NCE-1 filing: scenario year-to-date

Year-to-date, the FDA has reported paragraph IV ANDA submissions against 11 brand products having NCE-1 dates in 2019. Most of them are the oral solid products with just two exceptions, one being injectable while the other being oral liquid.

Sacubitril/Valsartan witnessed the highest number of ANDA filers (19) while Patiromer and Cangrelor witnessed the lowest number of ANDA filers (two against each of them).

See below the complete list of New Chemical Entities (NCEs) that witnessed Paragraph IV ANDA submission in 2019.

Active Ingredient	Dosage form	Brand Name	No. Of ANDA submitted
Sacubitril and Valsartan	Oral Tablets	Entresto	19
Trifluridine and Tipiracil	Oral Tablets	Lonsurf	4
Brexpiprazole	Oral Tablets	Rexulti	18
Cariprazine	Oral Capsules	Vraylar	3
Eluxadoline	Oral Tablets	Viberzi	6
Ivabradine	Oral Tablets	Corlanor	6
Patiromer	Oral Suspension	Veltassa	2
Cangrelor	Injectable	Kengreal	2
Palbociclib	Oral Capsules	Ibrance	>10*
Lenvatinib	Oral Capsules	Lenvima	N/A
Edoxaban	Oral Tablets	Savaysa	N/A

 

*Based on the number of lawsuits of Patent Infringement

Which, do you consider is the better business case for a generic company?

1) The brand product with good sales number but have 20 first filers, or

2) The brand product with moderate to low sales numbers and has only 2-3 first filers.

If you want information on open First-To-File opportunities grabbed by the generic filers in 2019, then write us at pharmacaption@gmail.com.