Provigil definition

Provigil means the commercial formulation of modafinil developed, manufactured and, as of the Effective Date, sold by Cephalon pursuant to FDA approval of Cephalon’s NDA 20-717.
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Provigil means modafinil formulations of various strengths marketed under the brand-name Provigil® and/or its generic equivalent modafinil.
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Examples of Provigil in a sentence

  • This net loss decrease is sharply less as a percentage of revenues as it is reflected in our decrease of .03 per share from .03 per share in December 31, 2007 from and -.06 per share in December 31, 2006.

  • Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study.

  • The drug Provigil, prescribed for sleep disorders and multiple sclerosis-related fatigue, offers a case study: Experts expected a generic version of Provigil to go on the market in late 2005, but brand-name manufacturer Cephalon paid more than $200 million to four different generic drug manufacturers, who kept their generics off the market until 2012.2 In the meantime, many patients had to pay up to $1,200 each month for the drug, or manage without it.

  • However, as a result of studying Provigil’s effects on children, Cephalon also received an additional six months of pediatric exclusivity on Provigil, extending Cephalon’s exclusivity period through April 6, 2015.

  • Id.B. Factual History Cephalon was issued U.S. Patent No. 5,618,845 (“the ‘845 patent”) in April 1997, covering specific formulations of modafinil, the active pharmaceutical ingredient (“API”) in Provigil.

  • Cephalon CEO Frank Baldino as quoted on the Provigil pay for delay deals in the Philadelphia Business Journal, Hurdles ahead for Cephalon, Mar 20, 2006, available at http://www.bizjournals.com/philadelphia/stories/2006/03/20/story1.html.

  • All of the settlement agreements included a provision where Cephalon granted the Generic Defendants a license to market their generic modafinil products on a “date certain”—the later of October 6, 2011, or, if Provigil obtained a pediatric extension of the RE ‘516 patent, April 6, 2012.

  • Plaintiffs and all of the other Class members paid prices for modafinil that were substantially greater than the prices that they would have paid absent the illegal conduct alleged herein, because: (1) Class members were deprived of the opportunity to purchase lower-priced generic modafinil instead of expensive brand name Provigil; and/or (2) the price of branded Provigil was artificially inflated by the illegal conduct.

  • As the CEO of Cephalon, the drug company that makes Provigil, reportedly said about the deal that kept generic Provigil off the market, “That’s $4 billion in sales that no one expected.”5 methoDology:Our list of the Top Twenty Pay-for-Delay Drugs details 20 drugs impacted by one or more known pay-for-delay deals which include a payment by the brand-name drug company in exchange for an agreement by the generic drug maker to delay bringing a generic to market.

  • In 1997, Cephalon was issued U.S. Patent No. 5,618,845, covering specific formulations of modafinil, the active pharmaceutical ingredient (“API”) in Provigil.

Related to Provigil

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Collaborative pharmacy practice agreement means a written and signed

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Medical malpractice insurance means insurance against legal liability incident to the practice and provision of a medical service other than the practice and provision of a dental service.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Technical Services Agreement means the Technical Services Agreement between Sabine Pass Liquefaction, LLC and Contractor, dated May 3, 2013 and any amendments thereto.

  • Technical safeguards means the technology and the policy and procedures for its use that 27 protect electronic PHI and control access to it.

  • Medical Specialist means any medical practitioner who is vocationally registered by the Medical Council under the Health Practitioners Competence Assurance Act 2003 in one of the approved branches of medicine and who is employed in either that branch of medicine or in a similar capacity with minimal oversight.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.

  • GTCs means these AVEVA General Terms and Conditions, which includes those terms and conditions set forth in the main body of the GTCs, and all of the various exhibits, addenda, and other documents incorporated into the GTCs.

  • Technical Services means all services that are necessary to carry out individual, scattered site activities including but not limited to: (1) conducting initial inspections, (2) work write-up or project specification development, (3) cost estimate preparation, (4) construction supervision associated with activities that do not require an architect or engineer, (5) lead hazard reduction or lead abatement need determination and oversight, (6) lead hazard reduction or abatement carrying costs, (7) temporary relocation coordination, (8) financing costs such as security agreement preparation and recording or filing fees, (9) processing of individual applications for assistance, (10) income eligibility determination and verification, (11) value determination (new construction) or after rehabilitation value determination (existing structures), and (12) project-specific environmental clearance processes.

  • Best Management Practices (BMPs means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the state. BMPs also include treatment requirements, operating procedures, and practices to control site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Business association means a nonpublic corporation, joint stock company, investment company, business trust, partnership, or association for business purposes of 2 or more individuals, whether or not for profit, including a banking organization, financial organization, insurance company, or utility.

  • Professional Services Agreement means the agreement attached hereto as Exhibit C and all written statements of work signed by Licensee and related thereto.

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Vigilance Officer means an officer appointed to receive protected disclosures from Whistle Blower, maintaining records thereof, placing the same before the Audit Committee for its disposal and informing the Whistle Blower the result thereof.

  • New Jersey Stormwater Best Management Practices (BMP) Manual or “BMP Manual” means the manual maintained by the Department providing, in part, design specifications, removal rates, calculation methods, and soil testing procedures approved by the Department as being capable of contributing to the achievement of the stormwater management standards specified in this chapter. The BMP Manual is periodically amended by the Department as necessary to provide design specifications on additional best management practices and new information on already included practices reflecting the best available current information regarding the particular practice and the Department’s determination as to the ability of that best management practice to contribute to compliance with the standards contained in this chapter. Alternative stormwater management measures, removal rates, or calculation methods may be utilized, subject to any limitations specified in this chapter, provided the design engineer demonstrates to the municipality, in accordance with Section IV.F. of this ordinance and N.J.A.C. 7:8-5.2(g), that the proposed measure and its design will contribute to achievement of the design and performance standards established by this chapter.

  • Legal Services means services of a legal or financial nature and includes any part of such services, and for the avoidance of doubt, includes (without limitation):-

  • Information technology services means services designed to do any of the following:

  • Safety Management System means a systematic approach to managing safety, including the necessary organizational structures, accountabilities, policies and procedures;

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;