Is there a generic for Desloratadine?

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Desloratadine, referencing the brand CLARINEX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Desloratadine?

CLARINEX (NDA 021312, ORGANON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Desloratadine are approved?

Desloratadine is approved in the following dosage forms: solution, tablet, tablet, orally disintegrating.

FDA Orange Book · active-ingredient family

Desloratadine

Desloratadine: 3 brands, 11 generics; first approved Dec 21, 2001; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 11 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CLARINEXRLD

ORGANONNDA 02131220052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—
2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING	ORAL	Discontinued	—

CLARINEXRLD

ORGANON LLCNDA 0213002004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION	ORAL	Discontinued	—

CLARINEXRLDRS

ORGANONNDA 0211652001

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

Abbreviated applications

Generic (ANDA) products (11)

DESLORATADINERS

TAROANDA 2029362016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/ML	SOLUTION	ORAL	Rx	—

DESLORATADINE

TAROANDA 2025922015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/ML	SOLUTION	ORAL	Discontinued	—

DESLORATADINE

AJENAT PHARMSANDA 0783552012

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

DESLORATADINE

NATCO PHARMA USAANDA 0783512012

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

DESLORATADINE

PERRIGOANDA 0783612011

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

DESLORATADINE

DR REDDYS LABS LTDANDA 0783652011

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

DESLORATADINE

CHARTWELL RXANDA 0783642010

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

DESLORATADINE

SUN PHARM INDSANDA 0783592010

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

DESLORATADINE

LUPIN PHARMSANDA 0783522010

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

DESLORATADINE

REDDYSANDA 07836720102 strengths

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

DESLORATADINE

ORBION PHARMSANDA 0783572010

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

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Dec 21, 2001

24 yr 11 mo ago

Most recent approval

May 26, 2016

10 yr 3 mo ago

Approvals span 2001–2016 across 14 FDA applications.

Brand (NDA) 321%

Generic (ANDA) 1179%

Desloratadine — 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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