The drug price competition and patent term restoration act better known as the hatch waxman act is a comprehensive legal framework enacted by congress in 1984 to streamline the process for generic pharmaceutical approvals and preserve incentives for innovation including the creation of a procedure for patient litigation involving generic pharmaceuticals. Conclusion the hatch waxman act extended the life of the pharmaceutical patents up to 14 years from the time the new drug application is approved by the fda provided additional market exclusivity for the new uses or new formulations allowed potential generic manufacturers to conduct work related to marketing approval of the drug. Hatch waxman agreement grand bargain for brand and generic industries brand industry gains section 505 j 5 f.
