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. 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 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:	81
Clinical Trials:	21
Patent Applications:	4,497
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 Medical Center	Phase 1/Phase 2
Vanderbilt University	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	021615-003	Apr 1, 2005	4,663,318
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-001	Apr 1, 2005	4,663,318
Janssen Pharms	RAZADYNE ER	galantamine hydrobromide	CAPSULE, EXTENDED RELEASE;ORAL	021615-003	Apr 1, 2005	7,160,559

International Patents for RAZADYNE ER

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100437105
Hungary	0104778
Denmark	549189

Supplementary Protection Certificates for RAZADYNE ER

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

RAZADYNE ER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RAZADYNE ER

Introduction to RAZADYNE ER

RAZADYNE ER, or galantamine hydrobromide extended-release capsules, is a medication used in the treatment of Alzheimer's disease. It was approved in December 2004 and is manufactured under a co-development and licensing agreement between Johnson & Johnson’s Ortho-McNeil Neurologics and Shire Pharmaceuticals[1].

Market Performance and Sales

Initial Sales and Market Share

RAZADYNE ER entered the market with modest initial sales but showed promising growth. In 2005, it posted $25 million in US sales, with 132,000 prescriptions dispensed. The sales were expected to triple in the following year, indicating a strong start[1].

Decline of Branded Sales

However, the sales of RAZADYNE ER, like its immediate-release counterpart RAZADYNE, were impacted by the emergence of generic alternatives. The patent for RAZADYNE expired in 2015, leading to the entry of several generic versions into the market. This resulted in a significant decline in the sales of the branded product[4].

Market Share and Competition

Dominance of Other Alzheimer's Treatments

The Alzheimer's disease treatment market is dominated by other drugs such as Aricept and Namenda. These drugs are often used in combination, which has contributed to their market dominance. Aricept, in particular, has a large lead due to its efficacy and better tolerance compared to other cholinesterase inhibitors like RAZADYNE[1].

Competition from Generic Versions

The launch of generic versions of RAZADYNE ER by companies like Teva Pharmaceutical Industries Ltd. and Cipla Limited has further eroded the market share of the branded product. These generic versions offer a cost-effective alternative, which is attractive to both patients and healthcare providers[4].

Financial Trajectory

Revenue Trends

The revenue from RAZADYNE ER has seen a decline over the years due to the competition from generic versions. Despite its initial growth, the sales have not sustained at the expected levels. The global galantamine hydrobromide market, which includes RAZADYNE ER, was valued at USD 2.8 billion in 2021 but is expected to grow at a moderate CAGR of 5.6% from 2021 to 2033[4].

Impact of Patent Expiration

The expiration of the patent for RAZADYNE in 2015 marked a significant turning point in the financial trajectory of the drug. The entry of generic alternatives led to a substantial reduction in the sales of the branded product, affecting the revenue of the pharmaceutical companies involved[4].

Geographical Market Dynamics

North America and Europe

North America has been a dominant market for RAZADYNE ER, driven by the high prevalence of Alzheimer's disease and well-established healthcare infrastructure. However, the market share in these regions has been impacted by the availability of generic alternatives[4].

Asia Pacific Region

The Asia Pacific region is expected to witness the fastest growth during the forecast period. Countries like China, Japan, and India are key markets due to their large population base, increasing prevalence of Alzheimer's disease, and growing investments in healthcare infrastructure[4].

Market Opportunities and Challenges

Extended-Release Formulations and Combination Therapies

The development of extended-release formulations and combination therapies presents significant opportunities for market players. RAZADYNE ER itself is an example of an extended-release formulation that allows for once-daily dosing, improving patient compliance[4].

Side Effects and Lack of Awareness

However, the market growth is restrained by the side effects associated with galantamine hydrobromide, such as nausea, vomiting, diarrhea, and weight loss. Additionally, the lack of awareness about Alzheimer's disease in certain regions, particularly in developing countries, affects the market growth[4].

Recent Developments and Acquisitions

Generic Launches

Recent years have seen the launch of generic versions of RAZADYNE ER by several pharmaceutical companies. For instance, Teva Pharmaceutical Industries Ltd. launched a generic version of RAZADYNE ER in the United States in 2021[4].

Acquisitions and Expansions

Companies like Novartis AG have expanded their neuroscience portfolios through acquisitions, such as the acquisition of Cadent Therapeutics in 2020. These moves indicate a continued interest in the Alzheimer's disease treatment market despite the challenges faced by branded products like RAZADYNE ER[4].

Key Takeaways

• RAZADYNE ER, despite its initial promise, has seen a decline in sales due to the emergence of generic alternatives.
• The drug faces strong competition from other Alzheimer's treatments like Aricept and Namenda.
• The global galantamine hydrobromide market is expected to grow at a moderate CAGR, driven by the Asia Pacific region.
• Extended-release formulations and combination therapies offer opportunities for market growth.
• Side effects and lack of awareness about Alzheimer's disease are significant challenges.

FAQs

1. What is RAZADYNE ER used for?

RAZADYNE ER is used in the treatment of Alzheimer's disease. It is an extended-release formulation of galantamine hydrobromide.

2. Why did the sales of RAZADYNE ER decline?

The sales of RAZADYNE ER declined due to the expiration of its patent and the subsequent entry of generic alternatives into the market.

3. Which regions are expected to drive the growth of the galantamine hydrobromide market?

The Asia Pacific region, particularly countries like China, Japan, and India, is expected to drive the growth of the galantamine hydrobromide market.

4. What are the side effects associated with RAZADYNE ER?

Common side effects of RAZADYNE ER include nausea, vomiting, diarrhea, and weight loss.

5. How does RAZADYNE ER compare to other Alzheimer's treatments?

RAZADYNE ER faces strong competition from other Alzheimer's treatments like Aricept and Namenda, which are often used in combination and have a larger market share due to their efficacy and better tolerance.

Cited Sources:

1. The Age of Alzheimer's - MM+M - Medical Marketing and Media
2. ALPHA COGNITION INC. - 2023-Q1MDA
3. RAZADYNE (galantamine hydrobromide) - accessdata.fda.gov
4. Galantamine Hydrobromide Lycoremine Market Size, Share, Growth ... - Data Horizon Research
5. ALPHA COGNITION INC. - 2023-YE-MDA