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STENDRA Drug Patent Profile

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

Stendra is a drug marketed by Metuchen Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Stendra

A generic version of STENDRA was approved as avanafil by HETERO LABS LTD V on June 14^th, 2024.

Summary for STENDRA

International Patents:	41
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	6
Patent Applications:	1,696
Drug Prices:	Drug price information for STENDRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STENDRA
What excipients (inactive ingredients) are in STENDRA?	STENDRA excipients list
DailyMed Link:	STENDRA at DailyMed

See drug prices for STENDRA

Recent Clinical Trials for STENDRA

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

Sponsor	Phase
VIVUS, Inc.	Phase 4
VIVUS, Inc.	Phase 3

See all STENDRA clinical trials

Pharmacology for STENDRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Paragraph IV (Patent) Challenges for STENDRA

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 STENDRA

STENDRA is protected by one US patents and one FDA Regulatory Exclusivity.

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	202276-001	Apr 27, 2012	AB	RX	Yes	No			Y	Y
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	AB	RX	Yes	No
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No			Y	Y
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes
Metuchen Pharms	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes			Y	Y

Expired US Patents for STENDRA

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

EU/EMA Drug Approvals for STENDRA

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 STENDRA

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

Country	Patent Number	Title	Estimated Expiration
Australia	767558
Germany	60034239
Israel	148291	AROMATIC NITROGEN-CONTAINING 6-MEMBERED CYCLIC COMPOUNDS
Canada	2407231
Hungary	S1300045
China	1462193

Supplementary Protection Certificates for STENDRA

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
1219609	2013C/051	Belgium		PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609	92249	Luxembourg		PRODUCT NAME: AVANAFIL
1219609	1390047-7	Sweden		PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621

STENDRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for STENDRA (Avanafil)

Introduction to STENDRA

STENDRA, also known as Spedra, is a prescription medication indicated for the treatment of erectile dysfunction (ED). It contains the active ingredient avanafil, which distinguishes itself through its rapid onset of action and a profile of adverse effects that may be more tolerable for some patients compared to other ED treatments.

Market Position of STENDRA

Market Share and Growth Prospects

STENDRA, while not the market leader, is projected to experience significant growth in the erectile dysfunction drugs market. Despite Viagra (sildenafil) holding a substantial market share, STENDRA is anticipated to see rapid growth due to its unique pharmacological profile and increasing patient preference for faster-acting and more tolerable treatments[3].

Competitive Landscape

The erectile dysfunction drugs market is highly competitive, with several key players including Pfizer (Viagra), Eli Lilly (Cialis), and Bayer (Levitra). However, STENDRA's expeditious initiation of action and its enhanced adverse effect profile make it an appealing choice, allowing it to carve out a niche in the market[3].

Distribution Channels

Dominance of Retail Pharmacies

Retail pharmacies remain the dominant distribution channel for erectile dysfunction drugs, including STENDRA. However, online pharmacies have seen increased growth, particularly during the COVID-19 pandemic, which may impact the distribution dynamics in the future[4].

Financial Performance of Petros Pharmaceuticals

Net Sales and Revenue

Petros Pharmaceuticals, the company behind STENDRA, has experienced fluctuations in net sales. In the first quarter of 2022, net sales from Prescription Medicines, primarily STENDRA, declined by 52% year-over-year due to a supply shortage. However, the supply challenges were resolved in the second quarter of 2022[2].

In the more recent period, for the nine months ended September 30, 2024, Petros Pharmaceuticals reported a decrease in net sales by 29% compared to the same period in 2023. This decrease was part of a broader trend affecting the company's financial performance[5].

Gross Profit and Operating Expenses

The gross profit from Prescription Medicines, which includes STENDRA, has also seen declines. In the first quarter of 2022, gross profit from Prescription Medicines was $1.4 million, down from $2.8 million in the year-ago period. For the nine months ended September 30, 2024, the gross profit was $3.44 million, a decrease from $4.71 million in the same period of 2023[2][5].

Operating expenses have been a significant factor, with selling, general, and administrative expenses remaining consistent but research and development expenses increasing. For the nine months ended September 30, 2024, research and development expenses increased by 60% due to higher clinical development expenses related to the company’s OTC strategies for STENDRA[5].

Net Loss and Liquidity

Petros Pharmaceuticals has reported net losses, with a net loss of $(174,000) in the first quarter of 2022 and a net loss of $(5.05) million for the nine months ended September 30, 2024. The company's liquidity position is challenging, with cash totaling $3.9 million as of September 30, 2024, and an accumulated deficit of $103.9 million. This raises substantial doubt about the company's ability to continue as a going concern[2][5].

Regulatory and Development Initiatives

OTC Strategies and FDA Engagements

Petros Pharmaceuticals is actively engaged in several key portfolio development initiatives, including the development of an OTC draft label for STENDRA and regulatory filings with the FDA. These efforts aim to expand the market reach and accessibility of STENDRA, potentially improving its financial trajectory[2].

Patient Preferences and Market Trends

Growing Significance of Patient Preferences

The management of erectile dysfunction is increasingly influenced by patient preferences and experiences. STENDRA's rapid onset of action and potentially more tolerable side effect profile align with these trends, making it an attractive option for patients seeking alternative treatments to traditional ED medications[3].

Regional Analysis

Global Market Presence

The erectile dysfunction drugs market, including STENDRA, has a global presence with significant revenue shares in regions such as North America, Europe, and the Asia Pacific. North America had the highest revenue share in 2022, while the Asia Pacific region also contributed substantially to the market[4].

Key Takeaways

• Market Growth: STENDRA is projected to experience rapid growth due to its unique pharmacological profile.
• Financial Challenges: Petros Pharmaceuticals faces financial challenges, including declining net sales and significant operating expenses.
• Regulatory Initiatives: The company is engaged in OTC strategies and FDA filings to expand STENDRA's market reach.
• Patient Preferences: STENDRA's rapid onset and tolerable side effect profile align with growing patient preferences.
• Global Presence: The drug has a significant presence in various global regions.

FAQs

What is the current market share of STENDRA in the erectile dysfunction drugs market?

STENDRA does not hold the largest market share but is anticipated to experience significant growth due to its unique pharmacological profile.

What are the key factors affecting the financial performance of Petros Pharmaceuticals?

The financial performance is affected by declining net sales, significant operating expenses, and research and development costs.

What are the regulatory initiatives being undertaken by Petros Pharmaceuticals for STENDRA?

The company is developing an OTC draft label for STENDRA and engaging in regulatory filings with the FDA.

How does STENDRA differentiate itself from other erectile dysfunction treatments?

STENDRA distinguishes itself through its rapid onset of action and a potentially more tolerable side effect profile.

What is the outlook for the global erectile dysfunction drugs market, including STENDRA?

The market is expected to grow, with STENDRA projected to see rapid growth due to its unique characteristics and growing patient preferences.

Sources

1. Erectile Dysfunction Treatment Drugs Market Size, Share 2032 - SNS Insider
2. Petros Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update - GlobeNewswire
3. Erectile Dysfunction Drugs Market Size & Growth Trends, 2030 - Persistence Market Research
4. Erectile Dysfunction Drugs Market Size | CAGR of 6.8% - Market.US
5. Petros Pharmaceuticals, Inc. SEC 10-Q Report - TradingView