Beclomethasone dipropionate - Generic Drug Details

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What are the generic sources for beclomethasone dipropionate and what is the scope of patent protection?

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 six patent family members in thirty-three countries.

There are seventeen drug master file entries for beclomethasone dipropionate. One supplier is listed for this compound.

Summary for beclomethasone dipropionate

International Patents:	306
US Patents:	14
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	91
Patent Applications:	7,272
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for beclomethasone dipropionate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	BECONASE	beclomethasone dipropionate	AEROSOL, METERED;NASAL	018584-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for beclomethasone dipropionate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019145514		⤷ Sign Up
China	105597204	DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF	⤷ Sign Up
European Patent Office	2135199	INHALATEUR À MESURE DE DOSES (METERED-DOSE INHALER)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.