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Last Updated: March 19, 2024

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, Encube, Hikma, Alpharma Us Pharms, Fougera Pharms Inc, Padagis Us, Shree Hari Intl, Lupin Ltd, Tasman Pharma, Zydus Lifesciences, Primus Pharms, Glenmark Pharms Ltd, Leo Pharma As, MC2, Chartwell Rx, Glenmark Pharms, and Merck Sharp Dohme, and is included in seventy-six NDAs. There are seventeen 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-four 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
Oticara Australia PTY LTDPhase 2
Affiliated Hospital of Nantong UniversityN/A
Oticara Australia PTY LTDPhase 1

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
Primus Pharms SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079-001 Feb 5, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Schering DIPROSONE betamethasone dipropionate LOTION;TOPICAL 017781-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 202894-001 Oct 30, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon DIPROLENE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 019716-001 Aug 1, 1988 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 075673-001 May 29, 2001 AB RX No Yes ⤷  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 BETAMETHASONE DIPROPIONATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986 ⤷  Try a Trial ⤷  Try a Trial
Organon DIPROLENE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 019716-001 Aug 1, 1988 ⤷  Try a Trial ⤷  Try a Trial
Organon DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741-001 Jul 27, 1983 ⤷  Try a Trial ⤷  Try a Trial
Schering DIPROLENE betamethasone dipropionate GEL, AUGMENTED;TOPICAL 019408-002 Nov 22, 1991 ⤷  Try a Trial ⤷  Try a Trial
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for BETAMETHASONE DIPROPIONATE

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2011026076 ⤷  Try a Trial
Japan 5833007 ⤷  Try a Trial
European Patent Office 2473161 COMPOSITIONS TOPIQUES CONTENANT UN STÉROÏDE (TOPICAL FORMULATIONS COMPRISING A STEROID) ⤷  Try a Trial
Denmark 2473161 ⤷  Try a Trial
European Patent Office 3141246 ⤷  Try a Trial
>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.