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Last Updated: March 19, 2024

BECLOMETHASONE DIPROPIONATE - Generic Drug Details


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What are the generic drug 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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Beclomethasone dipropionate has three hundred and twenty-five 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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BECLOMETHASONE DIPROPIONATE
Generic Entry Dates for BECLOMETHASONE DIPROPIONATE*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION
Generic Entry Dates for BECLOMETHASONE DIPROPIONATE*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION
Generic Entry Dates for BECLOMETHASONE DIPROPIONATE*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
SGS S.A.Phase 1
Chiesi Farmaceutici S.p.A.Phase 1
SOFAR S.p.A.Phase 1

See all BECLOMETHASONE DIPROPIONATE clinical trials

Generic filers with tentative approvals for BECLOMETHASONE DIPROPIONATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.08MG/INHAEROSOL, METERED;INHALATION
⤷  Try a Trial⤷  Try a Trial0.04MG/INHAEROSOL, 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
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

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Norton Waterford QVAR REDIHALER beclomethasone dipropionate AEROSOL, METERED;INHALATION 207921-001 Aug 3, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline BECONASE beclomethasone dipropionate AEROSOL, METERED;NASAL 018584-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Teva Branded Pharm QVAR 40 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-002 Sep 15, 2000 ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm QVAR 80 beclomethasone dipropionate AEROSOL, METERED;INHALATION 020911-001 Sep 15, 2000 ⤷  Try a Trial ⤷  Try a Trial
Schering VANCENASE beclomethasone dipropionate AEROSOL, METERED;NASAL 018521-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BECLOMETHASONE DIPROPIONATE

Country Patent Number Title Estimated Expiration
European Patent Office 3517155 INHALATEUR ACTIONNÉ PAR LA RESPIRATION (BREATH ACTUATED INHALER) ⤷  Try a Trial
Mexico 2013003840 DISPOSITIVO DA ATOMIZADOR NASAL. (NASAL SPRAY DEVICE.) ⤷  Try a Trial
Eurasian Patent Organization 201690641 ИНКРЕМЕНТАЛЬНЫЙ СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА ОТМЕРЕННЫХ ДОЗ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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