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THE PHARMA REVIEW (JAN – FEB 2020)

Systematic Process for Filing of Para–IV Certification and Court Litigations

G. Tanuja Lakshmi1, A. Sireesha & Lakshmi Prasanthi Nori*2

Introduction:

USFDA is one of the most stringent regulatory agency where the submission process is very critical. The present review discloses on how to submit ANDA application as per FDA, CDER guidelines in paragraph-IV submission as per Federal Food and Drug Cosmetic Act and criticalities as well as complexities which are involved in the Para-IV ANDA filing and intellectual property litigations evolving around between the branded manufacturer and generic companies. No drug would be available in the market until and unless it get approved by the regulatory authorities. Para-IV Certifications is useful for exclusive right to market the generic drug for 180-days. A generic product must meet the standards which are established by the FDA in RLD Orange book serves as the “Gold Standard Reference” for generic drug substitution. The Hatch-Waxman Act made it easier for the generic drug manufactures to enter the market with a copy of the drug, either by waiting until the patent expires or by challenging the weak patents and also to encourage the generic manufactures to identify and challenge the weak patents. The first generic manufacturer to file for approval with the FDA, as paragraph IV is entitled to the 180 days of the “generic exclusivity” when it first enters the market. FDA stay period of 30-month and patent infringement litigations became a common scenario in the growing global generic pharmaceutical industry. This study covers the ANDA submission process to FDA and its acts related to the submission in Para-IV.

 

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