Vardenafil hydrochloride - Generic Drug Details

What are the generic sources for vardenafil hydrochloride and what is the scope of freedom to operate?

Vardenafil hydrochloride is the generic ingredient in three branded drugs marketed by Bayer Hlthcare, Alembic, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms, and is included in ten NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Vardenafil hydrochloride has one hundred and seven patent family members in forty-three countries.

There are six drug master file entries for vardenafil hydrochloride. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for vardenafil hydrochloride

International Patents:	107
US Patents:	2
Tradenames:	3
Applicants:	7
NDAs:	10
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	82
Patent Applications:	21
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vardenafil hydrochloride
What excipients (inactive ingredients) are in vardenafil hydrochloride?	vardenafil hydrochloride excipients list
DailyMed Link:	vardenafil hydrochloride at DailyMed

Recent Clinical Trials for vardenafil hydrochloride

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

Sponsor	Phase
AriBio Co., Ltd.	Phase 3
Respira Therapeutics, Inc.	Phase 1
Johns Hopkins University	Phase 1/Phase 2

See all vardenafil hydrochloride clinical trials

Generic filers with tentative approvals for VARDENAFIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET, ORALLY DISINTEGRATING;ORAL
		10MG	TABLET, ORALLY DISINTEGRATING;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for vardenafil hydrochloride

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vardenafil hydrochloride

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for VARDENAFIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STAXYN	Orally Disintegrating Tablets	vardenafil hydrochloride	10 mg	200179	1	2011-12-22
LEVITRA	Tablets	vardenafil hydrochloride	2.5 mg	021400	1	2009-09-04
LEVITRA	Tablets	vardenafil hydrochloride	5 mg and 10 mg	021400	1	2009-07-10
LEVITRA	Tablets	vardenafil hydrochloride	20 mg	021400	1	2009-03-05

US Patents and Regulatory Information for vardenafil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Crossmedika Sa	VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET;ORAL	209057-004	Oct 31, 2018	AB	RX	No	No
Crossmedika Sa	VARDENAFIL HYDROCHLORIDE	vardenafil hydrochloride	TABLET;ORAL	209057-003	Oct 31, 2018	AB	RX	No	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No	8,273,876

Expired US Patents for vardenafil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003	7,696,206
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003	8,841,446
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003	8,841,446

International Patents for vardenafil hydrochloride

Country	Patent Number	Title	Estimated Expiration
Cuba	23473	MEDICAMENTOS QUE CONTIENEN CLORHIDRATO DE VARDENAFILO TRIHIDRATO
Norway	20120203
Croatia	P20120545

Vardenafil hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vardenafil Hydrochloride

Introduction

Vardenafil hydrochloride, commonly known by the brand name Levitra, is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED). Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global market for erectile dysfunction drugs, which includes vardenafil hydrochloride, has been experiencing steady growth. In 2022, the erectile dysfunction drugs market was valued at $2.6 billion and is projected to reach $5.1 billion by 2032, growing at a CAGR of 6.5% from 2023 to 2032[3].

Segment Analysis

Type of Drug

Vardenafil hydrochloride is one of the key drugs in the ED market, alongside sildenafil (Viagra) and tadalafil (Cialis). The market segmentation by drug type indicates that PDE5 inhibitors, including vardenafil, dominate the market due to their efficacy and widespread use[3][5].

Application and End-Use

The primary application of vardenafil hydrochloride is in the treatment of erectile dysfunction. The demand for this drug is driven by the increasing prevalence of ED, particularly among the aging population and those with lifestyle-related health issues such as heart disease and diabetes[3].

Regional Analysis

North America is currently the largest market for erectile dysfunction drugs, including vardenafil hydrochloride, due to robust healthcare infrastructure and high healthcare expenditure. However, the Asia-Pacific region is expected to grow at the highest rate during the forecast period, driven by increasing awareness, growing pharmaceutical industries, and rising disposable income[3][5].

Market Drivers

Several factors drive the growth of the vardenafil hydrochloride market:

Increasing Prevalence of Erectile Dysfunction

The rise in cases of erectile dysfunction, partly due to an aging population and lifestyle factors such as smoking and sedentary lifestyles, increases the demand for ED drugs[3].

Advanced Healthcare Infrastructure

Regions with well-established healthcare infrastructure, such as North America and parts of Asia-Pacific, see higher adoption rates of ED treatments, including vardenafil hydrochloride[3].

Product Launches and Innovations

Key players in the market, such as Bayer, are continuously enhancing their product portfolios and launching new formulations, which helps in maintaining market growth[1].

Growing Awareness and Acceptance

Increased awareness about erectile dysfunction and the availability of effective treatments contribute to the market's expansion[3].

Market Restraints

Despite the growth drivers, there are several restraints that affect the market:

Side Effects and Safety Concerns

Vardenafil hydrochloride, like other PDE5 inhibitors, can have side effects such as headaches, facial flushing, and in rare cases, more severe effects like sudden loss of vision or hearing. These side effects can deter some patients from using the drug[4].

Lack of Awareness

In some regions, there is a lack of awareness and knowledge about erectile dysfunction and its treatments, which can limit market growth[3].

Regulatory and Patent Issues

The expiration of patents for some ED drugs and regulatory challenges can impact the market dynamics and profitability for pharmaceutical companies[1].

Financial Trajectory

Revenue Growth

The global drugs for erectile dysfunction market, which includes vardenafil hydrochloride, is expected to experience moderate growth. From $3.21 billion in 2022, the market is projected to reach $3.36 billion by 2027, albeit at a slower CAGR of 0.8% during this period[5].

Key Players

Companies like Bayer, Pfizer Inc., Eli Lilly and Company, and others hold significant market positions. These companies are focusing on strategy building, product portfolio enhancement, and business expansion to maintain their market share[1][3].

Competitive Analysis

The erectile dysfunction drugs market is highly competitive, with several key players. The competition is driven by the need to innovate, expand product lines, and penetrate new markets. Companies are also focusing on building strong distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies[5].

Regional Insights

• North America: Currently the largest market, driven by high healthcare expenditure and robust infrastructure.
• Asia-Pacific: Expected to grow at the highest rate due to increasing awareness, growing pharmaceutical industries, and rising disposable income.
• Middle East: Anticipated to be the fastest-growing region in the forecast period, driven by increasing use of ED drugs and public-private investments in healthcare[3][5].

Future Prospects

The future prospects for vardenafil hydrochloride are positive, driven by the increasing demand for ED treatments. However, the market will need to navigate challenges such as side effects, regulatory issues, and patent expirations.

"The global drugs for erectile dysfunction market is projected to experience moderate growth, increasing from $3.21 billion in 2022 to $3.36 billion in 2027 at a Compound Annual Growth Rate (CAGR) of 0.8%."[5]

Key Takeaways

• The global erectile dysfunction drugs market, including vardenafil hydrochloride, is expected to grow from $2.6 billion in 2022 to $5.1 billion by 2032.
• North America is the largest market, but Asia-Pacific is expected to grow at the highest rate.
• Increasing prevalence of ED, advanced healthcare infrastructure, and growing awareness drive market growth.
• Side effects, lack of awareness, and regulatory issues are key restraints.
• Key players are focusing on product innovation and market expansion.

FAQs

What is the current market size of the erectile dysfunction drugs market?

The erectile dysfunction drugs market was valued at $2.6 billion in 2022[3].

Which region is expected to grow at the highest rate in the erectile dysfunction drugs market?

The Asia-Pacific region is expected to grow at the highest rate during the forecast period[3].

What are the primary drivers of the vardenafil hydrochloride market?

The primary drivers include the increasing prevalence of erectile dysfunction, advanced healthcare infrastructure, and growing awareness about ED treatments[3].

What are some of the side effects associated with vardenafil hydrochloride?

Common side effects include headache, facial flushing, and upset stomach. Less frequent but more severe side effects include sudden loss of vision or hearing[4].

Which companies are key players in the vardenafil hydrochloride market?

Key players include Bayer, Pfizer Inc., Eli Lilly and Company, and others[1][3].

Sources

1. Cognitive Market Research - Global Vardenafil Hydrochloride Trihydrate Market Report 2024.
2. FDA - Levitra (vardenafil HCl) Label.
3. Allied Market Research - Erectile Dysfunction Drugs Market Statistics | Projection - 2032.
4. OncoLink - Vardenafil Hydrochloride (Levitra®).
5. GlobeNewswire - Global Drugs for Erectile Dysfunction Market 2023-2027.