The hatch waxman act

Development of Generic drug product

1. THE HATCH WAXMAN ACT By- P. R. Agrawal M. PHARM SKBCOP NAGPUR

2. INTRODUCTION Also known as The Drug Price Competition and Patent Term Restoration Act. This act was passed in 1984 by Gratch Hatch an American politician and Henry Arnold Waxman. This act is beneficial for both drug innovators and generic companies also.

3. Why this act was required? In early 1980 it was observed that very few generic companies were coming to market. After studies the issue, US congress found that generic companies were facing difficulties that time for marketing generic version due to irregular and uncertain regulatory pathway for filling the ANDA. It was also observed that there is Regulatory delay too in marketing of drug product faced by the innovator. The act provide protection to drug innovators on the other hand this act also encourages generic drug companies by faciliating and providing incentive for companies to file ANDA.

4. TYPES OF CERTIFICTAIONS There are four types of paragraphs i.e A] Para I certification B] Para II certification C] Para III certification D] Para IV certification

5. PARA I NO PATENTS LISTED This is applicable when no patent is listed in orange book. In this case FDA may approve the ANDA application immediately. One or more applicant may enter

6. PARA II PATENTS HAVE EXPIRED P ara II certified that the patent is expired. In this case also FDA approve ANDA immediately One or applicant may enter the market

7. PARA III PATENTS NOT EXPIRED AND WILL BE EXPIRES ON A SPECIFIC DATE In case patent is not expired and will be expired on a specific date. In this case FDA may approve the ANDA application which is effective on the date of expiration of the patent. One or more applicant may enter.

8. PARA IV PATENTS IS INVALID OR NOT INFRINGED In this case certification generic product applicant does not infringe on the listed patents or that those patents are not enforceable. Generic applicant (ANDA) provides notices to innovator/patent holder.

9. Benefits for Generic Companies In early period generic company have to carry out preclinical as well as clinical studies. This is time consuming as well as costly Because of this act now generic company have to submit only bioequivalence only. This state that the generic drug work similar to that of branded drug. Due to this generic drug comes in market in the period of 18 to 36 months only.

10. Benefits for Branded Company This act has made a provision fro the extension of existing patent period when innovator discover new dosages form or new indication for the patent drug. The act also has the provision to allow the life of patents covering a drug to be extended by duration of the time the drug is under regulatory review by the FDA. Under this act innovator requires to provide FDA how many patent the innovators drug covers. FDA will list those patent in the orange book without evaluating whether the patent covers the drug or not.