Approval time for CGT designated ANDAs: Review

Till date, USFDA has approved 18 ANDAs with CGT exclusivity.

We have reviewed approval details of 17 out of these 18 ANDAs. Based on that, we have come across the following facts:

·         The average approval time for these 17 ANDAs was approximately 11 months from the date of submission of ANDAs. 5 out of these 17 approved ANDAs had received CRL in the first review cycle. If we remove these 5 outliers from the average then the average approval time for the remaining 12 ANDAs was approximately 9 months.

·         The shortest approval time was 233 days (less than 8 months) while the longest approval time was 626 days (approximately 20 months).

·         More than 75% of these 17 ANDAs were approved by FDA within 12 months of the ANDA submission.

·         The average approval time for topical products was close to 9 months while the average approval time for solid oral products was slightly less than 12 months.

Want complete excel compilation of CGT designated ANDAs with the Approval time then write us at pharmacaption@gmail.com

If you have any query or suggestion then please write us at pharmacaption@gmail.com

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.