Beclomethasone dipropionate - Generic Drug Details

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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for beclomethasone dipropionate

International Patents:	304
US Patents:	14
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	91
Patent Applications:	7,365
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
SOFAR S.p.A.	Phase 1
Pharmactive Ilac Sanayi ve Tic A.S.	Phase 1/Phase 2
Aurobindo Pharma Ltd	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	Strength	NDA	ANDAs Submitted	Submissiondate
QVAR 80	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation and 80 mcg/actuation	020911	1	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	207921-002	Aug 3, 2017		RX	Yes	No			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	Yes	No			Y
Schering	VANCENASE AQ	beclomethasone dipropionate monohydrate	SPRAY, METERED;NASAL	019589-001	Dec 23, 1987		DISCN	No	No
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
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No			Y
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for beclomethasone dipropionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	VANCENASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018521-001	Approved Prior to Jan 1, 1982
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000
Schering	VANCERIL DOUBLE STRENGTH	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020486-001	Dec 24, 1996
Glaxosmithkline	BECLOVENT	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	018153-001	Approved Prior to Jan 1, 1982
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014
Schering	VANCENASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018521-001	Approved Prior to Jan 1, 1982

International Patents for beclomethasone dipropionate

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201300232	ВАЛ ДЛЯ УДЕРЖИВАНИЯ ЛЕНТЫ СЧЕТЧИКА В СЧЕТЧИКЕ ДОЗ, СБОРОЧНЫЙ УЗЕЛ ВАЛА И ЛЕНТЫ СЧЕТЧИКА, СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННОГО ВЕЩЕСТВА
Denmark	2514462
Mexico	2012012956	CONTADORES DE DOSIS PARA INHALADORES, INHALADORES Y FLECHAS DE LOS MISMOS. (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF.)
Spain	2544501
Portugal	2502644
South Africa	201301938	NASAL SPRAY DEVICE
Eurasian Patent Organization	023985	ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННЫХ ВЕЩЕСТВ И СПОСОБ СБОРКИ ИНГАЛЯТОРА (INHALER FOR INHALATION OF MEDICINAL SUBSTANCES AND METHOD FOR INHALER ASSEMBLING)