Useni Reddy Mallu et al., IJSID, 2012, 2 (4), 96-112 International Journal of Science Innovations and Discoveries, Volume 2, Issue 4, July-August 2012 96 ANDA PARAGRAPH-IV FILINGS: A COMPLETE REVIEW Useni Reddy Mallu * , Sekhar Karanam and Panyala Srinath Reddy Dept. of Chemistry, Sri Krishnadevaraya University, Anantapur, Andhra Pradesh, India INTRODUCTION INTRODUCTION ISSN:2249-5347 IJSID International Journal of Science Innovations and Discoveries An International peer Review Journal for Science Review Article Available online through www.ijsidonline.info Received: 16.07.2012 Accepted: 29.08.2012 *Corresponding Author Address: Name: Dr. Useni Reddy Mallu Place: Dept. of Chemistry, Sri Krishnadevaraya University, Anantapur, Andhra Pradesh, India E-mail: drusenireddymallu@gmail.com ABSTRACT The present review throws light on the criticalities and complexities involved in the paragraph IV ANDA filings with USFDA and the intellectual property litigations evolving around between the branded manufacturers and generic companies. Hatch-Waxman Act grant generic manufacturers the ability to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement. The entry of generic product in to the market allows the public to have access to low cost medicines equivalent to brand products. Once multiple generic firms enter the market, prices fall, often dramatically. The current generic approval process involves submission of only an abbreviated new drug application (ANDA) that relies on FDA approval of the pioneer drug (or patented brand name drug) to demonstrate safety and effectiveness. The generic drug does not require proof that it is safe and effective--that has already been proven by the brand name drug manufacturer and through many years of clinical use in the general population. Generally, the ANDA has to establish only that the generic drug is bioequivalent to the pioneer drug (i.e., the reference-listed drug for which therapeutic equivalence is sought). The Hatch-Waxman Act gave additional protection to the inventors of new drugs,both by lengthening patent terms and by providing guaranteed periods of data exclusivity.In exchange, Hatch-Waxman made it easier for generic drug manufacturers to enter the market with a copy of the drug, either by waiting until the patent expires or by challenging weak patents. To encourage generic manufacturers to identify and challenge weak patents, Hatch-Waxman offered a sort of incentive to the generic challenger. The first generic manufacturer to file for approval with the FDA, as paragraph IV is entitled to 180 days of “generic exclusivity” when it first enters the market. During that period, other generic drug makers are prohibited from entering the market. The point was to offer an incentive, encouraging generic firms to challenge and invalidate bad patents (or invent around them) early and often, and accordingly get generic drugs on to the market earlier. Multiple ANDA filings on the same day would lead to sharing the exclusivity between generic manufacturers. 30-month FDA stay period and patent infringement litigations became a common scenario in the growing global generic pharmaceutical industry. with very little downside and huge upside, exclusivity is the driving force to the huge increase in first-to-file Paragraph IV filings. Keywords: USFDA-ANDA submission, Orange book, Paragraph-IV filing, 30months stay period, Litigations, 180days exclusivity, Multiple ANDA submission, Hatch Waxman act, CFR , First to file and case studies.