Is there a generic for Beclomethasone dipropionate?

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

What is the reference-listed drug for Beclomethasone dipropionate?

QVAR REDIHALER (NDA 207921, NORTON WATERFORD) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Beclomethasone dipropionate?

The Orange Book lists 20 patents against Beclomethasone dipropionate products, with the earliest listed expiry in 2028. 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 Beclomethasone dipropionate are approved?

Beclomethasone dipropionate is approved in the following dosage form: aerosol, metered.

FDA Orange Book · active-ingredient family

Beclomethasone dipropionate

Beclomethasone dipropionate: 8 brands, 1 generic; first approved Dec 24, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Sep 07, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 07, 2028

in 2 yr 1 mo

Brand (NDA) products

Originator applications

QVAR REDIHALERRLDRS
NORTON WATERFORDNDA 20792120172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.04MG/INH AEROSOL, METERED INHALATION Rx —
0.08MG/INH AEROSOL, METERED INHALATION Rx —
QNASLRLD
TEVA BRANDED PHARMNDA 20281320142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.08MG/ACTUATION AEROSOL, METERED NASAL Rx —
0.04MG/ACTUATION AEROSOL, METERED NASAL Rx —
QVAR 40RLD
TEVA BRANDED PHARMNDA 02091120002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.08MG/INH AEROSOL, METERED INHALATION Discontinued —
0.04MG/INH AEROSOL, METERED INHALATION Discontinued —
VANCERIL DOUBLE STRENGTH
SCHERINGNDA 0204861996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.084MG/INH AEROSOL, METERED INHALATION Discontinued —
BECLOVENT
GLAXOSMITHKLINENDA 018153—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/INH AEROSOL, METERED INHALATION Discontinued —
VANCERIL
SCHERINGNDA 017573—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/INH AEROSOL, METERED INHALATION Discontinued —
BECONASE
GLAXOSMITHKLINENDA 018584—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/INH AEROSOL, METERED NASAL Discontinued —
VANCENASE
SCHERINGNDA 018521—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.042MG/INH AEROSOL, METERED NASAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.04MG/INH	AEROSOL, METERED	INHALATION	Rx	—
0.08MG/INH	AEROSOL, METERED	INHALATION	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.08MG/ACTUATION	AEROSOL, METERED	NASAL	Rx	—
0.04MG/ACTUATION	AEROSOL, METERED	NASAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.08MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—
0.04MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.084MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/INH	AEROSOL, METERED	INHALATION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/INH	AEROSOL, METERED	NASAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.042MG/INH	AEROSOL, METERED	NASAL	Discontinued	—

Generic (ANDA) products (1)

Abbreviated applications

BECLOMETHASONE DIPROPIONATERS
AMNEAL IRELAND LTDANDA 21381120252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.04MG/INH AEROSOL, METERED INHALATION Rx —
0.08MG/INH AEROSOL, METERED INHALATION Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.04MG/INH	AEROSOL, METERED	INHALATION	Rx	—
0.08MG/INH	AEROSOL, METERED	INHALATION	Rx	—

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
8132712	Sep 07, 2028	in 2 yr 1 mo	ProductDelisted
10022510	May 18, 2031	in 4 yr 10 mo	ProductDelisted
10086156	May 18, 2031	in 4 yr 10 mo	ProductDelisted
9808587	May 18, 2031	in 4 yr 10 mo	ProductDelisted
9463289	May 18, 2031	in 4 yr 10 mo	ProductDelisted
10022509	May 18, 2031	in 4 yr 10 mo	ProductDelisted
11395889	May 18, 2031	in 4 yr 10 mo	ProductDelisted
10695512	May 18, 2031	in 4 yr 10 mo	ProductDelisted
8931476	Jul 17, 2031	in 5 yr	Product
10188811	Oct 21, 2031	in 5 yr 3 mo	Product
10561808	Jan 01, 2032	in 5 yr 5 mo	ProductDelisted
12296089	Jan 26, 2038	in 11 yr 7 mo	Product
11793953	Jan 26, 2038	in 11 yr 7 mo	Product
11395888	Jan 26, 2038	in 11 yr 7 mo	Product
11865247	Jan 26, 2038	in 11 yr 7 mo	ProductDelisted
11896759	Jan 26, 2038	in 11 yr 7 mo	ProductDelisted
10792447	Jan 25, 2039	in 12 yr 7 mo	Product
11559637	Jul 21, 2039	in 13 yr 1 mo	Product
11957832	May 05, 2041	in 14 yr 11 mo	Product
11583643	Aug 19, 2041	in 15 yr 2 mo	Product

Approval history

FDA approval span

First approval

Dec 24, 1996

30 yr 1 mo ago

Most recent approval

Dec 16, 2025

8 mo ago

Approvals span 1996–2025 across 9 FDA applications.

Brand (NDA) 889%

Generic (ANDA) 111%

Beclomethasone dipropionate: 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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