Question 1

Is there a generic for Alogliptin benzoate; metformin hydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Alogliptin benzoate; metformin hydrochloride. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Alogliptin benzoate; metformin hydrochloride?

Accepted Answer

KAZANO (NDA 203414, TAKEDA PHARMS USA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Alogliptin benzoate; metformin hydrochloride?

Accepted Answer

The Orange Book lists 2 patents against Alogliptin benzoate; metformin hydrochloride products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Alogliptin benzoate; metformin hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Alogliptin benzoate; metformin hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Alogliptin benzoate; metformin hydrochloride are approved?

Accepted Answer

Alogliptin benzoate; metformin hydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7807689	Jun 27, 2028	in 2 yr 1 mo	SubstanceProductU-1337
8900638	May 24, 2029	in 3 yr	Product

Alogliptin benzoate; metformin hydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (2)

Listed patents (2)

Alogliptin benzoate; metformin hydrochloride — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.