Question 1

Is there a generic for Amlodipine besylate; indapamide; telmisartan?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Amlodipine besylate; indapamide; telmisartan. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Amlodipine besylate; indapamide; telmisartan?

Accepted Answer

WIDAPLIK (NDA 219423, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Amlodipine besylate; indapamide; telmisartan?

Accepted Answer

The Orange Book lists 3 patents against Amlodipine besylate; indapamide; telmisartan products, with the earliest listed expiry in 2038. 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 Amlodipine besylate; indapamide; telmisartan have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 3 marketing-exclusivity periods for Amlodipine besylate; indapamide; telmisartan. 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 Amlodipine besylate; indapamide; telmisartan are approved?

Accepted Answer

Amlodipine besylate; indapamide; telmisartan is approved in the following dosage form: tablet.

Patent	Expires	In	Type
10322117	Jan 23, 2038	in 11 yr 9 mo	Product
12465599	Jan 23, 2038	in 11 yr 9 mo	Product
10799487	Jan 23, 2038	in 11 yr 9 mo	ProductU-3448

Amlodipine besylate; indapamide; telmisartan

Brand (NDA) products · tablet

Marketing exclusivity (3)

Listed patents (3)

Amlodipine besylate; indapamide; telmisartan — frequently asked questions

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