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Last Updated: April 2, 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 eleven branded drugs marketed by Anda Repository, Fougera Pharms, Glenmark Generics, Perrigo Israel, Taro, Schering, Merck Sharp Dohme, Savage Labs, Acp Nimble, Actavis Mid Atlantic, Perrigo New York, Pharmaderm, Teva, Zydus Pharms, Hi Tech, Teligent Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, Lupin Ltd, Encore Dermat, Leo Pharma As, Perrigo Uk Finco, Tolmar, and Glenmark Pharms, and is included in sixty-seven NDAs. There are twelve 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-three 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
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)Phase 1
Celgene CorporationPhase 4

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Recent Litigation for betamethasone dipropionate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Promius Pharma LLC v. Perrigo UK FINCO Limited Partnership2018-05-22

See all betamethasone dipropionate litigation

Pharmacology for betamethasone dipropionate
Synonyms for betamethasone dipropionate
.beta.-Methasone 17,21-dipropionate
(11-beta,16-beta)-9-Chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
(11.beta.,16.beta.)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
(11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate
(8S,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-(propionyloxy)acetyl)-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl propionate
(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-(2-(propionyloxy)acetyl)-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthr
[2-(9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl)-2-oxoethyl] propanoate
[2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate
2-((2S,10S,11S,13S,15S,17S,1R,14R)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o xoethyl propanoate
5593-20-4
593B204
826Y60901U
9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate
9-Fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl propionate #
9-Fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl dipropanoate
9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate)
9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate
9alpha-Fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-Dipropionate
9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene- 17,21-diyl dipropionate
9alpha-Fluoro-16beta-methyl-11beta,17alpha,21-trihydroxy-1,4-pregnadiene-3,20-dione 17,21-dipropionate
AB01274713_02
AB01274713-01
AB01275498-01
AB2000220
AC-2161
AKOS015960446
AKOS015969733
AKOS025312304
AKOS037482518
Alphatrex
API0001696
AS-13826
B3166
BDBM50421892
Beloderm
beta-Methasone 17,21-dipropionate
Betamethasone 17,21-dipropionate
BETAMETHASONE DIPROP
betamethasone dipropionat
Betamethasone Dipropionate (Diprolene)
Betamethasone dipropionate (JP17/USP)
Betamethasone dipropionate [USAN:BAN:JAN]
Betamethasone dipropionate [USAN:USP:JAN]
betamethasone propionate
Betamethasone-17,21-dipropionate
Betamethasone-Dipropionate(Diprolene)
BRD-K58148589-001-03-6
BRN 3638108
C-22966
C28H37FO7
CAS-5593-20-4
CC-24614
CHEBI:31276
CHEMBL1200384
CHEMBL1449610
CIWBQSYVNNPZIQ-GXPAWERTSA-N
CIWBQSYVNNPZIQ-UHFFFAOYSA-N
CIWBQSYVNNPZIQ-XYWKZLDCSA-N
component of Alphatrex (Salt/Mix)
component of Betasone (Salt/Mix)
CS-7549
D01637
Diproderm
Diprolene
Diprolene (TN)
Diprolene AF
Diprosis
Diprosone
Diprospan;Diprolene;Diprosone;Diprolene AF;Diprolene
DSSTox_CID_2672
DSSTox_GSID_22672
DSSTox_RID_76683
DTXSID2022672
EBD2157850
EINECS 227-005-2
en-17-yl propionate
FT-0082786
HMS2090K11
HY-13571
J10388
KS-5303
LS-118474
Maxivate
MCULE-9093329990
MFCD00133140
NCGC00159360-02
NCGC00159443-01
NCGC00159443-02
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-,17,21-dipropionate
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)
Pregna-1,4-diene-3,20-dione,9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11b,16b)-
Psorion
Q4897349
Rinderon DP
Rinderon-DP (TN)
S 3440
S-3440
s1688
SC-15701
Sch 11460
Sch-11460
SCHEMBL4566
SCHEMBL7519
Sernivo
Sernivo (TN)
ST024761
STL451053
Tox21_113343
UNII-826Y60901U
ZINC4212137
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
Schering DIPROSONE betamethasone dipropionate OINTMENT;TOPICAL 017691-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Taro BETAMETHASONE DIPROPIONATE betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 076543-001 Dec 9, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Encore Dermat SERNIVO betamethasone dipropionate SPRAY;TOPICAL 208079-001 Feb 5, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Schering DIPROSONE betamethasone dipropionate LOTION;TOPICAL 017781-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glenmark Pharms CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 202894-001 Oct 30, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741-001 Jul 27, 1983 AB RX Yes Yes   Start Trial   Start Trial   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 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
Merck Sharp Dohme DIPROLENE AF betamethasone dipropionate CREAM, AUGMENTED;TOPICAL 019555-001 Apr 27, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Merck
Express Scripts
Johnson and Johnson
AstraZeneca

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