SILDENAFIL CITRATE Drug Patent Profile

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

Sildenafil Citrate is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Invagen Pharms, Lupin Ltd, MSN, Novitium Pharma, Somerset Theraps Llc, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Appco, Cadila Pharms Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc. and is included in forty-seven NDAs.

The generic ingredient in SILDENAFIL CITRATE 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 Sildenafil Citrate

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

Summary for SILDENAFIL CITRATE

US Patents:	0
Applicants:	35
NDAs:	47
Finished Product Suppliers / Packagers:	66
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	138
Patent Applications:	5,769
Drug Prices:	Drug price information for SILDENAFIL CITRATE
Drug Sales Revenues:	Drug sales revenues for SILDENAFIL CITRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SILDENAFIL CITRATE
What excipients (inactive ingredients) are in SILDENAFIL CITRATE?	SILDENAFIL CITRATE excipients list
DailyMed Link:	SILDENAFIL CITRATE at DailyMed

See drug prices for SILDENAFIL CITRATE

See drug sales revenues for SILDENAFIL CITRATE

Recent Clinical Trials for SILDENAFIL CITRATE

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

Sponsor	Phase
Batterjee Medical College	Phase 4
University of Pennsylvania	Phase 2
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso	Phase 4

See all SILDENAFIL CITRATE clinical trials

Pharmacology for SILDENAFIL CITRATE

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for SILDENAFIL CITRATE

Phosphodiesterase 5 Inhibitors

Urological Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for SILDENAFIL CITRATE

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

Paragraph IV (Patent) Challenges for SILDENAFIL CITRATE

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 SILDENAFIL CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	091448-001	Jun 11, 2018	AB	RX	No	No
Hetero Labs Ltd V	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	203623-001	Nov 26, 2014	AB	RX	No	No
Aurobindo Pharma Ltd	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	203962-002	Jun 11, 2018	AB	RX	No	No
Mylan	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	201171-001	Mar 25, 2019	AB	RX	No	No

SILDENAFIL CITRATE Market Analysis and Financial Projection Experimental

Sildenafil Citrate Market Dynamics and Financial Trajectory

Market Overview

Sildenafil citrate, widely known by the brand name Viagra, is a phosphodiesterase type 5 (PDE5) inhibitor used primarily to treat erectile dysfunction (ED). The market for sildenafil citrate is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

• The sildenafil citrate market was valued at USD 1.58 billion in 2023 and is expected to reach USD 3.13 billion by 2036, growing at a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024-2036[1].
• Another projection indicates that the market could reach USD 2.3 billion by 2030, with a CAGR of 5.5% from 2024 to 2030[4].

Regional Analysis

• The market is segmented into several major regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is predicted to hold the largest revenue share by 2036, driven by the high prevalence of ED cases in the region[1].
• The Asia Pacific region is expected to grow at the highest rate due to an aging population and increasing awareness of ED in countries such as India, China, and Japan[1].

Key Market Segments

• The sildenafil market is segmented based on type (50mg tablets, 100mg tablets, and others), application (hospital pharmacies, retail pharmacies, and online pharmacies), and distribution channels (retail pharmacies, hospital pharmacies, online pharmacies, and others)[3][4].

Driving Factors

Increasing Awareness and Acceptance

• One of the primary drivers of the sildenafil citrate market is the increasing awareness and acceptance of ED treatments. Historically, men faced significant social stigma surrounding ED, but recent years have seen a marked shift in societal attitudes, making it more acceptable for men to discuss their issues and seek medical intervention[4].

Generic Competition

• The introduction of generic alternatives has significantly impacted the market. Generic competition has made sildenafil citrate more affordable, enhancing market accessibility and driving sales[3].

Advancements in Drug Formulations

• Innovations in drug formulations, including new delivery methods such as oral jellies, oral sprays, and topical gels, are enhancing patient adherence and accessibility. These advancements are contributing to the market's growth by providing more convenient and effective treatment options[4].

Marketing and Educational Campaigns

• Pharmaceutical companies are implementing targeted marketing strategies and educational campaigns to destigmatize ED and promote awareness through digital platforms. These efforts have positively influenced public perception, encouraging more individuals to pursue treatment[4].

Economic Impact

• Studies have shown that sildenafil citrate is cost-effective compared to other PDE5 inhibitors. Cost analyses suggest that sildenafil would lower direct costs to healthcare systems, and patients have exhibited a willingness to pay (WTP) for sildenafil in the U.S. and U.K.[2].

Cost-Effectiveness

• Cost-effectiveness models have indicated favorable profiles for sildenafil compared to other active-treatment options, particularly in sub-groups such as those with spinal cord injuries, diabetes, or hypertension[2].

Distribution Channels

• The market is supported by various distribution channels, including retail pharmacies, hospital pharmacies, and online pharmacies. The rise of online pharmacies has made it easier for patients to access sildenafil citrate, contributing to the market's growth[3][4].

Geographical Dominance

• North America dominates the sildenafil citrate market due to the high prevalence of ED, advanced healthcare infrastructure, and the presence of key pharmaceutical companies. The region's robust pipeline of innovative formulations and regulatory support for pharmaceutical products also contribute to its dominance[4].

Therapeutic Applications Beyond ED

• Ongoing research into the therapeutic applications of sildenafil citrate beyond ED, such as treating pulmonary arterial hypertension, highlights its versatility and potential for further market expansion[4].

Key Takeaways

• The sildenafil citrate market is expected to grow significantly, driven by increasing awareness and acceptance of ED treatments, generic competition, and advancements in drug formulations.
• North America is predicted to hold the largest revenue share, while the Asia Pacific region is expected to grow at the highest rate.
• The market is supported by various distribution channels, including online pharmacies, which enhance accessibility.
• Sildenafil citrate is cost-effective compared to other PDE5 inhibitors and has favorable cost-effectiveness profiles in certain patient sub-groups.

FAQs

What is the projected market size of sildenafil citrate by 2036?

The sildenafil citrate market is expected to reach USD 3.13 billion by 2036[1].

What is the CAGR of the sildenafil citrate market from 2024 to 2036?

The market is expected to grow at a CAGR of 5.4% from 2024 to 2036[1].

Which region is expected to hold the largest revenue share in the sildenafil citrate market?

North America is predicted to hold the largest revenue share by 2036[1].

What are the key driving factors of the sildenafil citrate market?

The key driving factors include increasing awareness and acceptance of ED treatments, generic competition, and advancements in drug formulations[3][4].

Is sildenafil citrate cost-effective compared to other PDE5 inhibitors?

Yes, cost analyses suggest that sildenafil citrate would lower direct costs compared to other PDE5 inhibitors, and patients have exhibited a willingness to pay for sildenafil[2].

Sources

1. Research Nester, "Sildenafil Citrate Market Size & Share - Forecast Report 2036"
2. PubMed, "A systematic review assessing the economic impact of sildenafil"
3. Business Research Insights, "Sildenafil Market Size, Industry Trend & Analysis By 2032"
4. IndustryARC, "Sildenafil Citrate Market - Forecast(2024 - 2030)"