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

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

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

Summary for beclomethasone dipropionate

International Patents:	327
US Patents:	20
Tradenames:	11
Applicants:	4
NDAs:	11
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	94
Patent Applications:	7,778
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for beclomethasone dipropionate

Generic Entry Dates for beclomethasone dipropionate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: AEROSOL, METERED;INHALATION
Generic Entry Dates for beclomethasone dipropionate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: AEROSOL, METERED;INHALATION
Generic Entry Dates for beclomethasone dipropionate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: AEROSOL, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for beclomethasone dipropionate

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

Sponsor	Phase
SGS S.A.	Phase 1
Chiesi Farmaceutici S.p.A.	Phase 1
Mardan Medical Complex	Early Phase 1

See all beclomethasone dipropionate clinical trials

Generic filers with tentative approvals for BECLOMETHASONE DIPROPIONATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.08MG/INH	AEROSOL, METERED;INHALATION
⤷ Sign Up	⤷ Sign Up	0.04MG/INH	AEROSOL, METERED;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 REDIHALER	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation	207921	1	2023-10-30
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
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	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	207921-002	Aug 3, 2017		RX	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
Schering	VANCENASE AQ	beclomethasone dipropionate monohydrate	SPRAY, METERED;NASAL	020469-001	Jun 26, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	⤷ Sign Up	⤷ Sign Up
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000	⤷ Sign Up	⤷ Sign Up
Schering	VANCERIL	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	017573-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017	⤷ 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
Glaxosmithkline	BECLOVENT	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	018153-001	Approved Prior to Jan 1, 1982	⤷ 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
China	105903107	用于吸入器的剂量计数器、吸入器及其轴 (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2005113044		⤷ Sign Up
Israel	247400	מוני מינון למשאפים, משאפים, ומוטות למשאפים (Dose counters for inhalers, inhalers and shafts thereof)	⤷ Sign Up
South Korea	20200116117	호흡 작동식 흡입기	⤷ Sign Up
South Africa	201307996	DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF	⤷ Sign Up
Hong Kong	1214990	鼻噴裝置 (NASAL SPRAY DEVICE)	⤷ Sign Up
United Kingdom	201702408		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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