Generic Drugs
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Project at a Glance Contents on the CD ROM
  • A generic drug is a drug which is produced and distributed without patent protection.
  • A generic must contain the same active ingredients as the original formulation.
  • A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
  • Generic drugs are important options that allow greater access to health care for all Americans.
  • Generic versions of a drug must use the same active ingredients as the brand name drug, and it must meet the same quality and safety standards.
  • Generic drugs are pharmaceuticals with off-patent agents, which are brought to market in the classical form with the international non-proprietary name (INN).
  • Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
  • A generic drug of biological type is different to chemical drugs because of its biological nature and it is regulated under extended set of rules for it.
  • Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.
  • Generic drugs are marketed under a non-proprietary or approved name rather than a proprietary or brand name.
  • Generic drugs are frequently as effective as, but much cheaper than, brand-name drugs.
  • Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition.
  • Generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.
  • Generic drugs can reduce healthcare costs through multiple pathways.
  • Generic drugs cost much less than their branded counterpart, so the high rate of generic prescribing resulted in billions of dollars of savings for the U.S. health care system.
Technology
  • Generic Drugs and Alzheimerís Disease
  • Generic Drugs Industry In India
  • Medicare Payments for Newly Available Generic Drugs
  • Provinces and Territories Seek Significant Cost Savings for Canadians on Generic Drugs
  • Self-Identification of Generic Drug Facilities, Sites, and Organizations
  • A Small Way To Reduce Healthcare Costs
  • QbD Status Update Generic Drugs
  • Generic and Brand Name Drugs Understanding the Basics
  • Generic Drug User Fee Act

Facts

  • Facts and Myths About Generic Drugs
  • Facts About Generic Drugs
  • FDA Facts and Myths about Generic Drugs
  • Top 10 Facts on Generic Drugs

Guide

  • A Guide to Generic Drugs
  • Generic Drug User Fee Amendments of 2012
  • Generic Drugs Substitute And Save

Patent

  • Technology Development Through Pooling ARV Drug Patents
  • Consumer Protection, Patents and Procedure
  • The Great Debate between Pharmaceutical Patent Holders and Generic Manufacturers
  • Patents, International Trade Law And Access To Essential Medicines
  • Reverse Settlements As Patent Invalidity Signals 
  • Trips, Pharmaceutical Patents and Access to Essential Medicines
  • Fda Exemption To Patent Infringements

Economics

  • Economics Of Aids and Access To HIV/Aids Care
  • Pharmaceuticals Law Management
  • Considering the Economic Implications of Patent Infringement
  • Generic Drugs Industry Dynamics
  • Importance of Chirality in Drug Therapy and Pharmacy Practice
  • An Economic Assessment of Patent Settlements in the Pharmaceutical Industry

Stories

  • The Complexities of Litigating Generic Drug Exclusion Claims in the Antitrust Class Action Context
  • Ideas for Potential Players
  • Unpatentable Drugs and the Standards of Patentability

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Suppliers
  • Supplier From India
  • Supplier From Mumbai

Company profiles

  • Company From Thane
  • Company From Ghaziabad
  • Company 1 From Mumbai
  • Company 2 From Mumbai
  • Company From Canada

Consultancy

  • Consultancy From Canada
  • Consultancy 1 From New York
  • Consultancy 2 From New York
  • Consultancy 1 From Usa
  • Consultancy 2 From Usa
Market
  • Cost Effective Alternate To Branded Drugs
  • The Emergence of Indiaís Pharmaceutical Industry and Implications for the U.S. Generic Drug Market
  • The price of drugs
  • The Japanese Generic Drug Market
  • The Ongoing Regulation of Generic Drugs
  • Generic Drug Prices
  • Research on Savings from Generic Drug Use

Report

  • Patent Law and Its Application to the Pharmaceutical Industry
  • Generic Substitution of Narrow Therapeutic Index Drugs
  • Postmarketing Surveillance in the Office of Generic Drugs
  • Short-Term Effects and Long-Term Impact

Study

  • Benefiting from Generic Drug Competition in Canada
  • Legal And Economic Feasibility Assessment
  • The Importance Of Generic Drugs In India
  • Generic Medications
  • Generic Drugs Utilization In The Medicare Part D Program
  • Introduction about Generic Drugs
  • Approval Review of Generic Drugs in Japan
  • Generic Drug Saving In The US
  • Tendering Generic Drugs
  • Promotion Of Use Of Generic Drugs In Japan

Process

  • The FDAís Generic-Drug Approval Process
  • Generic Drug Approval
    Process in China
  • Generic Drugs Overview Of ANDA Review Process
  • The Food And Drugs Administration's Generic Drug Review Process

Manufacturing process

  • Brazilís Generic Drug Manufacturing Success

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