Indivior, Inc. manufactures and distributes pharmaceutical products. The company offers opioid medication under the brand name Suboxone and sublingual tablets under the brand name Subutex. Indivior, Inc. was formerly known as Reckitt Benckiser Pharmaceuticals, Inc. The company was incorporated in 1997 and is based in Richmond, Virginia. Indivior, Inc. operates as a subsidiary of Indivior PLC.
The Fairfax Building
10710 Midlothian Turnpike
Richmond, VA 23235
Founded in 1997
Indivior Inc. Submits New Drug Application to U.S. FDA for RBP-7000 Risperidone Monthly Depot for Treatment of Schizophrenia
Oct 2 17
Indivior PLC announced that its U.S. subsidiary, Indivior Inc. successfully submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on September 28, 2017 to seek marketing approval for RBP-7000, Indivior's investigational, once-monthly injectable risperidone in the ATRIGEL® delivery system for the treatment of schizophrenia. This NDA submission includes the results from the pivotal Phase 3 study assessing the efficacy and safety of RBP-7000 and an open-label, long-term safety study. In the pivotal randomized, double-blind, placebo-controlled study (RB-US-09-0010), RBP-7000 demonstrated statistically clinical improvement compared to placebo based on changes in mean Positive and Negative Syndrome Scale (PANSS) total and Clinical Global Impression-Severity of Illness (CGI-S) scores at 8 weeks.
Attorney General Bruce R. Beemer and 35 Other Attorneys General File Antitrust Lawsuit against Reckitt Benckiser Pharmaceuticals and Indivior
Sep 23 16
Reckitt Benckiser Pharmaceuticals and Indivior are accused of conspiring with MonoSol Rx to switch Suboxone from a tablet version to a film (that dissolves in the mouth) in order to prevent or delay generic alternatives and maintain monopoly profits. The companies are accused of violating state and federal antitrust laws. According to the lawsuit, when Reckitt introduced Suboxone in 2002 (in tablet form), it had exclusivity protection that lasted for seven years, meaning no generic tablet version could enter the market during that time. Before that period ended, however, Reckitt worked with MonoSol to create a new version of Suboxone -- a dissolvable film, similar in size to a breath strip. Over time, Reckitt allegedly converted the market away from the tablet to the film through marketing, price adjustments and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the Suboxone tablet from the United States market. The Attorneys General allege this conduct was illegal "product hopping," where a company makes modest changes to its product to extend patent protections so other companies can't enter the market and offer cheaper generic alternatives. According to the suit, the Suboxone film provided no real benefit over the tablet and Reckitt continued to sell the tablets in other countries even after removing them from the U.S. market. Reckitt also allegedly expressed unfounded safety concerns about the tablet version and intentionally delayed FDA approval of generic versions of Suboxone. As a result, the Attorneys General allege that consumers and purchasers have paid artificially high monopoly prices since late 2009, when generic alternatives of Suboxone tablets might otherwise have become available. The lawsuit, filed in the U.S. District Court for the Eastern Division of Pennsylvania, accuses the companies of violating the federal Sherman Act and state antitrust laws, including the Unfair Trade Practices and Consumer Protection Law and common law. Counts include monopolization and illegal restraint of trade. In the suit, the Attorneys General ask the court to stop the companies from engaging in anticompetitive conduct, to restore competition and to order appropriate relief for consumers and the states, plus costs and fees. Other states and territories joining the lawsuit are Alabama, Alaska, Arkansas, California, Colorado, District of Columbia, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington and Wisconsin. The lawsuit was filed on behalf of the Commonwealth by Chief Deputy Attorney General Tracy Wertz, Senior Deputy Attorney General Joseph S. Betsko and Deputy Attorney General Aaron Schwartz, all of the Office of Attorney General's Antitrust Section. The section is tasked with protecting the free enterprise system by detecting anti-competitive practices and taking legal action to stop them.