Endo Begins Shipment of Generic Kuvan® Tablets and Powder for Oral Solution (sapropterin dihydrochloride)

Rhea-AI Summary

Endo International plc (NASDAQ: ENDP) has announced that its subsidiary, Par Pharmaceutical, has commenced shipping sapropterin dihydrochloride tablets and powder for oral solution after receiving FDA approval for its Abbreviated New Drug Application. These products are generic versions of Kuvan® and are the first generics available in the market. The sales of Kuvan® were approximately $489 million for the 12 months ending June 30, 2020. This launch expands Endo's product offerings, providing a more cost-effective alternative for patients.

Positive

• Launch of generic sapropterin dihydrochloride expands product portfolio into the cofactor therapeutic class.
• The product is a cost-effective alternative to the existing Kuvan® offering, potentially attracting more patients.

Negative

• None.

DUBLIN, Oct. 1, 2020 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) today announced that its subsidiary, Par Pharmaceutical, Inc. (Par), has begun shipping sapropterin dihydrochloride tablets, 100 mg, and powder for oral solution, 100 mg and 500 mg, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application. Par's sapropterin dihydrochloride tablets and powder for oral solution are the generic version of Kuvan® tablets and powder for oral solution and are the first, and currently the only, generic versions available. 

"We are excited to launch sapropterin tablets and powder for oral solution, expanding our product portfolio into the cofactor therapeutic class. This new product offering will allow patients a more cost effective alternative than what is currently available in the market," said Domenic Ciarico, Executive Vice President & Chief Commercial Officer Sterile and Generics at Endo.

According to BioMarin, Kuvan® tablet and powder for oral solution sales were approximately $489 million for the 12 months ended June 30, 2020.

Kuvan® is a registered trademark of BioMarin Pharmaceutical Inc.

About Endo International plc
Endo International plc (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Endo has global headquarters in Dublin, Ireland and U.S. headquarters in Malvern, Pennsylvania. Learn more at www.endo.com or connect with us on LinkedIn.

About Par Pharmaceutical
Par Pharmaceutical develops, manufactures and markets safe, innovative and cost-effective generic pharmaceutical and branded injectable products that help improve patient quality of life. Par, among the top leaders in the U.S. generics industry, possesses a portfolio that includes sterile injectables, alternative dosage forms and other differentiated products. Par is advancing a robust development pipeline of potential products. Par Pharmaceutical is an Endo company. Learn more at www.parpharm.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including the statements by Mr. Ciarico, within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the Securities and Exchange Commission ("SEC") and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval ("SEDAR), and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.

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SOURCE Endo International plc

FAQ

What new product has Endo announced on October 1, 2020?

Endo announced the launch of sapropterin dihydrochloride tablets and powder for oral solution.

Why is the launch of sapropterin dihydrochloride significant for Endo?

It is the first generic version of Kuvan®, potentially increasing market share and offering cost savings for patients.

How much did Kuvan® generate in sales for the 12 months ending June 30, 2020?

Kuvan® sales were approximately $489 million.

What is the stock symbol for Endo International?

The stock symbol for Endo International is ENDP.