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Last Updated: December 15, 2019

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VALISONE Drug Profile

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When do Valisone patents expire, and when can generic versions of Valisone launch?

Valisone is a drug marketed by Schering and is included in three NDAs.

The generic ingredient in VALISONE is betamethasone valerate. There are sixty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone valerate profile page.

US ANDA Litigation and Generic Entry Outlook for Valisone

A generic version of VALISONE was launched as betamethasone valerate by FOUGERA PHARMS INC on December 15th, 2019.

Summary for VALISONE
US Patents:0
Applicants:1
NDAs:3
Bulk Api Vendors: 71
Formulation / Manufacturing:see details
DailyMed Link:VALISONE at DailyMed
Drug patent expirations by year for VALISONE
Synonyms for VALISONE
.beta.-Corlan
.beta.-Methasone
.beta.-Methasone alcohol
(11.beta.,16.beta.)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
(11beta,16beta)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
(1R,2S,10S,11S,13S,14R,15S,17S)-1-fluoro-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,13,15-trimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-5-one
(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one
1,4-Pregnadiene-3,20-dione-9alpha-fluoro-16 beta-methyl-11beta,17alpha,21-triol
16-.beta.-Methyl-1,4-pregnadiene-9-.alpha.-fluoro-11-.beta.,17-.alpha.,21-triol-3,20-dione
16-beta-Methyl-1,4-pregnadiene-9-alpha-fluoro-11-beta,17-alpha,21-triol-3,20-dione
16beta-Methyl-1,4-pregnadiene-9alpha-fluoro-11beta,17alpha,21-triol-3,20-dione
20525-EP2272832A1
20525-EP2295409A1
20525-EP2298778A1
20525-EP2308562A2
20525-EP2314585A1
20525-EP2314590A1
20525-EP2371811A2
378-44-9
378-44-9,956901-32-9(XHCl)
378M449
4-08-00-03501 (Beilstein Handbook Reference)
9-.alpha.-Fluoro-11-.beta.,17-.alpha.,21-trihydroxy-16-.beta.-methylpregna-1,4-diene-3,20-dione
9-.alpha.-Fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methylpregna-1,4-diene-3,20-dione
9-.alpha.-Fluoro-16-.beta.-methyl-1,4-pregnadiene-11-.beta.,17-.alpha.,21-triol-3,20-dione
9-alpha-Fluoro-16-beta-methyl-1,4-pregnadiene-11-beta,17-alpha,21-triol-3,20-dione
9-alpha-Fluoro-16-beta-methylprednisolone
9-Fluoro-11-beta,17,21-trihydroxy-16-beta-methylpregna-1,4-diene-3,20-dione
9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione, (11.beta.,16.beta.) #
9-Fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione
9-Fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
9-Fluoro-16.beta.-methylprednisolone
9-fluoro-16beta-methyl-11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione
9-Fluoro-16beta-methylprednisolone
9.alpha.-Fluoro-16.beta.-methylprednisolone
9842X06Q6M
9alpha-Fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione
9alpha-Fluoro-11beta,17alpha,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
9alpha-Fluoro-16 beta-methyl-11beta,17alpha, 21-trihydroxy-1,4-pregnadiene-3,20-dione
9alpha-Fluoro-16 beta-methyl-prednisolone
9alpha-Fluoro-16beta-methyl-11beta,17alpha,21-trihydroxy-1,4-pregnadiene-3,20-dione
9alpha-Fluoro-16beta-methylprednisolone
AB0012192
AB1009527
AC1L1TT4
ACN-043339
AKOS008901360
AKOS015894863
API0001693
BCP02020
BCP9000393
BCPP000345
BDBM73823
Bebate
Becort
Bedifos
beta-Methasone
beta-Methasone alcohol
Betacorlan
Betacortril
Betadexamethasone
Betafluorene
Betamamallet
Betametasona
Betametasona [INN-Spanish]
Betametasone
Betametasone [DCIT]
betamethasone
Betamethasone (Celestone)
Betamethasone (JP17/USP/INN)
Betamethasone [USAN:BAN:INN:JAN]
Betamethasone [USAN:INN:BAN:JAN]
Betamethasone [USAN:USP:INN:BAN:JAN]
Betamethasone alcohol
Betamethasone Base
Betamethasone cream
Betamethasone Valearate
Betamethasone, >=98%
Betamethasone, 97%
Betamethasone, British Pharmacopoeia (BP) Reference Standard
Betamethasone, European Pharmacopoeia (EP) Reference Standard
Betamethasone, meets USP testing specifications
Betamethasone, pharmaceutical impurity standard, >=95.0% (HPLC)
Betamethasone, Pharmaceutical Secondary Standard; Certified Reference Material
Betamethasone, topical
Betamethasone, United States Pharmacopeia (USP) Reference Standard
Betamethasone, VETRANAL(TM), analytical standard
Betamethasonum
Betamethasonum [INN-Latin]
Betamethasonvalerat Mikron
Betamethazone
Betapredol
Betasolon
Betnelan
Betsolan
BIDD:PXR0047
BPBio1_000533
BRD-K39188321-001-03-9
BRN 3176546
BSPBio_000483
C06848
C22H29FO5
CAS-378-44-9
CCG-220362
Celestene
Celeston
Celestona
Celestone
Celestone Syrup and Tablets
Cellestoderm
CHEBI:3077
CHEMBL632
cid_9782
Cidoten
Corticosterone, 1-dehydro-9-fluoro-17-hydroxy-16.beta.-methyl-
Corticosterone, 1-dehydro-9-fluoro-17-hydroxy-16beta-methyl-
CS-1897
D00244
D1961
DB00443
Desacort-.beta.
Desacort-Beta
DSSTox_CID_2667
DSSTox_GSID_22667
DSSTox_RID_76681
DTXSID3022667
EBD2157848
EC 206-825-4
EINECS 206-825-4
Flubenisolone
FT-0622922
GTPL7061
HMS1569I05
HMS2096I05
HMS2233I08
HMS3713I05
Hormezon
HSDB 3015
HY-13570
KS-5302
Lotrisone
LS-118466
Luxiqo
Methazon
MFCD00062969
MLS000859943
MLS001066413
MLS001332616
MLS002153244
MolPort-003-845-025
NCGC00091019-08
NCGC00164401-01
NCGC00164401-02
NCGC00164401-03
NCGC00255195-01
NCS-39470
NSC 39470
NSC-39470
NSC39470
Prednisolone, 9-fluoro-16.beta.-methyl-
Prednisolone, 9-fluoro-16beta-methyl-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11.beta.,16.beta.)-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11beta,16beta)-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methyl-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-16beta-methyl-
Pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-16beta-methyl- (8CI)
Pregna-1,4-diene-3,20-dione, 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-
Prestwick_703
Prestwick0_000362
Prestwick1_000362
Prestwick2_000362
Prestwick3_000362
Rinderon
Rinderon (TN)
Rinderon A
s1500
SCH 4831
SCH-4831
SCHEMBL4565
SMP1_000043
SMR000058601
SPBio_002404
SR-01000780582
SR-01000780582-2
Tox21_112115
Tox21_112115_1
Tox21_301455
UNII-9842X06Q6M
UREBDLICKHMUKA-DVTGEIKXSA-N
Visubeta
W-106509
ZINC3876136

US Patents and Regulatory Information for VALISONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering VALISONE betamethasone valerate CREAM;TOPICAL 016322-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Schering VALISONE betamethasone valerate OINTMENT;TOPICAL 016740-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Schering VALISONE betamethasone valerate CREAM;TOPICAL 016322-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Schering VALISONE betamethasone valerate LOTION;TOPICAL 016932-001 Approved Prior to Jan 1, 1982 DISCN No No   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

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