RAZADYNE Drug Patent Profile

Which patents cover Razadyne, and what generic alternatives are available?

Razadyne is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Razadyne

A generic version of RAZADYNE was approved as galantamine hydrobromide by BARR on August 28^th, 2008.

Summary for RAZADYNE

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	21
Patent Applications:	4,180
Drug Prices:	Drug price information for RAZADYNE
What excipients (inactive ingredients) are in RAZADYNE?	RAZADYNE excipients list
DailyMed Link:	RAZADYNE at DailyMed

See drug prices for RAZADYNE

Recent Clinical Trials for RAZADYNE

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 1
Doris Duke Charitable Foundation	Phase 1/Phase 2
Vanderbilt University Medical Center	Phase 1/Phase 2

See all RAZADYNE clinical trials

Paragraph IV (Patent) Challenges for RAZADYNE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAZADYNE	Tablets	galantamine hydrobromide	4 mg, 8 mg and 12 mg	021169	14	2005-02-28

US Patents and Regulatory Information for RAZADYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	SOLUTION;ORAL	021224-001	Jun 22, 2001		DISCN	No	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-001	Feb 28, 2001		DISCN	Yes	No
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001		DISCN	Yes	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005		DISCN	Yes	No

Expired US Patents for RAZADYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-003	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	SOLUTION;ORAL	021224-001	Jun 22, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001
Janssen Pharms	RAZADYNE	galantamine hydrobromide	TABLET;ORAL	021169-002	Feb 28, 2001

International Patents for RAZADYNE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20000015851
Indonesia	17088
Japan	4172820
Denmark	549189
Australia	593051
Denmark	175839

Supplementary Protection Certificates for RAZADYNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236684	C300140	Netherlands		PRODUCT NAME: GALANTAMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER GALANTAMINE HYDROBROMIDE; NAT. REGISTRATION NO/DATE: RVG 29073 - RVG 29076 20030702; FIRST REGISTRATION: SE 15561 - 15565 20000225
0236684	3/2001	Austria		PRODUCT NAME: GALANTAMIN ODER SAEUREADDITIONSSALZE DAVON; NAT. REGISTRATION NO/DATE: 1-23748, 1-23749, 1-23750, 1-23751 20000822; FIRST REGISTRATION: SE 15561, 15562, 15563,15565 20000301
0236684	C00236684/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0236684	2001C/007	Belgium		PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
0236684	SPC/GB00/033	United Kingdom		PRODUCT NAME: GALANTHAMINE OR ACID ADDITION SALTS THEREOF; REGISTERED: SE 15561 20000301; SE 15562 20000301; SE 15563 20000301; SE 15565 20000301; UK PL08557/0039 20000914; UK PL08557/0040 20000914; UK PL08557/0041 20000914; UK PL08557/0042 20000914

RAZADYNE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Razadyne

Introduction to Razadyne

Razadyne, also known as Reminyl, is a reversible, competitive acetylcholinesterase inhibitor (AChEI) used in the treatment of mild to moderate Alzheimer's disease (AD). It was initially approved in 2001 under the name Reminyl and later renamed Razadyne in 2005 to avoid confusion with the diabetes medication Amaryl[1][5].

Mechanism of Action

Razadyne works by enhancing cholinergic function through the reversible inhibition of the hydrolysis of acetylcholine by cholinesterase. This mechanism increases the concentration of acetylcholine in the brain, which is beneficial for patients with Alzheimer's disease who have reduced cholinergic activity[5].

Market Performance

Peak and Decline

Razadyne reached its peak sales in 2004 with $247 million in the US, capturing a 14% market share. However, its sales declined by 10% to $224 million in the following year and were projected to decrease by another 30% in 2006. This decline was largely due to the introduction of the once-daily formulation, Razadyne ER, which was approved in December 2004[1].

Razadyne ER Impact

The introduction of Razadyne ER, developed under a co-development and licensing agreement with Shire Pharmaceuticals, marked a significant shift in the market dynamics. Despite initial modest sales of $25 million in 2005, Razadyne ER showed potential for growth, with sales expected to triple in the subsequent year. This formulation was approved in 24 countries and dispensed in 132,000 scripts in the US during its first year[1].

Competitive Landscape

Dominance of Aricept and Namenda

The Alzheimer's disease treatment market is dominated by drugs like Aricept and Namenda. These drugs are often used in combination, which has contributed to the market's growth. Physicians have learned to use these products together, enhancing their efficacy across all stages of Alzheimer's disease[1].

Generic Competition

The patent for Razadyne was invalidated in court, leading to the entry of generic versions. Mylan, along with another generics company, was granted 180-day marketing exclusivity for galantamine, the active ingredient in Razadyne. This exclusivity period, which would have started after the patent's original expiration in December 2008, allowed Mylan to boost its revenues despite Razadyne not being a blockbuster drug[3].

Financial Trajectory

Sales Figures

• 2004: Peak sales of $247 million in the US with a 14% market share[1].
• 2005: Sales declined to $224 million, a 10% decrease[1].
• 2006: Projected sales decline of at least another 30%[1].
• 2008: Sales of $102 million for the 12 months ending in June[3].

Revenue Impact of Generic Competition

The invalidation of the Razadyne patent and the subsequent marketing exclusivity for generic versions significantly impacted the financial trajectory. Mylan's access to this exclusivity period was expected to boost the company's revenue, particularly during a time when shareholder confidence was low due to other business challenges[3].

Manufacturing and Project Economics

Setting up a galantamine (Razadyne) manufacturing plant involves significant capital and operational expenditures. A detailed project report would include analyses of capital investment, operating expenses, income projections, taxation, depreciation, and liquidity analysis. The report also covers regulatory procedures, financial assistance, and necessary certifications[2].

Market Forecast and Analysis

Sales Forecast

Sales forecasts for Razadyne/Reminyl from 2012 to 2022 were provided in a market analysis report by Research and Markets. The report covered sales projections for the top eight countries, including France, Germany, Italy, Spain, the UK, Japan, China, and India. This analysis helped in understanding the competitive landscape and planning business strategies effectively[5].

Regulatory and Approval Aspects

Razadyne has undergone various regulatory approvals and has been approved in multiple countries. The once-daily formulation, Razadyne ER, was approved in 24 countries, highlighting the drug's global reach and regulatory compliance[1].

Conclusion

Razadyne, despite its initial success, faced significant challenges due to the introduction of its once-daily formulation and generic competition. The drug's market dynamics were influenced by its mechanism of action, competitive landscape, and regulatory approvals. Understanding these factors is crucial for pharmaceutical companies to navigate the complex Alzheimer's disease treatment market.

Key Takeaways

• Mechanism of Action: Razadyne enhances cholinergic function by inhibiting the hydrolysis of acetylcholine.
• Market Performance: Peak sales in 2004 followed by a decline due to the introduction of Razadyne ER and generic competition.
• Competitive Landscape: Dominated by Aricept and Namenda, with physicians often using these drugs in combination.
• Financial Trajectory: Significant impact from generic competition and marketing exclusivity.
• Manufacturing and Project Economics: Detailed analysis required for setting up a manufacturing plant.
• Market Forecast and Analysis: Sales projections available for top eight countries from 2012 to 2022.

FAQs

What is the mechanism of action of Razadyne?

Razadyne works by enhancing cholinergic function through the reversible inhibition of the hydrolysis of acetylcholine by cholinesterase[5].

Why did the sales of Razadyne decline after 2004?

The sales declined due to the introduction of the once-daily formulation, Razadyne ER, and the emergence of generic competition[1].

Which companies were granted marketing exclusivity for generic galantamine?

Mylan and another generics company were granted 180-day marketing exclusivity for galantamine after the patent invalidation[3].

In how many countries is Razadyne ER approved?

Razadyne ER is approved in 24 countries[1].

What is the significance of the combination therapy with Aricept and Namenda?

The combination therapy with Aricept and Namenda has contributed significantly to the growth of the Alzheimer's disease treatment market, as physicians often use these products together to enhance efficacy[1].

Sources

1. The Age of Alzheimer's - MM+M - Medical Marketing and Media
2. Galantamine (Razadyne) Manufacturing Plant Project Report 2024 - IMARC Group
3. Mylan to Share 180-Day Exclusivity for Razadyne with Barr - S&P Global Market Intelligence
4. Annual Report 2022 - Argenx (not directly relevant but included for completeness)
5. Research and Markets: Razadyne/Reminyl (Alzheimer's Disease) - Business Wire