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Beclomethasone dipropionate - Generic Drug Details

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What are the generic sources for beclomethasone dipropionate and what is the scope of freedom to operate?

Beclomethasone dipropionate is the generic ingredient in eleven branded drugs marketed by Glaxosmithkline, Teva Branded Pharm, Norton Waterford, and Schering, and is included in eleven NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Beclomethasone dipropionate has three hundred and seventeen patent family members in thirty-five countries.

There are twenty drug master file entries for beclomethasone dipropionate. Three suppliers are listed for this compound.

Summary for beclomethasone dipropionate

International Patents:	317
US Patents:	13
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	20
Suppliers / Packagers:	3
Bulk Api Vendors:	57
Clinical Trials:	87
Patent Applications:	6,897
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for beclomethasone dipropionate
What excipients (inactive ingredients) are in beclomethasone dipropionate?	beclomethasone dipropionate excipients list
DailyMed Link:	beclomethasone dipropionate at DailyMed

Recent Clinical Trials for beclomethasone dipropionate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aurobindo Pharma Ltd	Phase 3
Adamis Pharmaceuticals Corporation	Phase 3
Amneal Ireland Limited	Phase 3

See all beclomethasone dipropionate clinical trials

Pharmacology for beclomethasone dipropionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for BECLOMETHASONE DIPROPIONATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
QVAR 80	AEROSOL, METERED;INHALATION	beclomethasone dipropionate	020911	2020-01-10
QVAR 40	AEROSOL, METERED;INHALATION	beclomethasone dipropionate	020911	2020-01-10

US Patents and Regulatory Information for beclomethasone dipropionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No			Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No			Y
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No			Y

Expired US Patents for beclomethasone dipropionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	BECLOVENT	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	018153-001	Approved Prior to Jan 1, 1982
Schering	VANCENASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018521-001	Approved Prior to Jan 1, 1982
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017
Schering	VANCERIL	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	017573-001	Approved Prior to Jan 1, 1982
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017

International Patents for beclomethasone dipropionate

Country	Patent Number	Estimated Expiration
China	105903111
Poland	2627386
China	105597205
Japan	2014111199
Cyprus	1116358
Spain	2496741
Japan	2015231585