![]() With a sterile manufacturing facility located in Rochester, Michigan, Par Sterile Products possesses an unparalleled reputation for high-quality products and an impeccable record of regulatory compliance. Par Sterile Products develops, manufactures and markets a broad portfolio of branded and generic aseptic injectable products. Our focus is on therapeutically equivalent ANDA-based products, and others on a case-by-case basis. Par Pharmaceutical specializes in modified-released oral solid dosage forms as well as non-oral dosage forms, such as nasal sprays, inhalers, patches and other alternative drug delivery platforms. We offer high-quality, cost-effective products with the highest level of customer service. Asset forfeiture is a powerful tool for the government, and one law enforcement agencies particularly prefer because the money is earmarked to further fund their investigative efforts.Par Pharmaceutical, a wholly owned Endo business, is a highly focused generic pharmaceutical company dedicated to delivering quality medicines to patients in need through excellence in innovation, development, manufacturing, and commercialization. As part of the criminal plea, the parties agreed to forfeit the $10 million wire transfer, plus pay an additional $10 million monetary fine. The government argued that the money constituted proceeds from a violation of the FDC Act, and therefore was subject to asset forfeiture under 18 U.S.C. It is unclear from the publicly available pleadings how the government traced the wire transfer, but suffice it to say that money transfers of this magnitude do not go unnoticed when a company is in the crosshairs of a criminal investigation. ![]() As part of the resolution, the parties agreed to settle an in rem action the government had brought against a $10 million wire transfer intended for Endo Pharmaceuticals. The government used asset forfeiture techniques to buttress the criminal penalty. The DPA will not be final until it is accepted by the court. is a publicly traded company based in the Philadelphia, Pennsylvania area, dedicated to the niche of pain management. In the DPA, the company admitted to certain criminal conduct, and agreed to pay a criminal fine and to impose enhanced compliance measures (many of the compliance provisions appear to overlap with the requirements of the Corporate Integrity Agreement). Attorney’s Offices can be complicated, but we have seen improved cooperation between multiple offices in recent cases.Įndo managed to escape a corporate criminal charge by entering into a deferred prosecution agreement (“DPA”) with the government. Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it will relocate its corporate headquarters to a new facility based in Malvern, Pa. Attorney’s Office in Philadelphia, and the criminal investigation handled by the Northern District of New York. McHugh received a Bachelor of Science degree from Pennsylvania State University and her masters of business administration degree from St. Attorney’s Offices bifurcated the matter, with the civil investigation managed by the U.S. The company’s global settlement included a civil payment of $171.9 million, a criminal fine of $20.8 million, and a Corporate Integrity Agreement governing the company’s ongoing practices. The government alleged ( here and here) that Endo marketed Lidoderm for general, non-PHN related pain indications, including lower back pain, diabetic neuropathy, and carpal tunnel syndrome. ![]() 2000: Endo becomes a public company by acquiring Algos Pharmaceutical Corporation. Sales grew another 43 percent in 2000 to 187.4 million. ![]() The drug is Lidoderm, a prescription drug patch that FDA approved to treat pain associated with post-herpetic neuralgia, or PHN. 2000 In October 2000, The Purdue Frederick Company sued Endo, alleging that Endo had infringed on patents relating to Ox圜ontin by developing a generic form of the drug. The defendants are Endo Health Solutions, and its subsidiary, Endo Pharmaceuticals Inc., based in Malvern, Pennsylvania. But some aspects of this recent settlement, coupled with other recent cases, might indicate noteworthy trends in how these cases are being resolved. Yes, this post relates to yet another off-label settlement between a pharmaceutical company and the federal government. ![]()
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