Is there a generic for Amlodipine besylate; celecoxib?

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

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

CONSENSI (NDA 210045, PURPLE BIOTECH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Amlodipine besylate; celecoxib?

The Orange Book lists 1 patent against Amlodipine besylate; celecoxib 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.

What dosage forms of Amlodipine besylate; celecoxib are approved?

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

FDA Orange Book · active-ingredient family

Amlodipine besylate; celecoxib

Amlodipine besylate; celecoxib: 1 brand, 0 generics; first approved May 31, 2018; on patent until Jun 14, 2038.

On patentHas discontinued products

Generic status & protection

Protected until Jun 14, 2038 (earliest listed patent expiry).

Earliest patent expiry Jun 14, 2038

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jun 14, 2038

in 12 yr 1 mo

Originator applications

Brand (NDA) products

CONSENSIRLD

PURPLE BIOTECHNDA 21004520183 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2.5MG BASE;200MG	TABLET	ORAL	Discontinued	—
EQ 5MG BASE;200MG	TABLET	ORAL	Discontinued	—
EQ 10MG BASE;200MG	TABLET	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10350171	Jun 14, 2038	in 12 yr 1 mo	Product

FDA approval span

Approval history

First approval

May 31, 2018

8 yr 3 mo ago

Most recent approval

May 31, 2018

8 yr 3 mo ago

All 1 application were approved in 2018.

Brand (NDA) 1100%

Generic (ANDA) 00%

Amlodipine besylate; celecoxib — 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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