HOW MUCH TIME IS ENOUGH TO GRAB FIRST FILER’S SPOT IN NEW STRENGTHS OF EXISTING NDAs?

With increase in the number of companies filing their ANDAs on NCE-1 date, more and more generic companies are now focusing on OPEN FIRST TO FILE opportunities. However, success is very limited in the open first to file (FTF) opportunities as there is only one company that wins the race. Moreover, success in open FTF depends on many factors starting from the timing of identification of such opportunity to the development of non-infringing, bio-equivalent product.

We have reviewed open FTF opportunities of the last calendar year (2018). For this post, we have considered the first Para IV filings done in 2018 against new strengths of the existing NDAs.

Table 1. First Para IV filings in 2018 against new strengths of the existing NDAs

Product	Date of NDA Approval	Paragraph four filing	Duration between NDA approval and first PIV filing (days)
Rivaroxaban 2.5 mg	11 Oct. 2018	19 Nov. 2018	39
Fingolimod 0.25 mg	11 May 2018	18 July 2018	68
Carfilzomib 10 mg injection	7 June 2018	28 Nov. 2018	174
Bosutinib 400 mg tablets	27 Oct. 2017	15 Oct. 2018	354
Ibrutinib 70 mg capsules	20 Dec. 2017	14 Dec. 2018	360
Dapagliflozin/Metformin ER tablets (2.5 mg/1 gm)	28 July 2017	29 Oct. 2018	459
Source: fda.gov

 

Chart 1. First Para IV filings in 2018 against new strengths of the existing NDAs

          As noted above, first PIV filings in the billionaire products like Rivaroxaban (2.5 mg) and Fingolimod (0.25 mg) was done within less than 75 days from their corresponding NDA approval. This is only possible with much early identification of such opportunities. Availability of bio-waiver in the lower strengths of solid orals and injectable products also makes it possible to submit ANDAs within short duration of NDA approval.

Our upcoming post will cover the remaining open FTF opportunities grabbed by generics in 2018.