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Last Updated: January 30, 2023

Betamethasone dipropionate - Generic Drug Details


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What are the generic sources for betamethasone dipropionate and what is the scope of freedom to operate?

Betamethasone dipropionate is the generic ingredient in thirteen branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Generics, Padagis Israel, Taro, Schering, Organon, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Akorn, Pai Holdings Pharm, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Pharmgen, Lupin Ltd, Cadila, Tasman Pharma, Taro Pharms, Primus Pharms, Leo Pharma As, MC2, Tolmar, Glenmark Pharms, and Merck Sharp Dohme, and is included in seventy-five NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Betamethasone dipropionate has seven patent family members in five countries.

There are thirteen drug master file entries for betamethasone dipropionate. Twenty-five suppliers are listed for this compound.

Drug Prices for betamethasone dipropionate

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Drug Sales Revenue Trends for betamethasone dipropionate

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Recent Clinical Trials for betamethasone dipropionate

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

SponsorPhase
Affiliated Hospital of Nantong UniversityN/A
Oticara Australia PTY LTDPhase 1
University of Alabama at BirminghamPhase 4

See all betamethasone dipropionate clinical trials

Pharmacology for betamethasone dipropionate
Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SERNIVO Topical Spray betamethasone dipropionate 0.05% 208079 1 2018-02-15

US Patents and Regulatory Information for betamethasone dipropionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms BETAMETHASONE DIPROPIONATE betamethasone dipropionate CREAM;TOPICAL 208885-001 Jan 11, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tolmar CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 201615-001 Jan 14, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Padagis Israel CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 212367-001 Sep 11, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pai Holdings Pharm BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 206389-001 Feb 13, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Perrigo New York BETAMETHASONE DIPROPIONATE betamethasone dipropionate CREAM;TOPICAL 074579-001 Nov 26, 1997 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alpharma Us Pharms BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION;TOPICAL 071085-001 Feb 3, 1987 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 betamethasone dipropionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon DIPROLENE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 019716-001 Aug 1, 1988 See Plans and Pricing See Plans and Pricing
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986 See Plans and Pricing See Plans and Pricing
Organon DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741-001 Jul 27, 1983 See Plans and Pricing See Plans and Pricing
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986 See Plans and Pricing See Plans and Pricing
Organon DIPROLENE AF betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019555-001 Apr 27, 1987 See Plans and Pricing See Plans and Pricing
Schering DIPROLENE betamethasone dipropionate GEL, AUGMENTED;TOPICAL 019408-002 Nov 22, 1991 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for betamethasone dipropionate

Country Patent Number Title Estimated Expiration
Denmark 2473161 See Plans and Pricing
Japan 2013503203 See Plans and Pricing
Japan 5833007 See Plans and Pricing
European Patent Office 3141246 See Plans and Pricing
Spain 2637447 See Plans and Pricing
European Patent Office 2473161 COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID) 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.