fueling market growth[4].

Challenges and Opportunities

Despite the growth, the market faces several challenges:

• Drug Dissatisfaction: There is a high rate of drug dissatisfaction and discontinuation among patients, creating an opportunity for improved treatment options. For instance, the AChEIs market, which includes Exelon, is characterized by high discontinuation rates due to side effects[3].
• Regulatory and Economic Factors: The market is influenced by regulatory requirements, economic conditions, and the impact of the COVID-19 pandemic[3].

Financial Performance of Exelon’s Manufacturer

Exelon Corporation, while not directly related to the drug Exelon, provides a broader context of financial stability and investment in healthcare and related sectors. Exelon Corporation has reported strong financial performance, with adjusted operating earnings increasing and significant investments planned in energy infrastructure. This financial stability can reflect positively on the overall healthcare sector, including pharmaceutical companies producing Alzheimer’s therapeutics[2][5].

Key Takeaways

• Market Growth: The Alzheimer’s therapeutics market, including Exelon, is expected to reach $13 billion by 2031.
• Dominance of Cholinesterase Inhibitors: Exelon, as a cholinesterase inhibitor, dominates the market due to its efficacy and availability.
• Regional Dynamics: North America is the largest market, but Asia-Pacific is growing rapidly.
• Market Drivers: Rising prevalence, awareness, and technological advancements drive the market.
• Challenges and Opportunities: High drug dissatisfaction rates and regulatory challenges present opportunities for improved treatments.

FAQs

What is the projected market size of the Alzheimer’s therapeutics market by 2031?

The global Alzheimer’s therapeutics market is projected to reach $13 billion by 2031, growing at a CAGR of 8.1% from 2021[1].

Which segment dominates the Alzheimer’s therapeutics market?

The cholinesterase inhibitors segment, which includes Exelon, dominates the market due to its strong availability and efficacy[1].

What are the key distribution channels for Alzheimer’s therapeutics like Exelon?

The key distribution channels are drug stores and retail pharmacies, with online pharmacies expected to grow significantly[1].

Which region offers the most lucrative opportunities for Alzheimer’s therapeutics?

North America offers the most lucrative opportunities due to the rising geriatric population, but Asia-Pacific is growing at the fastest rate[1].

What are the main challenges faced by the Alzheimer’s therapeutics market?

High drug dissatisfaction and discontinuation rates, regulatory challenges, and economic factors are significant challenges[3].

Sources

1. Allied Market Research: Alzheimer's Therapeutics Market Statistics and Forecast - 2031
2. Exelon Corporation: Exelon Reports Third Quarter 2024 Results
3. Alpha Cognition: Corporate Presentation
4. Reports and Data: Alzheimer's Pipeline Drug Market Analysis, Industry Size, Share ...
5. Exelon Corporation: Exelon Reports Fourth Quarter and Full Year 2023 Results and Initiates 2024 Financial Outlook