Endo International

About Endo

Endo is a Dublin, Ireland based company with U.S. headquarters in Malvern, Pennsylvania. The company started as a generic division of DuPont Merck but was split off and has become a global influence through a series of acquisitions and mergers.Endo currently functions as an umbrella organization with multiple business units including Endo Pharmaceuticals, Par Pharmaceutical, Endo Aesthetics and Paladin Labs. Therapeutic focus areas of Endo include endocrinology, orthopedics, and urology.

The company was asked to withdraw its extended-release oxycodone product, Opana from the market in 2017 and has faced numerous drug injury and opioid pain medication lawsuits. Some of these lawsuits have been settled but others remain in court systems.

Endo History

Endo originally began in 1920 as Intravenous Products of America, Inc. but adopted the name “Endo” in 1935. It was acquired by E.I. du Pont de Nemours and Company to be incorporated into DuPont’s greater business. The Endo division was reestablished as Endo Laboratories in 1994, serving as DuPont Merck’s generic section.

In 1997, three DuPont executives acquired certain products through a management buyout and purchased the remaining generic division Endo Laboratories, LLC. This included Percocet, Percodan and 10 other licensed products, along with the generics the company had been manufacturing. In 1998, another big product, Lidoderm was licensed from Hind Healthcare with would mark the beginning of more than two decades of acquisition, mergers, and spinoffs. The company became publicly traded as Endo Pharmaceuticals (ENDP) in 2000 after the merger with Algos Pharmaceutical.

Acquisitions included:

• 2000 – Algos Pharmaceutical Corporation
• 2006 – RxKinetix Inc.
• 2009 – Indevus Pharmaceuticals
• 2010 – HealthTronics Inc.
• 2010 – Penwest Pharmaceuticals
• 2010 – Qualitest Pharmaceuticals
• 2011 – American Medical Systems Inc.
• 2014 – Boca Pharmacal
• 2014 – Paladin Labs
• 2014 – Grupo Farmaceutico Somar (SOMAR)
• 2014 – DAVA Pharmaceuticals
• 2015 – Auxilium Pharmaceuticals
• 2015 – Litha Healthcare
• 2015 – Par Pharmaceuticals

In 2012, Endo changed the corporate name to Endo Health Solutions. In 2014, Endo divested HealthTronics and established global headquarters of Endo International plc in Dublin.

In 2015, Endo completed divestiture of Advanced Medical Supplies (AMS) Men’s Health to Boston Scientific and wound down Astora (formerly AMS) women’s health unit. In 2017, Endo divested Litha Healthcare Group and Grupo Farmaceutico SOMAR.

In 2022, with a crash of Endo stock below $1 a share, Endo International Plc filed for Chapter 11 bankruptcy protection.

Endo Products

Endo International, plc oversees the operations of four business units including:

• Endo Pharmaceuticals – Brand name pharmaceutical development, manufacturing, and marketing in endocrinology, pain management, and oncology
• Par Pharmaceutical – Generic pharmaceutical and branded injectable products, including authorized generic agreements with a number of pharmaceutical companies
• Endo Aesthetics – Developed the first FDA-approved injectable treatment for cellulite in the buttocks
• Paladin Labs – Specialty pharmaceutical development and licensing for Canada

Endo Pharmaceuticals manufactures popular pain-killer Percocet, along with topical pain medications Lidoderm and Voltaren gel products. The company also formerly manufactured Opana ER, an extended-release oxycodone product which was withdrawn from the market upon FDA request in 2017.

The company also manufactures several testosterone products including:

• Aveed (testosterone undecanoate) Injection
• Fortesta (testosterone) Gel
• Striant (testosterone) Mucoadhesive for buccal administration
• Testim (testosterone) Gel
• Testopel (testosterone) Pellets for injection

Several testosterone gel manufacturers, including Endo, have faced thousands of testosterone replacement therapy lawsuits.

Though Endo divested most AMS products and discontinued manufacturing others, Endo may still be responsible for injuries caused by urological devices or products manufactured by AMS including transvaginal mesh and bladder slings.

Endo International, AMS, and Transvaginal Mesh

Transvaginal mesh products manufactured by multiple companies including Endo/AMS for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) may have caused injury to thousands of women and the company still faces many lawsuits.

Transvaginal mesh was first introduced in 1996 for the treatment of SUI in women. It was modeled after surgical mesh that was in use to repair other tissue damage such as hernia and was designed to be safer than traditional surgical repair methods as the mesh was implanted through the vagina or “transvaginally”. The product was later approved to treat POP but the first product was recalled after only three years due to safety concerns.

Since the first products were introduced, hundreds more have come on the market and have been shown to cause serious side effects that are permanently damaging and may become life-threatening such as:

• Vaginal erosion – the mesh erodes the vaginal wall and may become implanted
• Organ perforation – mesh erosion may persist all the way through the vaginal wall or may perforate other organs
• Revision surgery – corrective surgery may be required to address injury caused by the mesh or to correct new or untreated SUI or POP

American Medical Systems produced a number of transvaginal mesh products before acquisition by Endo International.

AMS continues to produce transvaginal mesh and some of these may have caused significant injury including:

• Apogee
• BioArc products
• Elevate
• In-Fast Ultra
• IntePro Y-graft
• Perigee
• MiniArc products
• Monarc Subfascial Hammock
• RetroArc Retropubic Sling
• SPARC Sling

Thousands of patients have been injured by transvaginal mesh, including several deaths. The FDA stated in a safety release that transvaginal mesh does not appear to be safer than traditional surgery and may pose a significant risk to patients who receive the devices.

Endo and its former subsidiary, AMS agreed to pay more than $2.8 billion to settle more than 48,000 AMS transvaginal mesh lawsuits in several cases in 2013 through 2016. In 2017, the company further agreed to settle most of the estimated 22,000 remaining lawsuits for about $775 million.

Endo Pharmaceuticals and Testosterone Replacement

Testosterone replacement therapy is approved to treat low testosterone levels in men with hypogonadism. Multiple pharmaceutical manufacturers have aggressively promoted their topical testosterone replacement products for “Low-T” and are used by as many as 3 percent of men over the age of 40, though many of those men have never been tested for low testosterone levels.

Testosterone replacement therapy has been shown to contribute to a number of serious medical conditions such as:

• Heart Attack
• Stroke
• Blood Clot Formation
• Death

Endo has manufactured a number of testosterone replacement products including:

• Aveed (testosterone undecanoate) Injection
• Fortesta (testosterone) Gel
• Striant (testosterone) Mucoadhesive for buccal administration
• Testim (testosterone) Gel
• Testopel (testosterone) Pellets for injection

Hundreds of lawsuits have been filed against testosterone replacement manufacturers including hundreds of lawsuits against Endo, for injuries caused by Testim Gel. In 2018, Endo agreed to settle about 1,300 testosterone lawsuits for $200 million from a fund set aside the previous year.

Endo Opioid Lawsuits

Endo International has faced a number of lawsuits filed by governmental agencies in multiple states for its involvement in the opioid crisis. In August 2022, Endo reached a settlement with 36 states to settle allegations that the company falsely marketed its long-acting oxycodone product, Opana ER, as safe from abuse and addiction. Endo’s involvement is part of a much larger opioid epidemic involving multiple pharmaceutical companies.

Endo has agreed to pay $450 million over 10 years to support treatment and prevention programs addressing opioid addiction. Prior to that agreement, Endo also agreed to pay $50 million to New York, $63 million to Texas, $65 million to Florida, and $26 million to West Virginia to settle similar charges.

In August 2022, Endo began the process of reorganization of debt under Chapter 11 bankruptcy protection.