First-to-File Generics

 

First-to-File Generics - Overview

Generic manufacturers face fierce competition as soon as the patent expires for the reference innovator drug product. Therefore, the US FDA provides an incentive for the first-to-file generic drug applicants challenging patent drugs, by granting a one hundred and eighty (180)-day period of exclusivity. To be eligible for this exclusivity, the generic applicant must be the first to file a complete Abbreviate New Drug Application (ANDA) containing a paragraph IV certification to a patent listed in the Orange Book.

Freyr has a broad range of cost-effective services and solutions that address the client’s business challenges through appropriate commercial and portfolio management strategies. This is aimed at providing ‘First-to-File’ and ‘First-to-Market’ opportunities for generic pharmaceutical companies along with the preparation of risk mitigation plans to accelerate drug approvals by minimizing the Refuse-to-Receive (RTR) from Health Authorities and preventing any unexpected delays in review cycles of first-to-file generic drug applications.

Our professionals have extensive knowledge and experience in registration activities, offering end-to-end ANDA services for manufacturers/sponsors/ANDA applicants and thus, can be a preferred Regulatory partner to ensure ANDA approval right at the first time.

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​