VIAGRA Drug Patent Profile

Which patents cover Viagra, and when can generic versions of Viagra launch?

Viagra is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in VIAGRA 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 Viagra

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

Summary for VIAGRA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	160
Patent Applications:	5,378
Drug Prices:	Drug price information for VIAGRA
Drug Sales Revenues:	Drug sales revenues for VIAGRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIAGRA
What excipients (inactive ingredients) are in VIAGRA?	VIAGRA excipients list
DailyMed Link:	VIAGRA at DailyMed

See drug prices for VIAGRA

See drug sales revenues for VIAGRA

Recent Clinical Trials for VIAGRA

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

Sponsor	Phase
University Hospital, Rouen	Phase 3
Pia Wintermark	Phase 2
Al-Azhar University	Phase 2

See all VIAGRA clinical trials

Pharmacology for VIAGRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Paragraph IV (Patent) Challenges for VIAGRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIAGRA	Tablets	sildenafil citrate	25 mg and 50 mg	020895	1	2004-11-19
VIAGRA	Tablets	sildenafil citrate	100 mg	020895	1	2004-10-25

US Patents and Regulatory Information for VIAGRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998	AB	RX	Yes	No
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	AB	RX	Yes	No
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998	AB	RX	Yes	Yes

Expired US Patents for VIAGRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998

International Patents for VIAGRA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0463756
Norway	325558
Japan	H11286444	MEDICINE FOR TREATING FEMALE GENITAL INSUFFICIENCY
Denmark	0702555
Germany	69408981

Supplementary Protection Certificates for VIAGRA

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
0463756	SPC/GB99/004	United Kingdom		PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914

VIAGRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Viagra

Introduction

Viagra, known generically as sildenafil citrate, has been a revolutionary drug in the treatment of erectile dysfunction (ED) since its introduction in the late 1990s. Here, we delve into the market dynamics and financial trajectory of this iconic medication.

Market Size and Growth

The erectile dysfunction drugs market, led by Viagra, has shown significant growth over the years. As of 2022, the ED drugs market was valued at USD 3.2 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.8% from 2022 to 2032, reaching USD 6.1 billion by 2032[1][3][4].

Market Share and Dominance

Viagra holds a substantial market share in the ED drugs market. In 2023, it accounted for approximately 31.97% of the market share, making it the leading drug in this segment[4]. Its brand recognition, robust efficacy, and prolonged market presence have established it as a preferred choice among consumers seeking ED treatment[3].

Distribution Channels

The distribution of Viagra is predominantly through retail pharmacies, which hold the largest revenue share at 46%. Hospital pharmacies also play a significant role, holding a 35% market share. Online pharmacies are increasingly becoming a viable distribution channel, especially with the rise of telehealth services[1].

Regional Performance

North America, particularly the United States, has the highest revenue share in the ED drugs market, accounting for 51.7% in 2022. The Asia Pacific region also shows significant growth, with a revenue share of 26.3% in 2022[1].

Competitive Landscape

Despite losing its market exclusivity in several regions, including Europe in 2013 and the US in 2020, Viagra continues to perform well against generic competition. The entry of generic sildenafil citrate from companies like Teva has increased competition, but Viagra's brand loyalty and strong sales in international markets have helped maintain its market position[5].

Generic Competition

Generic versions of sildenafil citrate, such as those offered by Teva and Pfizer's own authorized generic, have been available since 2017. These generics are significantly cheaper, starting from USD 8.5 or less per pill, compared to the branded version which costs between USD 70 to 75 per pill[1][5].

Strategic Partnerships

To expand its reach, Pfizer has partnered with digital health clinics like Roman to offer generic Viagra. This strategic alliance aims to facilitate the expansion of Pfizer's pharmaceuticals sector and make ED treatment more accessible through telehealth services[3].

Financial Performance

Historically, Viagra was one of Pfizer's blockbuster drugs, generating over $1 billion in sales every year for 17 years and reaching a peak of $2.1 billion in 2012. Despite the erosion of sales due to generic competition, Viagra still contributes significantly to Pfizer's revenue. In 2020, despite losing market exclusivity, Viagra saw a 29% increase in global sales between Q2 and Q3, driven by strong sales in China and other international markets[5].

Current Financials

After the spin-off of Pfizer's Upjohn division, which includes Viagra, and its merger with Mylan NV to form Viatris, the financial performance of Viagra is now reported under Viatris. Viatris reported total revenues of $15.4 billion in 2023, with solid performance across its broader portfolio, including its generics segment which includes sildenafil[2].

Future Outlook

The ED drugs market, led by Viagra, is expected to continue growing. New developments, such as the FDA approval of topical ED gels for over-the-counter sales, are expanding the treatment options and making them more accessible. This is likely to drive further growth in the market, despite the presence of generic competitors[4].

Key Takeaways

• Market Size and Growth: The ED drugs market, led by Viagra, is expected to grow from USD 3.2 billion in 2022 to USD 6.1 billion by 2032 at a CAGR of 6.8%.
• Market Share: Viagra holds a significant market share, around 31.97% in 2023.
• Distribution Channels: Retail pharmacies and hospital pharmacies are the major distribution channels.
• Regional Performance: North America and the Asia Pacific region are key markets.
• Competitive Landscape: Despite generic competition, Viagra maintains its market position through brand loyalty and strategic partnerships.
• Financial Performance: Historically a blockbuster drug, Viagra continues to contribute significantly to Viatris's revenue.

FAQs

What is the current market size of the erectile dysfunction drugs market?

The erectile dysfunction drugs market was valued at USD 3.2 billion in 2022[1].

What is the projected growth rate of the ED drugs market?

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

What is the market share of Viagra in the ED drugs market?

Viagra holds approximately 31.97% of the market share in the ED drugs market as of 2023[4].

How does the cost of generic sildenafil compare to branded Viagra?

Generic sildenafil starts from USD 8.5 or less per pill, while branded Viagra costs between USD 70 to 75 per pill[1].

What are the major distribution channels for Viagra?

Retail pharmacies hold the largest revenue share at 46%, followed by hospital pharmacies at 35%[1].

What is the regional distribution of the ED drugs market?

North America has the highest revenue share at 51.7%, followed by the Asia Pacific region at 26.3% in 2022[1].

Sources

1. Market.us: Erectile Dysfunction Drugs Market Size | CAGR of 6.8% [https://market.us/report/erectile-dysfunction-drugs-market/]
2. Viatris Newsroom: Viatris Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides 2024 Financial Guidance [https://newsroom.viatris.com/2024-02-28-Viatris-Reports-Fourth-Quarter-and-Full-Year-2023-Financial-Results-and-Provides-2024-Financial-Guidance]
3. Maximize Market Research: Erectile Dysfunction Drugs Market: Global Industry Analysis [https://www.maximizemarketresearch.com/market-report/global-erectile-dysfunction-drugs-market/25288/]
4. SNS Insider: Erectile Dysfunction Treatment Drugs Market Size, Share 2032 [https://www.snsinsider.com/reports/Erectile-Dysfunction-Treatment-Drugs-Market-4327]
5. Pharmaceutical Technology: Viagra outdoes competition with Q3 sales [https://www.pharmaceutical-technology.com/analyst-comment/viagra-competition-q3-sales/]