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  1. 1. Roshan Gomaji Bodhe Pharmaceutics (M. Pharm. Sem1) SES,RCPIPER Shirpur Campus
  2. 2. WHAT IS A DRUG? “Any product used to diagnose, cure, mitigate, treat, or prevent a disease.”
  3. 3. Stage 1 Drug Discovery Stages of Drug Development and Review The Drug Discovery, Development, and Review Process Stage 2 Preclinical Stage 3 Clinical Trials Stage 4 FDA Review 6.5 years 7 years 1.5 years Phase 1 20-100 volunteers Phase 3 1,000-5,000 volunteers Phase 2 100-500 volunteers INDsubmitted NDAsubmitted 250 compounds 5 compounds 10,000 compounds 1 FDA approved drug Stage 5 Post Marketing Trials Phase 4 several hundred to several thousand Entire Life Cycle
  4. 4. What is GENERIC DRUG Product?  A Generic Drug product is a drug product that is comparable to an innovator drug product (also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristic, and intended use.  Another definition include that Generic drug product is that drug product which is free from any patent or copyright protection.
  5. 5. GENERICS Active ingredients Purity and quality Amount absorbed Dosage Manufacturer’s processing Safety Efficacy
  6. 6. Marketplace Branded Generic Generic Entrance to Marketplace Patents and Exclusivity Generics are unable to gain access to the marketplace
  7. 7. The Cycle of Innovation and Competition Branded company innovates Branded company rewarded with monopoly position Generics are distributed; branded company loses revenue Patent expiration opens market to generic competition Branded company innovates Branded company rewarded with monopoly position Patent expiration opens market to generic competition Generics are distributed; branded company loses revenue
  8. 8. The Hatch-Waxman Act/ Drug Price Competition/ Patent Term Restoration Act (1984)  "The Hatch-Waxman Act is an act dealing with the approval of generic drugs and associated conditions for getting their approval from the Food and Drug Administration (FDA), market exclusivity, rights of exclusivity, patent term extension and Orange Book Listing."  The act was enacted in the USA in 1984.
  9. 9.  It was necessitated by the following observations:  Absence of Generic drug manufacturing: Sometime in the year 1962 it was observed in the USA that out of the 150 off patent drugs in the market, there were no generic drugs! Owing to cumbersome procedures involved, manufacturers were simply not interested to take up manufacture of these, even though these were cheaper.  Cumbersome regulatory procedures: Many companies did not go in for manufacture of generic drugs because of the impractical and non-scientific manner in which the regulatory authorities viewed the approval process and insisted upon proving the obvious.  Patients were denied the option of cheaper
  10. 10. HATCH-WAXMAN ACT (1984) LINKED FDA APPROVAL AND PATENT PROTECTION  Hatch-Waxman applies only to drugs.  It balanced interests of research companies and generic companies.  Generic companies are now able to use a patented drug to establish acts related to FDA approval.
  11. 11. HATCH-WAXMAN EXCLUSIVITY PROVISIONS  Innovator companies may get “patent term restoration” equal to delay of approval by FDA, up to 5 years, called “marketing exclusivity”.  Innovator companies also get protection of safety and effectiveness data for 5 years after NDA approval, so-called “data exclusivity”.  Brand drug companies may seek restoration of some of the patent life lost during the period of FDA testing/approval up to 5 years (or no more than 14 years between FDA approval and patent expiration).
  12. 12. Patents and Drug Exclusivity 1. Drug patents are granted by the Patent and Trademark Office and can be granted at any time during the development of a drug. 2. Drug exclusivity refers to the exclusive marketing rights granted to a drug upon its approval by the FDA.
  13. 13. FDA MARKETING APPROVAL FOR GENERIC DRUGS – ABBREVIATED NEW DRUG APPLICATION (ANDA)  Hatch-Waxman created an ANDA  After expiration of “data exclusivity,” generic companies may use safety and effectiveness data of innovator company for their ANDA.  Generic companies must only prove “bioequivalence” to the innovator’s drug product— “bioavailability” of the drug at the site of activity in the body at same potency.
  14. 14. ANDA (Abbreviated New Drug Application) “ANDA” is the abbreviation for Abbreviated New Drug Application. It contains data which when submitted to FDA’s CDER, office of generic drugs, provides for the review and ultimate approval of a generic drug product. Once approved an applicant may manufacture and market the generic drug product provided all issues related to patent protection and exclusivity associated with RLD have been resolved.
  15. 15.  Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA.  Intent is to minimize duplication of available information.  Complete chemistry, manufacturing, and controls information.  Information regarding the bioavailability of solid dosage forms.
  16. 16. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food Safety and Applied Nutrition Center for Veterinary Medicine National Center for Toxicological Research
  17. 17. Generic Drug Review Process Application submitted to Office of Generic Drugs Bioequivalence Review Plant Inspection Chemistry/Micro Review Labeling Review FDA reviews and decides if product is approved or not approvable Determine if application is acceptable Generic manufacturers do not need to complete the three phases of clinical trials
  18. 18. “PARAGRAPH IV CERTIFICATION”  A “Paragraph IV certification” by a generic company states the applicant believes the patent is invalid (or is unenforceable) or will not be infringed by the generic product.  Company must send notice to the NDA holder  Notice must include a detailed statement of factual and legal basis  NDA holder can file a patent infringement suit within 45 days of receipt of notice.  If suit is filed in 45 days, ANDA approval is delayed for 30 months (during litigation).
  19. 19. Avoiding Patent Infringement Under Hatch-Waxman Act, Generic Companies Filing ANDAs are required to certify with the FDA that their “COPYCAT” DRUGS will not infringe each and every existing patent on the innovative drug they seek to copy, which are listed in a printed compendium known as “Approved Drug Product with Therapeutic Equivalence” but most commonly called “THE ORANGE BOOK”