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Last Updated: December 22, 2024

VAZCULEP Drug Patent Profile


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

Vazculep is a drug marketed by Exela Pharma and is included in one NDA.

The generic ingredient in VAZCULEP is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.

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Summary for VAZCULEP
Drug patent expirations by year for VAZCULEP
Drug Prices for VAZCULEP

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Pharmacology for VAZCULEP

US Patents and Regulatory Information for VAZCULEP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exela Pharma VAZCULEP phenylephrine hydrochloride SOLUTION;INTRAVENOUS 204300-001 Jun 27, 2014 AP1 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Exela Pharma VAZCULEP phenylephrine hydrochloride SOLUTION;INTRAVENOUS 204300-002 Jun 27, 2014 AP1 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Exela Pharma VAZCULEP phenylephrine hydrochloride SOLUTION;INTRAVENOUS 204300-003 Jun 27, 2014 AP1 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

VAZCULEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vazculep

Introduction to Vazculep

Vazculep, developed by Avadel Pharmaceuticals, is an FDA-approved phenylephrine hydrochloride injection. It is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Here, we will delve into the market dynamics and financial trajectory of this key product.

Market Approval and Launch

Vazculep received FDA approval on June 27, 2014. Following approval, Avadel began shipping the product to wholesalers in October 2014. The product is available in 1mL single-use vials, and 5mL and 10mL pharmacy bulk package vials, making it the only FDA-approved version of phenylephrine hydrochloride available in all three vial sizes[1].

Market Share and Competition

As of the first quarter of 2017, Vazculep held approximately 40% of the 1mL market volume. For the 5mL and 10mL vial sizes, Vazculep has been the sole source since its approval in 2014. This dominance in the larger vial sizes has contributed significantly to its market share and revenue stability[4].

Revenue Performance

In the third quarter of 2023, Avadel reported a revenue of $6.2 million from its injectable products, with Vazculep being a major contributor to this revenue stream. The annual sales of Vazculep are projected to reach approximately $25 million in the near term, based on market demand[2].

Market Growth and Stability

The demand for Vazculep remains stable due to its consistent usage in hospital settings and among healthcare professionals. The average annual growth rate for Vazculep is projected to be around 2-4%, reflecting a mature product with steady demand[2].

Profit Margins

Vazculep, along with other legacy medications, generates significant cash flow for Avadel. The profit margins for Vazculep are considerably high, averaging around 70%. This high profitability contributes heavily to the overall cash position of the company[2].

Distribution Partnerships

Avadel has formed strategic partnerships to enhance the distribution of its products, including Vazculep. For instance, the company has an agreement with Fresenius Kabi to distribute its FDA-approved injectable drugs, leveraging Fresenius's extensive distribution network to enhance market penetration and access[2].

Competitive Landscape

The market for phenylephrine hydrochloride injections is competitive, with West-Ward Pharmaceuticals Corp. commercializing the 1mL single-dose vial as an approved product in the U.S. However, Vazculep's unique availability in all three vial sizes and its FDA approval have helped it maintain a significant market share[1].

Financial Impact on Avadel

The revenue generated from Vazculep is crucial for Avadel's financial health. In 2016, the company recognized total revenues of $39,796 for Vazculep, which, although modest, contributes to the overall revenue stability. The consistent revenue from Vazculep and other established products enables Avadel to sustain operations, invest in R&D for new product development, and maintain profitability[1][2].

Future Outlook

Given the stable demand and high profit margins, Vazculep is expected to continue as a significant revenue generator for Avadel. The company's strategy to leverage its existing product portfolio, including Vazculep, through strategic partnerships and continued innovation in drug delivery technologies, positions it well for sustained growth in the pharmaceutical market[2].

Key Takeaways

  • Market Dominance: Vazculep holds a significant market share, particularly in the 5mL and 10mL vial sizes.
  • Revenue Stability: Annual sales are projected to reach $25 million, contributing to Avadel's overall revenue stability.
  • High Profit Margins: Vazculep has high profit margins, averaging around 70%.
  • Strategic Partnerships: Distribution agreements, such as with Fresenius Kabi, enhance market access.
  • Competitive Advantage: Unique availability in all three vial sizes differentiates Vazculep from competitors.

FAQs

What is Vazculep used for?

Vazculep is an FDA-approved phenylephrine hydrochloride injection used for the treatment of clinically important hypotension occurring in the setting of anesthesia.

When was Vazculep approved by the FDA?

Vazculep was approved by the FDA on June 27, 2014.

What are the available vial sizes for Vazculep?

Vazculep is available in 1mL single-use vials, and 5mL and 10mL pharmacy bulk package vials.

How does Vazculep contribute to Avadel's revenue?

Vazculep is a significant contributor to Avadel's revenue from injectable products, with annual sales projected to reach approximately $25 million.

What is the profit margin for Vazculep?

The profit margin for Vazculep averages around 70%, contributing heavily to Avadel's overall cash position.

Cited Sources

  1. Avadel Pharmaceuticals PLC - Annual Reports. Annual Reports, 2017.
  2. Avadel Pharmaceuticals plc (AVDL) BCG Matrix Analysis. dcf.fm.
  3. Avadel Pharmaceuticals PLC - Investor Relations. investors.avadel.com.
  4. Avadel Pharmaceuticals PLC - Market Dynamics. investors.avadel.com.
  5. Avadel Pharmaceuticals PLC - Financial Statements. investors.avadel.com.

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