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Last Updated: October 25, 2020

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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 twelve branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Generics, Perrigo Israel, Taro, Schering, Merck Sharp Dohme, Savage Labs, Actavis Mid Atlantic, Cosette, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Hi Tech, Teligent Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, Lupin Ltd, Cadila, Taro Pharms, Encore Dermat, Leo Pharma As, MC2, Perrigo Uk Finco, Tolmar, and Glenmark Pharms, and is included in seventy-two NDAs. There are eighteen 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 sixty-six 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

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SponsorPhase
University of Alabama at BirminghamPhase 4
Eli Lilly and CompanyPhase 4
Cairo UniversityN/A

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Pharmacology for betamethasone dipropionate
Paragraph IV (Patent) Challenges for BETAMETHASONE DIPROPIONATE
Tradename Dosage Ingredient NDA Submissiondate
SERNIVO SPRAY;TOPICAL betamethasone dipropionate 208079 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
Alpharma Us Pharms BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION;TOPICAL 071085-001 Feb 3, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Tolmar CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 210765-001 May 11, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Schering DIPROSONE betamethasone dipropionate DISC;TOPICAL 017829-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmaderm BETAMETHASONE DIPROPIONATE betamethasone dipropionate LOTION;TOPICAL 070274-001 Aug 12, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Encore Dermat SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079-001 Feb 5, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Merck Sharp Dohme DIPROLENE betamethasone dipropionate LOTION, AUGMENTED;TOPICAL 019716-001 Aug 1, 1988   Start Trial   Start Trial
Merck Sharp Dohme DIPROLENE AF betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019555-001 Apr 27, 1987   Start Trial   Start Trial
Merck Sharp Dohme DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741-001 Jul 27, 1983   Start Trial   Start Trial
Schering DIPROLENE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019408-001 Jan 31, 1986   Start Trial   Start Trial
Schering DIPROLENE betamethasone dipropionate GEL, AUGMENTED;TOPICAL 019408-002 Nov 22, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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