Is there a generic for Amlodipine benzoate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Amlodipine benzoate, referencing the brand KATERZIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amlodipine benzoate?

KATERZIA (NDA 211340, AZURITY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Amlodipine benzoate?

The Orange Book lists 13 patents against Amlodipine benzoate products, with the earliest listed expiry in 2037. 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.

What dosage forms of Amlodipine benzoate are approved?

Amlodipine benzoate is approved in the following dosage form: suspension.

FDA Orange Book · active-ingredient family

Amlodipine benzoate

Amlodipine benzoate: 1 brand, 1 generic; first approved Jul 08, 2019; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Oct 06, 2037

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 06, 2037

in 11 yr 4 mo

Brand (NDA) products

Originator applications

KATERZIARLDRS
AZURITYNDA 2113402019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SUSPENSION ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SUSPENSION	ORAL	Rx	—

Generic (ANDA) products (1)

Abbreviated applications

AMLODIPINE BENZOATE
AMNEALANDA 2150352023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SUSPENSION ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/ML	SUSPENSION	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10959991	Oct 06, 2037	in 11 yr 4 mo	U-39
10894039	Oct 06, 2037	in 11 yr 4 mo	U-3
11471409	Oct 06, 2037	in 11 yr 4 mo	U-3447
12336984	Oct 06, 2037	in 11 yr 4 mo	U-3447
11918685	Oct 06, 2037	in 11 yr 4 mo	U-3447
11701326	Oct 06, 2037	in 11 yr 4 mo	Product
11484498	Oct 06, 2037	in 11 yr 4 mo	Product
10952998	Oct 06, 2037	in 11 yr 4 mo	Product
12383498	Oct 06, 2037	in 11 yr 4 mo	Product
11364230	Oct 06, 2037	in 11 yr 4 mo	Product
12053461	Oct 06, 2037	in 11 yr 4 mo	Product
10695329	Oct 16, 2037	in 11 yr 4 mo	Product
10799453	Apr 11, 2039	in 12 yr 10 mo	Product

Approval history

FDA approval span

First approval

Jul 08, 2019

7 yr 2 mo ago

Most recent approval

Jun 13, 2023

3 yr 3 mo ago

Approvals span 2019–2023 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Amlodipine benzoate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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