ANDA is for a generic duplicate of an approved NDA product. Abbreviated New Drug Application contains data that, when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product:
•Gets safety and efficacy studies from NDA
•Must have identical active ingredient, route of administration, dosage form, strength, labeling and intended use
•Must demonstrate bioequivalence
Types of ANDA:
Para I: A Para I filing for the launch of generic drug is made when the innovator has not made the required information in the Orange book.
Para II: A Para II filing is made when the drug is already off patent.
Para III: A Para III filing is made when the applicant does not have any plans to sell the generic drug until the original drug is off patent.
Para IV: A Para IV filing for the launch of generic drug is made when the applicant believes its product or the use of its product does not infringe on the innovator’s patents or where the applicant believes such patents are not valid or enforceable.
1.Applicant files the application to USFDA for ANDA paragraph- IV certification.
2.Patent holder has to be notified of application by the Applicant within 20 days.
3.Litigation starts in court, if patentee files infringement suit against ANDA applicant within 45 days from receiving of notification in the court.
4.When court gets the infringement suit, it gives 30 months stay for the FDA to approve the application, otherwise FDA can approve or disapprove the application; no stay would be given to the FDA.
5.If Court decision is in respect to applicant, he gets the 180 days market exclusivity (in this exclusivity period, no one other than applicant can market the product for 180 days) if the decision is against the applicant, then the available option will be Para-II/III
6.If 30 months stay is directed by the court then FDA is not allowed from approving the application for 30 months. Or until court holds that the patent is invalid or would not be infringed. Alternatively if court gives decision in favor of patentee, FDA will not approve ANDA.
7.Once 30 months have passed, FDA will approve the application, even though litigation is ongoing and after approval both parties can market their product until the decision would be given by the court within the patent expiration period.
FDA Review Procedure:
1.As a part of the review process FDA will send the application of the applicant to OGD/CDER review team for the approval.
2.If the submitted application is not complete or any deficiencies are identified, then “refuse to file letter” is issued by the OGD/CDER to the applicant.
3.In case the application has found complete without any deficiencies then it’s accepted & application is then sent to the internal review team for the identification of Bio-Equivalence, Chemistry/Microbiology, Plant inspection & Labeling review issues.
4.If any pending results are found in the application, Bio-Equivalence deficiency letter, & pending satisfactory results are issued accordingly to the applicant.
5.Once the ANDA submission is complete and acceptable without any further queries, the applicant finally receives FDA approval letter.