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Last Updated: December 5, 2022

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 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.

Recent Clinical Trials for beclomethasone dipropionate

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

SponsorPhase
SOFAR S.p.A.Phase 1
Pharmactive Ilac Sanayi ve Tic A.S.Phase 1/Phase 2
Aurobindo Pharma LtdPhase 3

See all beclomethasone dipropionate clinical trials

Pharmacology for beclomethasone dipropionate
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm QNASL beclomethasone dipropionate AEROSOL, METERED;NASAL 202813-002 Dec 17, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Schering VANCENASE AQ beclomethasone dipropionate monohydrate SPRAY, METERED;NASAL 019589-001 Dec 23, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm QVAR 80 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-001 Sep 15, 2000 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-001 Aug 3, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Teva Branded Pharm QVAR 80 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-001 Sep 15, 2000 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline BECONASE beclomethasone dipropionate AEROSOL, METERED;NASAL 018584-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

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 See Plans and Pricing
Denmark 2514462 See Plans and Pricing
Mexico 2012012956 CONTADORES DE DOSIS PARA INHALADORES, INHALADORES Y FLECHAS DE LOS MISMOS. (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF.) See Plans and Pricing
Spain 2544501 See Plans and Pricing
Portugal 2502644 See Plans and Pricing
South Africa 201301938 NASAL SPRAY DEVICE See Plans and Pricing
Eurasian Patent Organization 023985 ИНГАЛЯТОР ДЛЯ ВДЫХАНИЯ ЛЕКАРСТВЕННЫХ ВЕЩЕСТВ И СПОСОБ СБОРКИ ИНГАЛЯТОРА (INHALER FOR INHALATION OF MEDICINAL SUBSTANCES AND METHOD FOR INHALER ASSEMBLING) See Plans and Pricing
>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.