AVANAFIL - Generic Drug Details

What are the generic drug sources for avanafil and what is the scope of freedom to operate?

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

International Patents:	41
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	24
Patent Applications:	2,798
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANAFIL
What excipients (inactive ingredients) are in AVANAFIL?	AVANAFIL excipients list
DailyMed Link:	AVANAFIL at DailyMed

Recent Clinical Trials for AVANAFIL

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

Sponsor	Phase
University of Alexandria	Phase 4
Astellas Pharma US, Inc.	Phase 1/Phase 2
Johns Hopkins University	Phase 1/Phase 2

See all AVANAFIL clinical trials

Pharmacology for AVANAFIL

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AVANAFIL

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

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	6,656,935		Y	Y
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-002	Jun 14, 2024	AB	RX	No	No
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-003	Jun 14, 2024	AB	RX	No	No

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	7,501,409
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	7,501,409
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	7,501,409

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

International Patents for AVANAFIL

Country	Patent Number	Title	Estimated Expiration
Australia	767558
Germany	60034239
Israel	148291	AROMATIC NITROGEN-CONTAINING 6-MEMBERED CYCLIC COMPOUNDS

Supplementary Protection Certificates for AVANAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1219609	2013/041	Ireland		PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609	CA 2013 00040	Denmark
1219609	C300618	Netherlands		PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621

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