Qualitest was an American pharmaceutical company that specialized in generic drugs and over-the-counter products. The company had a long history, tracing its origins back to 1935. However, in recent years there had been questions around whether Qualitest was still operating or if it had been discontinued. This article will examine the history of Qualitest, look at when and why it was discontinued, and discuss the company’s legacy.
History of Qualitest
Qualitest was founded in 1935 by Sam and Emanuel Katz in Queens, New York initially as a flavoring company. The Katz brothers focused on creating syrups, elixirs, and other products aimed at pharmacies.
In the 1940s, Qualitest began expanding into manufacturing full pharmaceutical products. They specialized in liquid generic drugs like cough syrups and analgesics. Throughout the 40s and 50s, the company grew steadily, establishing manufacturing facilities in Huntsville, Alabama and Las Piedras, Puerto Rico.
The 1960s and 70s were a time of major growth and expansion for Qualitest. In 1961, they opened their first modern manufacturing plant in Huntsville dedicated to solid dose products like tablets and capsules. They also began accelerating their production of generic drugs during this time period to take advantage of new regulations allowing the approval of generics through the Abbreviated New Drug Application (ANDA) process.
Qualitest was one of the early companies to jump heavily into generic drug manufacturing. Throughout the 70s and 80s they expanded their portfolio of generics and grew to become one of the largest generic drug makers in the country.
In the 1990s and 2000s, Qualitest continued its focus on generics as well as over-the-counter medicines. They had manufacturing and R&D facilities throughout the United States as well as Puerto Rico. The company was still owned and managed by the Katz family during this period.
Acquisition by Endo Pharmaceuticals
In 2010, Qualitest was acquired by the specialty pharmaceutical company Endo Pharmaceuticals for $1.2 billion. Endo was interested in Qualitest primarily for its generic pain management medications.
Under Endo, Qualitest operated largely independently but with access to greater resources for growth and expansion. Endo helped expand Qualitest’s generic portfolio and boosted R&D spending.
However, Endo itself began facing financial difficulties due to lawsuits, debt issues, and other factors. In 2015, the company announced it would be laying off workers and restructuring its generics business. The Qualitest unit was hit hard by these cutbacks aimed at reducing costs.
Discontinuation of Qualitest
In September 2019, Endo Pharmaceuticals announced that it would be discontinuing the Qualitest brand and closing or selling its manufacturing facilities. This decision was made largely due to the major financial pressures on Endo. The company determined that shutting down Qualitest would reduce operating costs and allow them to focus on their core brand-name drugs instead of generics.
The Qualitest facilities in Huntsville, AL and Charlotte, NC were shut down between 2019 and 2020. Equipment and operations were consolidated into Endo’s other generic subsidiaries like Par Pharmaceutical. The Qualitest name was retired after over 80 years in business.
While Endo claimed that the discontinuation of Qualitest would allow them to run a “leaner, more efficient” generics business, it also represented the loss of a well-known and historic pharmaceutical brand. At its peak, Qualitest employed over 3,000 people and operated major manufacturing sites. The closure of these facilities resulted in significant job losses.
Qualitest’s legacy
Though the Qualitest brand name has been retired, the company leaves behind an important legacy, especially in the generics industry. Some highlights of Qualitest’s history and accomplishments include:
– One of the first companies to focus heavily on generic drugs starting in the 1960s and 70s
– Major expansion of generics portfolio to over 200 medications at its peak
– High-volume manufacturing of both solid and liquid generic medications
– Long track record of producing affordable generic alternatives to brand medications
– Employment provided to thousands of workers over the decades at its multiple manufacturing sites
– Leadership in gaining early FDA approvals for generic drugs
– Investment in expanding generics research and bringing generic products to market
– Focus on efficient and high-quality manufacturing of generic medications
So while Qualitest may no longer exist as a company, its impact helped shape the generics drug industry and regulatory processes that enabled access to affordable medicine. The push for generics that Qualitest contributed to starting in the mid-20th century helped pave the way for the rise of generics we see today.
Reasons for Qualitest’s decline
Qualitest remained an important player in pharmaceuticals for decades after its founding. However, there are several reasons the company began to decline in the late 2010s, ultimately leading to its discontinuation:
– **Increasing competition in generics** – The generic drug industry became much more crowded and competitive thanks to changes that made approval easier. This squeezed profit margins.
– **Consolidation of generics companies** – Larger pharma companies acquired generics makers like Qualitest, leading to redundancies.
– **Regulatory issues** – Stricter FDA regulation increased compliance costs for generics makers.
– **Loss of exclusivities** – As patents on blockbuster drugs expired, Qualitest lost lucrative exclusivity periods on some generics.
– **Pricing pressures** – Wholesalers and retailers began pushing back against price hikes for generic drugs.
– **Parent company struggles** – Endo Pharmaceuticals, Qualitest’s parent, faced lawsuits, debt woes, and restructuring needs.
– **Shifting focus to specialty drugs** – As revenue from generics fell, Endo sought to move away from this segment.
Ultimately, it became difficult for Qualitest to remain profitable as a standalone generics maker amidst these industry changes. Its parent company’s financial problems and shift away from generics spelled the end of Qualitest as a distinct entity.
Conclusion
In 2019, after over 80 years in business, Qualitest discontinued operations and closed its facilities. The factors behind this included a difficult industry environment for generic drug makers as well as financial problems for parent company Endo Pharmaceuticals. Though Qualitest is no longer around, it retains an important legacy for its role in helping advance the generics drug industry through both manufacturing and research. The company served as an influential pioneer in generic pharmaceuticals for decades, contributing to lower cost medicines that millions benefited from over the years. While the Qualitest name has faded, its impact remains.
