You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

VARDENAFIL HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Vardenafil Hydrochloride is a drug marketed by Alembic, Macleods Pharms Ltd, Crossmedika Sa, Stevens J, Teva Pharms, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in VARDENAFIL HYDROCHLORIDE is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vardenafil Hydrochloride

A generic version of VARDENAFIL HYDROCHLORIDE was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for VARDENAFIL HYDROCHLORIDE?
  • What are the global sales for VARDENAFIL HYDROCHLORIDE?
  • What is Average Wholesale Price for VARDENAFIL HYDROCHLORIDE?
Drug patent expirations by year for VARDENAFIL HYDROCHLORIDE
Recent Clinical Trials for VARDENAFIL HYDROCHLORIDE

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

SponsorPhase
AriBio Co., Ltd.Phase 3
Respira Therapeutics, Inc.Phase 1
Astellas Pharma US, Inc.Phase 1/Phase 2

See all VARDENAFIL HYDROCHLORIDE clinical trials

Pharmacology for VARDENAFIL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for VARDENAFIL HYDROCHLORIDE
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
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 208324-001 Nov 16, 2018 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 091347-001 May 3, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 208960-003 Oct 31, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Crossmedika Sa VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 209057-001 Oct 31, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alembic VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 214031-002 Aug 4, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Macleods Pharms Ltd VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 204632-002 Oct 22, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms VARDENAFIL HYDROCHLORIDE vardenafil hydrochloride TABLET;ORAL 091347-003 May 3, 2012 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.