Is there a generic for Amlodipine besylate?

Yes. The FDA Orange Book lists 39 approved generic (ANDA) applications for Amlodipine besylate, referencing the brand SDAMLO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amlodipine besylate?

SDAMLO (NDA 219531, BRILLIAN PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Amlodipine besylate?

The Orange Book lists 6 patents against Amlodipine besylate products, with the earliest listed expiry in 2041. 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 besylate are approved?

Amlodipine besylate is approved in the following dosage forms: for solution, solution, tablet, tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Amlodipine besylate

Amlodipine besylate: 4 brands, 39 generics; first approved Jul 31, 1992; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 39 ANDA applications approved.

Earliest patent expiry Feb 24, 2041

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Feb 24, 2041

in 14 yr 9 mo

Brand (NDA) products

Originator applications

SDAMLORLDRS
BRILLIAN PHARMANDA 21953120253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE/BOT FOR SOLUTION ORAL Rx —
EQ 5MG BASE/BOT FOR SOLUTION ORAL Rx —
EQ 10MG BASE/BOT FOR SOLUTION ORAL Rx —
NORLIQVARLDRS
CMP DEV LLCNDA 2144392022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/ML SOLUTION ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE/BOT	FOR SOLUTION	ORAL	Rx	—
EQ 5MG BASE/BOT	FOR SOLUTION	ORAL	Rx	—
EQ 10MG BASE/BOT	FOR SOLUTION	ORAL	Rx	—

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

AMLODIPINE BESYLATERLD

SYNTHON PHARMSNDA 02202620073 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—

NORVASCRLD
VIATRISNDA 01978719923 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Generic (ANDA) products (39)

Abbreviated applications

AMLODIPINE BESYLATE
GRAVITI PHARMSANDA 20138020263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
EQ 2.5MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
TEVA PHARMS INCANDA 21968620263 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
SUNSHINEANDA 20652420183 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
PURACAP LABS BLUANDA 20782120163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
CHINA RESOURCESANDA 09075220163 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
EQ 2.5MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
INVAGEN PHARMSANDA 20636720153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
SOVEREIGN PHARMSANDA 20490020153 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
UNICHEMANDA 20324520133 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
ACCORD HLTHCAREANDA 20255320133 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
HIKMA PHARMSANDA 07777120113 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
OXFORD PHARMSANDA 07841420103 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
ORBION PHARMSANDA 07845320093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
ALKEMANDA 07892520093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
EPIC PHARMA LLCANDA 07855220093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
TORRENT PHARMSANDA 07857320083 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
PHARMOBEDIENTANDA 07822420083 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
SUN PHARM INDUSTRIESANDA 07808120083 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
AMNEAL PHARMS NYANDA 07847720083 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
SUN PHARM INDS INCANDA 07823120073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
CIPLAANDA 07707320073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
CHARTWELL RXANDA 07685920073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
WOCKHARDTANDA 07850020073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
PURACAP PHARMANDA 07813120073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
INVAGEN PHARMSANDA 07795520073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
CHARTWELL RXANDA 07669220073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
WATSON LABSANDA 07767120073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
AUROBINDO PHARMAANDA 07802120073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
GEDEON RICHTER USAANDA 07733320073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
LUPINANDA 07804320073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
STRIDES PHARMAANDA 07751620073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
GENPHARMANDA 07736220073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
HIKMAANDA 07726220073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
SCIEGEN PHARMSANDA 07775920073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
SUN PHARM INDS LTDANDA 07797420073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
ZYDUS PHARMS USAANDA 07822620073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
TEVAANDA 07684620073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
SYNTHON PHARMSANDA 07708020073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —
AMLODIPINE BESYLATE
COREPHARMAANDA 07671920073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Rx AB
EQ 5MG BASE TABLET ORAL Rx AB
EQ 10MG BASE TABLET ORAL Rx AB
AMLODIPINE BESYLATE
MYLANANDA 07641820053 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2.5MG BASE TABLET ORAL Discontinued —
EQ 5MG BASE TABLET ORAL Discontinued —
EQ 10MG BASE TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Rx	AB
EQ 5MG BASE	TABLET	ORAL	Rx	AB
EQ 10MG BASE	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE	TABLET	ORAL	Discontinued	—
EQ 5MG BASE	TABLET	ORAL	Discontinued	—
EQ 10MG BASE	TABLET	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
12226528	Feb 24, 2041	in 14 yr 9 mo	ProductU-3309
11458095	Feb 24, 2041	in 14 yr 9 mo	ProductU-3309
12005141	Feb 24, 2041	in 14 yr 9 mo	ProductU-3311
12440441	Feb 24, 2041	in 14 yr 9 mo	ProductU-3309
11723866	Feb 24, 2041	in 14 yr 9 mo	ProductU-3309
11253474	Feb 24, 2041	in 14 yr 9 mo	ProductU-3309

Approval history

FDA approval span

First approval

Jul 31, 1992

34 yr 7 mo ago

Most recent approval

Feb 17, 2026

6 mo ago

Approvals span 1992–2026 across 43 FDA applications.

Brand (NDA) 49%

Generic (ANDA) 3991%

Amlodipine besylate: 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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