LEVITRA Drug Patent Profile

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

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA 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 Levitra

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

Summary for LEVITRA

International Patents:	54
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	26
Patent Applications:	4,404
Drug Prices:	Drug price information for LEVITRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEVITRA
What excipients (inactive ingredients) are in LEVITRA?	LEVITRA excipients list
DailyMed Link:	LEVITRA at DailyMed

See drug prices for LEVITRA

See drug sales revenues for LEVITRA

Recent Clinical Trials for LEVITRA

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

Sponsor	Phase
Respira Therapeutics, Inc.	Phase 1
Tritech Biopharmaceuticals Co., Ltd.	Phase 1/Phase 2
A2 Healthcare Taiwan Corporation	Phase 1/Phase 2

See all LEVITRA clinical trials

Paragraph IV (Patent) Challenges for LEVITRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 LEVITRA

LEVITRA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003		DISCN	Yes	No
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003		DISCN	Yes	No

Expired US Patents for LEVITRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003

International Patents for LEVITRA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2003249942	MEDICAMENTS CONTAINING VARDENAFIL HYDROCHLORIDE TRIHYDRATE
China	100430396
Israel	232538

LEVITRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levitra (Vardenafil)

Market Overview of Erectile Dysfunction Treatment Drugs

The erectile dysfunction (ED) treatment drugs market is experiencing significant growth, driven by various factors including increasing demand, the impact of the COVID-19 pandemic, and rising prevalence of chronic diseases.

• Market Size and Growth: The global ED treatment drugs market was valued at USD 2.69 billion in 2023 and is expected to reach USD 6.26 billion by 2033, growing at a CAGR of 8.82% from 2024 to 2033[4].
• Impact of COVID-19: The pandemic has increased the risk of ED, with an estimated prevalence of 31.8% in men with a history of COVID-19, contributing to the market's growth[1].

Levitra (Vardenafil) in the ED Market

Levitra, known by its generic name vardenafil hydrochloride, is a key player in the ED treatment market.

Product Overview

• Introduction: Levitra was first manufactured by Bayer Pharmaceuticals in 2003 as a competitor to Viagra (sildenafil citrate)[5].
• Usage: It is taken orally to treat ED symptoms similar to other common ED medications like Cialis and Viagra[5].

Market Segments and Distribution Channels

The ED treatment drugs market, including Levitra, is segmented based on several factors:

• By Product: Levitra competes with other ED medications such as Viagra, Cialis, Zydena, and Stendra[1][4].
• By Distribution Channel: The drug is available through hospital pharmacies, retail pharmacies, and online pharmacies[1][3].
• By Mode of Administration: Levitra is primarily an oral medication[1][3].

Financial Trajectory of Levitra

Revenue and Market Share

• Global Market: The overall ED treatment drugs market is expected to grow significantly, and Levitra, as a part of this market, is likely to benefit from this trend. The global ED market is projected to reach USD 6.26 billion by 2033[4].
• Regional Performance: In North America, which is the largest market for ED drugs, the market size was USD 1.43 billion in 2023 and is expected to reach USD 3.35 billion by 2033, indicating a strong regional presence for Levitra[4].

Pricing and Cost Analysis

• Cost: The cost of Levitra can vary significantly depending on factors such as dosage, quantity, insurance coverage, and pharmacy. Brand name Levitra can cost between $633 to $1,623 for ten to thirty 10 mg tablets, while generic versions cost between $390 to $450 for ten 10 mg tablets[5].
• Cost Reduction Strategies: Patients can reduce their out-of-pocket costs by using coupons, discount programs, and purchasing from pharmacies that offer better prices[5].

Manufacturing and Production Costs

For companies considering the production of vardenafil (Levitra), several economic factors come into play:

• Capital Expenditure (CapEx) and Operational Expenditure (OpEx): Setting up a vardenafil manufacturing plant involves significant capital investments, including costs for machinery, raw materials, and infrastructure. Operational expenses include ongoing costs such as utilities, manpower, and packaging[2].
• Profitability Analysis: The profitability of a vardenafil manufacturing plant can be analyzed through detailed financial projections, including income and expenditure projections, gross profit, net profit, and return on investment (ROI)[2].

Regulatory and Competitive Landscape

• Regulatory Procedures: Establishing a vardenafil manufacturing plant requires compliance with various regulatory procedures and obtaining necessary certifications. This includes financial assistance and approvals from relevant health authorities[2].
• Competitive Landscape: The ED treatment market is highly competitive, with Levitra competing against other well-established brands like Viagra and Cialis. Market strategies, including pricing, marketing, and distribution, play a crucial role in maintaining market share[1][4].

Impact of Chronic Diseases and Lifestyle Factors

• Chronic Diseases: Conditions such as diabetes and hypertension, which are prevalent globally, contribute to the incidence of ED. This increases the demand for ED treatment drugs, including Levitra[1].
• Lifestyle Factors: The adoption of sedentary lifestyles and associated stress also drive the demand for ED drugs, contributing to the market's growth[4].

Regional Analysis

The ED treatment drugs market, including Levitra, varies significantly across different regions:

• North America: This is the largest market for ED drugs, driven by high healthcare spending and awareness about ED treatments[4].
• Europe, Asia-Pacific, Latin America, and Middle East & Africa: These regions also show significant growth potential, although at varying rates due to differences in healthcare access and awareness[3][4].

Key Takeaways

• Market Growth: The ED treatment drugs market is expected to grow significantly, driven by increasing demand and the impact of chronic diseases.
• Levitra's Role: As a key player in the ED market, Levitra benefits from this growth trend.
• Financial Trajectory: The financial performance of Levitra is influenced by its pricing, distribution channels, and regional market dynamics.
• Manufacturing Costs: Setting up a vardenafil manufacturing plant involves significant capital and operational expenditures.
• Regulatory and Competitive Landscape: Compliance with regulatory procedures and competitive market strategies are crucial for maintaining market share.

FAQs

1. What is the current market size of the erectile dysfunction treatment drugs market?

   • The global ED treatment drugs market was valued at USD 2.69 billion in 2023[4].

2. How is the COVID-19 pandemic affecting the ED treatment drugs market?

   • The pandemic has increased the risk of ED, contributing to the market's growth[1].

3. What are the key distribution channels for Levitra?

   • Levitra is available through hospital pharmacies, retail pharmacies, and online pharmacies[1][3].

4. How much does Levitra typically cost?

   • The cost of Levitra can range from $633 to $1,623 for brand name and $390 to $450 for generic versions, depending on the dosage and quantity[5].

5. What are the major factors driving the growth of the ED treatment drugs market?

   • The growth is driven by increasing demand, the impact of chronic diseases, and lifestyle factors such as sedentary lifestyles and associated stress[1][4].

Sources

1. SNS Insider - Erectile Dysfunction Treatment Drugs Market Size, Share 2032
2. IMARC Group - Vardenafil (Levitra) Manufacturing Plant Project Report 2024
3. InsightAce Analytic - Erectile Dysfunction Drugs Market 2024 Analysis and Forecast to 2031
4. Precedence Research - Erectile Dysfunction Drugs Market Size to Hit USD 6.26 Bn By 2033
5. Healthline - Levitra Cost: How to Get it Cheaper