STAXYN Drug Patent Profile

When do Staxyn patents expire, and what generic alternatives are available?

Staxyn is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-three patent family members in thirty-eight countries.

The generic ingredient in STAXYN 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 Staxyn

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

Summary for STAXYN

International Patents:	53
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	71
Patent Applications:	4
Drug Prices:	Drug price information for STAXYN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STAXYN
What excipients (inactive ingredients) are in STAXYN?	STAXYN excipients list
DailyMed Link:	STAXYN at DailyMed

See drug prices for STAXYN

See drug sales revenues for STAXYN

Paragraph IV (Patent) Challenges for STAXYN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STAXYN	Orally Disintegrating Tablets	vardenafil hydrochloride	10 mg	200179	1	2011-12-22

US Patents and Regulatory Information for STAXYN

STAXYN 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	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010		DISCN	Yes	No	8,613,950		Y

Expired US Patents for STAXYN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010	6,362,178
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010	7,696,206

International Patents for STAXYN

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

Country	Patent Number	Title	Estimated Expiration
Argentina	111572	FORMAS FARMACÉUTICAS QUE CONTIENEN VARDENAFILO
China	100430396
Norway	20120203
Uruguay	25246	IMIDAZOTRIAZINONAS SUSTITUIDAS POR 2-FENILO
Sweden	0001745
Japan	3356428
Israel	135462	PHOSPHODIESTERASE INHIBITING 1 - ETHOXY - 2 - [5-METHYL- 4[3H] OXO - 7 - PROPYLIMIDAZO [5,1 - f] [1,2,4]TRIAZIN - 2 - YL] BENZENE- 4 - SULFONAMIDE DERIVATIVES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

STAXYN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Staxyn (Vardenafil)

Introduction to Staxyn

Staxyn, also known by its generic name vardenafil, is a popular medication used to treat erectile dysfunction (ED). It is part of the phosphodiesterase type 5 (PDE5) inhibitor class, which also includes Viagra (sildenafil) and Cialis (tadalafil).

Market Size and Growth

The global erectile dysfunction drugs market, which includes Staxyn, is experiencing significant growth. As of 2022, the market was valued at approximately USD 3.2 billion and is projected to reach USD 6.1 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.8%[1].

Market Segments and Distribution

By Drug Type

Staxyn is one of the key products in the ED drugs market, although it does not dominate the market share as significantly as Viagra. The market is segmented into various drugs, with Staxyn (vardenafil) being one of the notable players alongside Viagra, Cialis, Stendra/Spedra, Zydena, and Vitaros[1][4].

By Distribution Channel

The distribution channels for Staxyn include hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies hold the largest revenue share at 46%, followed by hospital pharmacies with a 35% market share. Online pharmacies have seen increased growth, particularly during the COVID-19 pandemic, due to the rise in online medicine purchases[1].

Regional Analysis

The global ED drugs market is geographically segmented, with North America holding the highest revenue share in 2022 at 51.7%. The Asia Pacific region also has a significant share, accounting for 26.3% of the market in 2022. These regions are crucial for the sales and distribution of Staxyn[1].

Drivers of Market Growth

Several factors drive the growth of the ED drugs market, including Staxyn:

Increasing Geriatric Population

The rising geriatric population is a significant driver, as ED is more common among older men. This demographic shift contributes to the increasing demand for ED treatments[1][4].

Patient Awareness and Education

Growing awareness and education about ED among individuals worldwide are boosting the market. Public initiatives, especially in developing regions, are helping to increase knowledge and acceptance of these medications[1][4].

Lifestyle Disorders

The rise in lifestyle disorders such as obesity, cardiovascular diseases, diabetes, and high blood pressure also contributes to the market growth. These conditions are often associated with an increased risk of ED[4].

Restraints and Challenges

Despite the growth, there are several challenges that affect the market for Staxyn and other ED drugs:

Low Awareness and Side Effects

In low- and mid-income countries, there is a lack of awareness about ED and its treatments. Additionally, side effects such as nausea, headaches, dizziness, and diarrhea can deter patients from using these medications[1].

Generic Competition

The availability of generic versions of ED drugs, including generic vardenafil, can impact the sales of branded products like Staxyn. Generic sildenafil, for example, can be purchased for as low as USD 8.5 per pill, which is significantly cheaper than branded options[1].

Financial Trajectory

Revenue and Market Share

While specific financial data for Staxyn alone is not readily available, it is part of a larger market that is expected to grow substantially. The ED drugs market, dominated by Viagra with a 58% revenue share, includes Staxyn as a significant player. However, its market share is smaller compared to Viagra and Cialis[1].

Pricing

The pricing of Staxyn can vary but is generally lower than that of Viagra. Branded Staxyn typically costs less than Viagra, which can range from USD 70 to 75 per pill. Generic versions of vardenafil are even more affordable, contributing to the overall market growth[1].

Strategic Initiatives and Collaborations

Companies involved in the ED drugs market, including those manufacturing Staxyn, often engage in strategic initiatives to enhance their market presence. For instance, collaborations and supply agreements, such as the one between Pfizer and Digital Men's Clinic Roman for generic Viagra, can also impact the market dynamics for other ED drugs like Staxyn[4].

Future Outlook

The future outlook for Staxyn and the broader ED drugs market is positive, driven by increasing patient awareness, an ageing population, and the rise in lifestyle disorders. Despite challenges such as low awareness in certain regions and the availability of generic alternatives, the market is expected to continue growing.

Key Takeaways

• Market Growth: The global ED drugs market is expected to grow at a CAGR of 6.8% from 2022 to 2032.
• Regional Dominance: North America holds the highest revenue share, followed by the Asia Pacific region.
• Distribution Channels: Retail pharmacies dominate the distribution, but online pharmacies are growing.
• Drivers: Increasing geriatric population, patient awareness, and lifestyle disorders drive market growth.
• Challenges: Low awareness, side effects, and generic competition are significant restraints.

FAQs

Q: What is the projected market size for the ED drugs market by 2032? A: The global ED drugs market is expected to reach approximately USD 6.1 billion by 2032[1].

Q: Which region has the highest revenue share in the ED drugs market? A: North America holds the highest revenue share in the ED drugs market, accounting for 51.7% in 2022[1].

Q: How does the pricing of Staxyn compare to other ED drugs? A: Staxyn is generally priced lower than Viagra but higher than generic versions of ED drugs[1].

Q: What are the main drivers of the ED drugs market growth? A: The main drivers include the increasing geriatric population, growing patient awareness, and the rise in lifestyle disorders[1][4].

Q: What challenges does the ED drugs market face? A: The market faces challenges such as low awareness in certain regions, side effects of the medications, and competition from generic alternatives[1].