Generic Medicines Approval Route - US Market -ANDA Certification

- January 18, 2021

Registration The step in bringing a new medicine to market is the filing of an application with the health regulatory authority of a country in order to obtain approval to market the new medicine. This step is known as registration.

In the US, a New Drug Application (NDA) or Biologic Licence Application (BLA) is filed with the US Food and Drug Administration (FDA).

In Europe, a Marketing Authorization Application (MAA) is filed with the European Medicines Agency (EMA), or local competent authority, dependent on the approval route being used.

A description of the medicine's manufacturing process along with quality data and trial results are provided to the health regulatory authorities in order to demonstrate the safety and effectiveness of the new medicine. If approval is granted, the new medicine can be marketed for use by patients.

For Generic medicines submission of an ANDA in the US, or a generic MAA in Europe is required to obtain the marketing approval. Generic medicine applications do not need to contain the pre-clinical and clinical studies required for originator medicines, with relatively simple bioequivalence studies being acceptable in their place.

Generic Medicines in the US Market: ANDA Certification

ANDA Certification Clauses
Paragraph I	Paragraph II	Paragraph III	Paragraph IV
Required patent information has not been filed	Patent has expired	Patent not expired, will be expired on a specific date.	Patent is invalid or nor infringed by generic applicant
FDA may approve generic immediately, one or more applicant may enter	FDA may approve generic immediately, one or more applicant may enter	FDA many approve ANDA effective on the date of expiration, one or more applicant may enter.	Generic applicant file noticed to patient holder. A. Clause: 45 days If patent holder does not sue applicant, FDA may approve ANDA. If patent applicant holder sues the Applicant, 30 months stay granted to patent holder. The 30-month stay protects the patent owner from the harm that could otherwise ensue from the FDA granting marketing approval to a potentially infringing product. B. Clause 30 Months Stay If 30 Month Expired: ANDA applicant may grant approval (180 days exclusivity). 30 Months stay not expired: Based on judgement outcome, FDA either approve ANDA with 180 days exclusivity or will approve the ANDA after patent expiry.