ADLARITY Drug Patent Profile

Which patents cover Adlarity, and when can generic versions of Adlarity launch?

Adlarity is a drug marketed by Corium and is included in one NDA. There are nine patents protecting this drug.

This drug has eighty-nine patent family members in eleven countries.

The generic ingredient in ADLARITY is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adlarity

A generic version of ADLARITY was approved as donepezil hydrochloride by AUROBINDO on May 31^st, 2011.

Summary for ADLARITY

International Patents:	89
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	160
Patent Applications:	4,015
Drug Prices:	Drug price information for ADLARITY
What excipients (inactive ingredients) are in ADLARITY?	ADLARITY excipients list
DailyMed Link:	ADLARITY at DailyMed

See drug prices for ADLARITY

Pharmacology for ADLARITY

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

US Patents and Regulatory Information for ADLARITY

ADLARITY is protected by nine US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		RX	Yes	No			Y
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes			Y
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		RX	Yes	No			Y
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		RX	Yes	No			Y
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes			Y
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-001	Mar 11, 2022		RX	Yes	No			Y

International Patents for ADLARITY

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

Country	Patent Number	Title	Estimated Expiration
Australia	2017302306	Transdermal formulation and delivery method of low solubility or unstable unionized neutral drugs by in situ salt-to-neutral drug conversion of salt drug
Japan	2019523270	ドネペジル経皮送達システム
South Korea	20190032512	도네페질 경피 전달 시스템
Japan	2019504052	長期間経皮投与のためのシステムおよび方法
Japan	7071958
Mexico	2022006681	SISTEMA DE SUMINISTRO TRANSDERMICO DE DONEPEZILO. (DONEPEZIL TRANSDERMAL DELIVERY SYSTEM.)
Canada	3032103	SYSTEMES D'ADMINISTRATION TRANSDERMIQUE DE MEMANTINE (MEMANTINE TRANSDERMAL DELIVERY SYSTEMS)

Supplementary Protection Certificates for ADLARITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296560	2/1998	Austria		PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
0296560	SPC/GB97/023	United Kingdom		PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214

ADLARITY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ADLARITY

Introduction to ADLARITY

ADLARITY, developed by Corium, LLC, is a groundbreaking once-weekly transdermal system designed to deliver donepezil, a commonly prescribed medication for Alzheimer's dementia. This innovative treatment has entered a competitive market with significant potential for growth.

Market Context: Alzheimer's Therapeutics

The global Alzheimer's therapeutics market is expanding rapidly, driven by the increasing prevalence of Alzheimer's disease. As of 2023, this market was valued at USD 4.82 billion and is projected to reach USD 7.52 billion by 2031[1].

Prevalence and Demand

Alzheimer's disease affects a substantial and growing population. Approximately 6.2 million Americans aged 65 and older had Alzheimer's disease in 2021, and this number is expected to double to about 13.8 million by 2060. This demographic shift increases the demand for effective therapeutics, making the market highly lucrative[1].

Competitive Landscape

ADLARITY enters a market dominated by cholinesterase inhibitors, which held a 50% market share in 2023. However, it differentiates itself through its once-weekly transdermal application, contrasting with other cholinesterase inhibitors that require more frequent daily oral or transdermal dosing[2].

Unique Selling Proposition

The transdermal system of ADLARITY, utilizing Corium's proprietary CORPLEX technology, offers continuous, controlled, and sustained release of donepezil over a week. This convenience and consistency are expected to improve patient compliance and reduce the burden on caregivers[5].

Regulatory Approval and Launch

ADLARITY received FDA approval in March 2022 and was launched in the U.S. in September 2022. It has gained first-line formulary coverage for patients with some health plans, indicating strong initial acceptance[5].

Financial Projections

• U.S. Market: GlobalData forecasts that cholinesterase inhibitors, including ADLARITY, will contribute a combined $895.9 million to the U.S. Alzheimer's disease market by 2030. Specifically, ADLARITY is expected to exceed $200 million in U.S. sales by 2030[2].
• Asian Markets: Through an exclusive license agreement with Lotus Pharmaceutical, ADLARITY will be commercialized in ten markets across Asia. The market size for donepezil in these markets is estimated at USD 185 million, with the patient population expected to increase from 3 million in 2015 to 5.5 million by 2030[4].

Market Growth Drivers

• Aging Population: The increasing age of the global population is a significant driver, as older individuals are more likely to develop Alzheimer's disease.
• Innovative Delivery System: The once-weekly transdermal patch offers a more convenient and tolerable option compared to traditional oral or daily transdermal treatments.
• Strategic Partnerships: Collaborations, such as the one between Corium and Lotus Pharmaceutical, expand the reach and availability of ADLARITY in new markets[4].

Market Challenges

• Competition: ADLARITY faces competition from established cholinesterase inhibitors and other treatments for Alzheimer's disease.
• Regulatory Hurdles: While ADLARITY has received FDA approval, regulatory processes in new markets can be challenging and time-consuming[2].

Key Players and Partnerships

• Corium, LLC: The developer and manufacturer of ADLARITY, known for its expertise in transdermal technology.
• Lotus Pharmaceutical: Partnered with Corium for the exclusive commercialization of ADLARITY in ten Asian markets[4].

Recent Developments

• Expansion into Asia: The exclusive license agreement with Lotus Pharmaceutical marks a significant expansion into the Asian market, targeting countries such as Taiwan, South Korea, and others[4].
• Clinical and Technological Advancements: Corium continues to develop its CORPLEX technology, focusing on other CNS therapies that leverage this innovative delivery system[5].

Conclusion

ADLARITY is poised to make a significant impact in the Alzheimer's therapeutics market, driven by its innovative delivery system, strategic partnerships, and growing demand due to the increasing prevalence of Alzheimer's disease. With projected sales exceeding $200 million in the U.S. by 2030 and a strong presence in Asian markets, ADLARITY is a key player in the financial trajectory of Alzheimer's treatments.

Key Takeaways

• Market Growth: The Alzheimer's therapeutics market is expected to grow significantly, driven by the aging population and increasing prevalence of the disease.
• Innovative Delivery: ADLARITY's once-weekly transdermal system offers a convenient and well-tolerated option for patients.
• Financial Projections: ADLARITY is forecasted to exceed $200 million in U.S. sales by 2030 and has a substantial market potential in Asia.
• Strategic Partnerships: Collaborations with companies like Lotus Pharmaceutical are crucial for expanding market reach.
• Regulatory and Competitive Challenges: Despite FDA approval, ADLARITY must navigate regulatory processes in new markets and compete with established treatments.

FAQs

What is ADLARITY and how does it work?

ADLARITY is a once-weekly transdermal system that delivers donepezil, a medication for Alzheimer's dementia. It uses Corium's proprietary CORPLEX technology for continuous, controlled, and sustained release of the drug over a week.

What is the market size for ADLARITY in the U.S. by 2030?

ADLARITY is expected to exceed $200 million in U.S. sales by 2030, contributing to the combined $895.9 million forecast for cholinesterase inhibitors in the U.S. Alzheimer's disease market[2].

Which markets in Asia will ADLARITY be commercialized in?

ADLARITY will be commercialized in ten markets across Asia, including Taiwan, South Korea, Hong Kong, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam, through an exclusive license agreement with Lotus Pharmaceutical[4].

What are the key drivers for the growth of ADLARITY in the market?

The key drivers include the aging population, the innovative once-weekly transdermal delivery system, and strategic partnerships that expand its market reach.

How does ADLARITY differentiate itself from other cholinesterase inhibitors?

ADLARITY differentiates itself through its once-weekly transdermal application, which is more convenient and less frequent than other cholinesterase inhibitors that require daily oral or transdermal dosing[2].

Sources

1. Towards Healthcare: Alzheimer's Therapeutics Market: Size, Share, Trends, and Forecast (2023-2031)[1].
2. The Pharma Letter: Alzheimer's patch Adlarity forecast to exceed $200 million in US sales by 2030[2].
3. Mordor Intelligence: Drug Delivery Devices Global Market: Forecast, Growth, and Trends[3].
4. Biospace: Corium and Lotus Pharmaceutical Enter into Exclusive License Agreement for Innovative Alzheimer's Disease Treatment ADLARITY in Multiple Markets Across Asia[4].
5. PR Newswire: Corium Launches ADLARITY (donepezil transdermal system) for Patients with Alzheimer's Dementia[5].