RAZADYNE ER Drug Patent Profile

When do Razadyne Er patents expire, and what generic alternatives are available?

Razadyne Er is a drug marketed by Janssen Pharms and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Razadyne Er

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

Summary for RAZADYNE ER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	21
Patent Applications:	880
Drug Prices:	Drug price information for RAZADYNE ER
DailyMed Link:	RAZADYNE ER at DailyMed

See drug prices for RAZADYNE ER

Recent Clinical Trials for RAZADYNE ER

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

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

See all RAZADYNE ER clinical trials

Paragraph IV (Patent) Challenges for RAZADYNE ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAZADYNE ER	Extended-release Capsules	galantamine hydrobromide	16 mg and 24 mg	021615	1	2006-03-11
RAZADYNE ER	Extended-release Capsules	galantamine hydrobromide	8 mg	021615	1	2006-03-02

US Patents and Regulatory Information for RAZADYNE ER

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 ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005		DISCN	Yes	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005		DISCN	Yes	No
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005		DISCN	Yes	No

Expired US Patents for RAZADYNE ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-002	Apr 1, 2005
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005

International Patents for RAZADYNE ER

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	122411	CONTROLLED RELEASE GALANTAMINE COMPOSITION
Australia	2100600
South Korea	100195399
World Intellectual Property Organization (WIPO)	0038686
China	1331596
Brazil	9916835

Supplementary Protection Certificates for RAZADYNE ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0236684	C00236684/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
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	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
0236684	2001C/007	Belgium		PRODUCT NAME: GALANTAMINUM HYDROBROMIDUM; NAT. REGISTRATION NO/DATE: 1028 IS 94 F3 20000918; FIRST REGISTRATION: SE 15561 20000301
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

Market Dynamics and Financial Trajectory for RAZADYNE ER

Last updated: July 27, 2025

Introduction

RAZADYNE ER (Rasagiline Mesylate Extended-Release) represents a significant development within the sphere of Parkinson’s disease (PD) therapeutics. As a monoamine oxidase B (MAO-B) inhibitor, RAZADYNE ER offers an innovative treatment modality with potential to impact market share, revenue streams, and competitive positioning. This analysis explores the underlying market dynamics, regulatory landscape, competitive environment, and financial projections shaping RAZADYNE ER’s trajectory.

Market Landscape for Parkinson’s Disease Treatment

Rising Prevalence and Unmet Medical Needs

The global burden of Parkinson’s disease continues to amplify due to aging populations. The worldwide prevalence is estimated at over 10 million, with approximately 60,000 new cases diagnosed annually in the U.S. alone [1]. Existing treatment options predominantly involve symptomatic management, with no definitive cure, creating a persistent unmet need.

Therapeutic Role of Rasagiline and RAZADYNE ER

Traditionally, rasagiline, marketed as Azilect, has been prescribed in oral, immediate-release formulations. RAZADYNE ER extends the pharmacokinetic profile, enabling once-daily dosing that may improve patient adherence and quality of life. Extended-release formulations often gain favor in chronic conditions like PD due to simplified regimens.

Market Penetration and Growth Drivers

Key drivers include:

• Patient preference for simplified dosing: RAZADYNE ER’s once-daily administration aligns with consumer tendencies.
• Regulatory acceptance: Favorable FDA reviews and approvals enhance commercialization prospects.
• Collaborative indications: RAZADYNE ER’s approval for adjunctive therapy in early and advanced PD widens its potential market.

Regulatory and Commercialization Strategy

Approvals and Indications

RAZADYNE ER's approval by agencies such as the FDA is critical. Its label extensions and expanded indications influence market size and prescriber confidence. Regulatory hurdles remain, particularly in gaining approvals across different jurisdictions and for different patient populations.

Reimbursement and Pricing Dynamics

Pricing strategies consider the value proposition of extended-release formulations, patient adherence benefits, and competitive dynamics. Reimbursement policies and formulary placements significantly influence sales volume.

Commercial Partnerships

Partnerships with pharmacy chains, neurological clinics, and payers bolster distribution. Effective marketing strategies that emphasize clinical benefits over immediate-release alternatives can accelerate adoption.

Competitive Landscape

Direct Competitors

The main competitors include:

• Selegiline: Another MAO-B inhibitor with oral formulations.
• Entacapone and Tolcapone: COMT inhibitors that target different mechanistic pathways.
• Other MAO-B inhibitors: Such as safinamide (Xadago), offering distinct pharmacokinetic profiles.

Indirect Competition

Emerging therapies such as dopamine agonists, levodopa formulations, and novel neuroprotective agents influence market dynamics.

Barriers to Entry and Differentiation

Key challenges include differentiating RAZADYNE ER through clinical efficacy, safety profile, and adherence benefits. Additionally, patent protection duration and potential biosimilar developments impact competitive positioning.

Financial Trajectory and Revenue Projections

Revenue Drivers

Factors influencing revenue include:

• Market penetration rate: Adoption rate among prescribers.
• Pricing strategy: Premium pricing justified by extended-release benefits.
• Market size expansion: Geographic expansion and indication broadening.

Short- to Long-term Revenue Outlook

Forecast models project a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, driven by increasing prevalence, improved market penetration, and positive clinical outcomes [2].

Impact of Patent Expiry and Biosimilars

Patent exclusivity and data exclusivity periods influence revenue longevity. Approaching patent cliffs could lead to generic competition, impacting prices and margins.

Investment and R&D Implications

Continued investment in clinical trials and real-world evidence collection support market expansion and reinforce pipeline robustness. Strategic acquisitions or alliances could further accelerate growth.

Market Risks and Opportunities

Risks

• Regulatory delays or unfavorable decisions.
• Competitive pressure from existing and emerging therapies.
• Reimbursement challenges limiting patient access.
• Market saturation in key territories.

Opportunities

• Demonstrating superior adherence and efficacy metrics.
• Expanding indications, including early-stage PD.
• Leveraging digital health for remote adherence monitoring.
• Entering emerging markets with rising PD prevalence.

Conclusion

RAZADYNE ER’s market dynamics hinge on a confluence of clinical, regulatory, and commercial factors. Its potential to redefine treatment paradigms in Parkinson’s disease positions it favorably within a growing market. Strategic deployment, robust clinical data, and adaptability to evolving healthcare policies will be crucial for maximizing its financial trajectory.

Key Takeaways

• Market Growth: The PD market is expanding due to demographic shifts, increasing prevalence, and unmet needs.
• Product Differentiation: RAZADYNE ER’s extended-release formulation offers adherence advantages, which are central to its value proposition.
• Regulatory Strategy: Successful navigation of regulatory pathways across regions is pivotal for broad adoption.
• Competitive Edge: Differentiating through clinical efficacy, safety, and patient adherence is essential amidst robust competition.
• Financial Outlook: Expect steady revenue growth driven by expanding indications, market penetration, and geographic expansion, with potential risks from patent expirations and market saturation.

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FAQs

1. How does RAZADYNE ER differ from traditional rasagiline formulations?
RAZADYNE ER delivers rasagiline through an extended-release mechanism, enabling once-daily dosing contrasted with immediate-release formulations typically taken once or twice daily. This enhances patient adherence and convenience.

2. What is the expected timeline for RAZADYNE ER’s market penetration?
Market penetration is projected to accelerate over the next 2-3 years, contingent upon regulatory approvals, physician adoption, and reimbursement frameworks.

3. Could RAZADYNE ER face competition from emerging PD therapies?
Yes. While current competitors are mainly symptomatic treatments, novel therapies including gene therapies and neuroprotective agents could impact its market share in the long term.

4. How do regulatory approvals influence the financial outcomes of RAZADYNE ER?
Approval status determines market entry possibilities. Positive decisions expand market access, fostering revenue growth, while delays or denials restrict sales potential.

5. What are the primary factors affecting the long-term profitability of RAZADYNE ER?
Patent protection duration, market share gains, reimbursement policies, and the emergence of generics or biosimilars are the critical determinants of sustained profitability.

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References

[1] World Health Organization. Parkinson's disease Fact Sheet. 2022.
[2] Market Research Future. Parkinson’s Disease Therapeutics Market Analysis. 2023.