Market Share | Aspargo Laboratories Inc.

Market Strategy

We seek to quickly capture market share with this novel formulation of sildenafil citrate. We intend to aggressively market Sildenafil Oral Spray and build awareness among key opinion leaders and healthcare professionals, enabling us to build brand loyalty and to continually expand our market share. As the market matures, we intend to maintain our market position by leveraging our brand equity and name recognition in the market. We aim to win market dominance through product innovation and product line extensions. Our branding will enable us to develop trust and a deep emotional connection with patients.

Market Opportunity

Global ED drug market valued at $4.82B in 2017.
It is expected to reach $7.1B by 2024

Projected Market Share

Projected market share of sildenafil prescriptions estimated at 2% and growing to 10% over 5 years is based on comparable product analogs and KOL feedback.

Projected Revenue in $U.S. Millions

Suggested unit (30mL bottle) Wholesale Acquisition Cost (WAC) of $60 is based on the following:

Reflects 2019 online (ro) price of $80 per 40 sildenafil 20mg tablets (30mL spray = 38 tablets) discounted for wholesaler profit, resulting in WAC of ~ $60 per unit
Disregards price increases for inflation or decreases for generic pricing downward pressure

Pathway To Approval

Aspargo is seeking to obtain FDA authorization to market the product in the United States pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This regulation provides that new routes of administration for an approved drug qualify for an expedited form of approval.

Benefits of a 505(b)(2) pathway include the opportunity to:

Approval under Section 505(b)(2) provides the potential for three years of FDA market exclusivity in addition to existing patent protection.
Avoid the need to duplicate studies to demonstrate what is already known about sildenafil in the treatment of ED; Generally, obtain FDA approval based on a single low-risk trial in a small number of patients; Obtain three years of FDA market exclusivity in addition to the market protection provided by Aspargo’s licensed U.S. formulation patent.
Aspargo is seeking to obtain FDA approval in the second half of 2021 and commercially launch the product in the first quarter of early 2022.
Aspargo’s sildenafil oral spray is protected by US patent No. 10,016,428 B2 (granted: July 10, 2018) – Pharmaceutical Composition of Sildenafil Citrate in the Form of a Suspension for Oral Use – and by trade secrets and manufacturing know-how necessary to manufacture the oral spray formulation and to ensure drug stability.