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Last Updated: December 23, 2024

Avanafil - Generic Drug Details


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What are the generic drug sources for avanafil and what is the scope of patent protection?

Avanafil is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V and Metuchen Pharms, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Avanafil has forty-one patent family members in twenty-five countries.

There are five drug master file entries for avanafil. Two suppliers are listed for this compound.

Summary for avanafil
Recent Clinical Trials for avanafil

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

SponsorPhase
University of AlexandriaPhase 4
Astellas Pharma US, Inc.Phase 1/Phase 2
Johns Hopkins UniversityPhase 1/Phase 2

See all avanafil clinical trials

Pharmacology for avanafil
Paragraph IV (Patent) Challenges for AVANAFIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STENDRA Tablets avanafil 50 mg, 100 mg and 200 mg 202276 1 2016-04-27

US Patents and Regulatory Information for avanafil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 AB RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Hetero Labs Ltd V AVANAFIL avanafil TABLET;ORAL 209266-002 Jun 14, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V AVANAFIL avanafil TABLET;ORAL 209266-003 Jun 14, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs Ltd V AVANAFIL avanafil TABLET;ORAL 209266-001 Jun 14, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 AB RX Yes 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

Expired US Patents for avanafil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-001 Apr 27, 2012 ⤷  Subscribe ⤷  Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-003 Apr 27, 2012 ⤷  Subscribe ⤷  Subscribe
Metuchen Pharms STENDRA avanafil TABLET;ORAL 202276-002 Apr 27, 2012 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for avanafil

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Menarini International Operations Luxembourg S.A. Spedra avanafil EMEA/H/C/002581
Treatment of erectile dysfunction in adult men.In order for Spedra to be effective, sexual stimulation is required.
Authorised no no no 2013-06-21 2013-04-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for avanafil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1219609 2013/041 Ireland ⤷  Subscribe PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609 CA 2013 00040 Denmark ⤷  Subscribe
1219609 C300618 Netherlands ⤷  Subscribe PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609 2013C/051 Belgium ⤷  Subscribe PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609 92249 Luxembourg ⤷  Subscribe PRODUCT NAME: AVANAFIL
1219609 1390047-7 Sweden ⤷  Subscribe PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Avanafil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Avanafil

Market Overview

The global avanafil market, a segment of the broader erectile dysfunction (ED) drugs market, is experiencing significant growth driven by several key factors. Avanafil, marketed under the brand name Stendra or Spedra, is a phosphodiesterase-5 inhibitor (PDE5i) used to treat erectile dysfunction.

Market Size and Growth

As of 2021, the global avanafil market was valued at approximately $3.65 billion. It is projected to grow to $6.12 billion by 2030, with a compound annual growth rate (CAGR) of 6.6% from 2022 to 2030[1].

Segmentation

By Medication Type

The market is primarily segmented by medication type, with erectile dysfunction being the dominant segment. Avanafil is specifically used for treating erectile dysfunction, which is expected to maintain its market share due to increasing prevalence of lifestyle diseases and aging populations[1].

By Product

Avanafil, along with other PDE5 inhibitors like sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra), constitutes the product segment. While sildenafil dominates the market, avanafil is gaining traction due to its fast-acting nature and fewer side effects[2].

By Route of Administration

Oral drugs are the largest segment in terms of route of administration, with avanafil being administered orally. This segment is expected to continue its dominance due to patient preference and ease of administration[1].

By Distribution Channel

The offline segment, including hospital pharmacies and retail pharmacies, currently dominates the market. However, online pharmacies are gaining popularity, especially in regions with developed healthcare infrastructure like North America[1].

By Dosage

The 50mg dosage segment is the largest, reflecting the standard dosage for avanafil. This dosage is often prescribed for its efficacy and minimal side effects[1].

Regional Analysis

North America

North America is the leading revenue generator for the avanafil market, driven by a well-developed healthcare infrastructure, a growing geriatric population, and increased technological advancements. The region is expected to continue its dominance due to the high prevalence of erectile dysfunction among men over 40[1].

Asia Pacific

The Asia Pacific region is also expected to experience significant growth due to an increasing elderly population, a thriving generic pharmaceutical industry, and the prevalence of infections related to erectile dysfunction[3].

Drivers and Restraints

Increasing Prevalence of Lifestyle Diseases

The rise in lifestyle diseases such as heart disease, diabetes, and obesity, coupled with increased consumption of alcohol and tobacco, is driving the demand for erectile dysfunction medications, including avanafil[1].

Aging Population

The aging of the male population is a significant driver, as erectile dysfunction is more prevalent among men over 40. By 2050, the number of older persons in the United States is projected to increase, further boosting the market[1].

Regulatory Approvals and Competitive Landscape

Stringent regulatory approvals and high healthcare costs pose challenges to market expansion. However, strategic initiatives such as partnerships and the pursuit of non-prescription or over-the-counter (OTC) status for avanafil are expected to enhance patient access and drive growth[1][2].

COVID-19 Impact

The COVID-19 pandemic had a favorable impact on the sales of erectile dysfunction medications, including avanafil. The pandemic led to an increase in the sales of PDE5 inhibitors, with a notable rise in tadalafil sales, which also benefited other PDE5 inhibitors like avanafil[1].

Competitive Landscape

The global avanafil market is highly competitive, with key players including Viatris Inc., Teva Pharmaceutical Industries Ltd, Century Pharmaceuticals Ltd, SK chemicals, Sun Pharmaceutical Industries Ltd, Bayer AG, Petros Pharmaceuticals, Inc., and others. These companies are engaged in various strategies such as partnerships, acquisitions, and the development of new drug formulations to maintain their market position[1].

Financial Trajectory

  • Current Market Size: The global avanafil market was valued at $3.65 billion in 2021[1].
  • Projected Market Size: Expected to reach $6.12 billion by 2030[1].
  • CAGR: 6.6% from 2022 to 2030[1].
  • Revenue Growth: Driven by increasing demand for erectile dysfunction treatments, aging populations, and expanding distribution channels[1][2][3].

Key Takeaways

  • The global avanafil market is growing at a CAGR of 6.6% from 2022 to 2030.
  • Erectile dysfunction is the dominant medication type driving the market.
  • North America leads the market due to its developed healthcare infrastructure and aging population.
  • The market is expected to benefit from increasing lifestyle diseases and the pursuit of OTC status for avanafil.
  • Key players are focusing on strategic partnerships and new drug developments to enhance market share.

FAQs

1. What is the current market size of the global avanafil market? The global avanafil market was valued at approximately $3.65 billion in 2021[1].

2. What is the projected growth rate of the global avanafil market? The market is expected to grow at a CAGR of 6.6% from 2022 to 2030[1].

3. Which region dominates the global avanafil market? North America is the leading revenue generator for the global avanafil market[1].

4. What are the main drivers of the global avanafil market? The main drivers include the increasing prevalence of lifestyle diseases, an aging population, and the expansion of distribution channels[1].

5. Which companies are key players in the global avanafil market? Key players include Viatris Inc., Teva Pharmaceutical Industries Ltd, Century Pharmaceuticals Ltd, and others[1].

Citations

  1. Extrapolate: Avanafil Market Size, Share and Industry Analysis – 2030
  2. Maximize Market Research: Erectile Dysfunction Drugs Market: Global Industry Analysis
  3. InsightAce Analytic: Erectile Dysfunction Drugs Market 2024 Analysis and Forecast to 2031
  4. Market Research Intellect: Global Avanafil Market Size | Scope | Trend and Forecast to 2031
  5. SkyQuest: Erectile Dysfunction Drugs Market Size, Trends & Forecast | 2031

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