Sildenafil citrate - Generic Drug Details

What are the generic sources for sildenafil citrate and what is the scope of freedom to operate?

Sildenafil citrate is the generic ingredient in four branded drugs marketed by Viatris, 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, Cmp Dev Llc, 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 fifty-two NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sildenafil citrate has nine patent family members in nine countries.

There are eighteen drug master file entries for sildenafil citrate. Sixty-nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for sildenafil citrate

International Patents:	9
US Patents:	4
Tradenames:	4
Applicants:	37
NDAs:	52
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	138
Patent Applications:	7,085
Drug Prices:	Drug price trends 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

Generic filers with tentative approvals for SILDENAFIL CITRATE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET; ORAL
		50MG	TABLET; ORAL
		25MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Invagen Pharms	SILDENAFIL CITRATE	sildenafil citrate	FOR SUSPENSION;ORAL	213041-001	Aug 6, 2020	AB	RX	No	No
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	AB	RX	Yes	Yes
Macleods Pharms Ltd	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	202255-001	Apr 19, 2023	AB	RX	No	No
Macleods Pharms Ltd	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	202255-003	Apr 19, 2023	AB	RX	No	No
Aurobindo Pharma Ltd	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	203963-001	Nov 18, 2015	AB	RX	No	No
Novitium Pharma	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	216383-003	Aug 29, 2023	AB	RX	No	No

Expired US Patents for sildenafil citrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998	6,469,012*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998	6,469,012*PED
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	5,250,534*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	6,469,012*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	5,250,534*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998	5,250,534*PED

International Patents for sildenafil citrate

Country	Patent Number	Title	Estimated Expiration
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
World Intellectual Property Organization (WIPO)	2019130052
China	111683683	PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Japan	2021509114	ＰＤＥ Ｖ阻害剤のための液体経口処方物
Brazil	112020012986	formulações orais líquidas para inibidores de pde v

Supplementary Protection Certificates for sildenafil citrate

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	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

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)"