REVATIO Drug Patent Profile

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

Revatio is a drug marketed by Viatris and is included in three NDAs.

The generic ingredient in REVATIO is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Revatio

A generic version of REVATIO was approved as sildenafil citrate by CHARTWELL RX on November 6^th, 2012.

Summary for REVATIO

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	65
Patent Applications:	5,769
Drug Prices:	Drug price information for REVATIO
What excipients (inactive ingredients) are in REVATIO?	REVATIO excipients list
DailyMed Link:	REVATIO at DailyMed

See drug prices for REVATIO

Recent Clinical Trials for REVATIO

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

Sponsor	Phase
The University of Texas Medical Branch, Galveston	Phase 2
Christoph P Hornik, MD MPH	Phase 2
Actelion	Phase 1

See all REVATIO clinical trials

Pharmacology for REVATIO

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for REVATIO

REVATIO is protected by zero US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	REVATIO	sildenafil citrate	FOR SUSPENSION;ORAL	203109-001	Aug 30, 2012	AB	RX	Yes	Yes
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	AB	RX	Yes	Yes
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	AP	RX	Yes	Yes
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	AB	RX	Yes	Yes

Expired US Patents for REVATIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005

International Patents for REVATIO

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0463756
Brazil	9102560
Finland	913017
Germany	69108991

Supplementary Protection Certificates for REVATIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	C990005	Netherlands		PRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622
0463756	5/1999	Austria		PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
0463756	300048	Netherlands		PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307
0463756	99C0007	Belgium		PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622

REVATIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Erectile Dysfunction Drugs, with a Focus on REVATIO

Introduction

The global market for erectile dysfunction (ED) drugs is experiencing significant growth, driven by various factors including increasing awareness, advancing healthcare infrastructure, and the rising prevalence of ED. This article will delve into the market dynamics and financial trajectory of ED drugs, with a particular focus on REVATIO, a brand of sildenafil citrate.

Global Erectile Dysfunction Drugs Market Overview

The global ED drugs market was valued at USD 3.2 billion in 2022 and is projected to reach USD 6.1 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.8% during the forecast period[1][4].

Market Drivers

Several factors are driving the growth of the ED drugs market:

• Increasing Prevalence of ED: The condition affects a significant portion of the male population, especially those between 40 and 70 years old. According to MSD Manuals, approximately half of American men in this age group are affected by ED, and this percentage increases with age[4].
• Poor Lifestyles: Factors such as obesity, diabetes, and heart disease, which are often linked to poor lifestyles, contribute to the increasing incidence of ED[4].
• COVID-19 Pandemic: The pandemic has had a positive impact on the market due to the increased risk of developing ED associated with COVID-19 infections[4].
• Generic Competition: The availability of generic versions of popular ED drugs, such as sildenafil, has increased accessibility and affordability, driving market growth[3].

Market Segmentation

By Drug Type

The market is segmented by drug type, with Viagra (sildenafil citrate) holding the largest revenue share of approximately 58%[1][4].

• REVATIO: While primarily known for treating pulmonary arterial hypertension (PAH), REVATIO is also a form of sildenafil citrate. However, its revenue contribution to the ED market is less significant compared to Viagra.

By Distribution Channel

Retail pharmacies dominate the distribution channel with a 46% revenue share, followed by hospital pharmacies and online pharmacies[1][4].

Regional Analysis

North America

North America accounted for the largest revenue share in 2022, with 51.7% of the total market. This is due to the high prevalence of ED, strong healthcare infrastructure, and the approval of new treatments in the region[1][4].

Asia Pacific

The Asia Pacific region is expected to experience rapid growth during the forecast period, driven by the introduction of new products and increasing awareness of ED treatments[1][4].

Financial Trajectory of ED Drugs

Revenue Growth

The ED drugs market is expected to grow significantly, with revenues projected to increase from USD 3.2 billion in 2022 to USD 6.1 billion by 2032. This growth is driven by increasing demand and the introduction of new products[1][4].

Pricing Dynamics

• Viagra: Typically costs between USD 70 to 75 per pill.
• Generic Sildenafil: Available at a significantly lower cost, starting from USD 8.5 or less per pill[1].

Competitive Landscape

The ED drugs market is highly competitive, with several key players:

• Pfizer: The manufacturer of Viagra and REVATIO, holds a significant market share due to the popularity of these drugs[1][4].

REVATIO in the ED Market

While REVATIO is primarily used for treating PAH, it is also a form of sildenafil citrate, which is the active ingredient in Viagra. However, its use and revenue contribution in the ED market are limited compared to Viagra.

Pricing and Availability

REVATIO, being a prescription drug, is priced differently based on its intended use. For PAH, it is generally covered by insurance, but for ED, it would be priced similarly to other sildenafil products.

Market Impact

The presence of REVATIO in the market, although not as prominent in the ED segment, contributes to the overall availability of sildenafil citrate. This can influence pricing and accessibility, especially in regions where generic versions are not widely available.

Key Takeaways

• The global ED drugs market is expected to reach USD 6.1 billion by 2032, growing at a CAGR of 6.8%.
• Viagra (sildenafil citrate) holds the largest revenue share in the market.
• Retail pharmacies dominate the distribution channel.
• North America and the Asia Pacific region are key markets, with North America holding the largest revenue share.
• The market is driven by increasing prevalence of ED, poor lifestyles, and the COVID-19 pandemic.
• Generic competition and new product introductions are significant growth factors.

FAQs

What is the projected market size of the global ED drugs market by 2032?

The global ED drugs market is expected to reach USD 6.1 billion by 2032[1][4].

What is the CAGR of the global ED drugs market from 2022 to 2032?

The market is expected to grow at a CAGR of 6.8% from 2022 to 2032[1][4].

Which drug holds the largest revenue share in the ED drugs market?

Viagra (sildenafil citrate) holds the largest revenue share, approximately 58% of the market[1][4].

What are the primary distribution channels for ED drugs?

Retail pharmacies hold the largest revenue share at 46%, followed by hospital pharmacies and online pharmacies[1][4].

How has the COVID-19 pandemic affected the ED drugs market?

The COVID-19 pandemic has positively impacted the market due to the increased risk of developing ED associated with COVID-19 infections[4].

Sources

1. Market.us: Erectile Dysfunction Drugs Market Size | CAGR of 6.8% - https://market.us/report/erectile-dysfunction-drugs-market/
2. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance - https://s28.q4cdn.com/781576035/files/doc_financials/2023/q4/Q4-2023-PFE-Earnings-Release.pdf
3. Business Research Insights: Sildenafil Market Size, Industry Trend & Analysis By 2032 - https://www.businessresearchinsights.com/market-reports/sildenafil-market-109422
4. GlobeNewswire: Erectile Dysfunction Drugs Market Value to Reach USD 6.1 bn by 2032 - https://www.globenewswire.com/news-release/2023/4/6/2642598/0/en/Erectile-Dysfunction-Drugs-Market-Value-to-Reach-USD-6-1-bn-by-2032-Market-Us-Study.html