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Last Updated: October 19, 2019

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SOLODYN Drug Profile

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When do Solodyn patents expire, and what generic alternatives are available?

Solodyn is a drug marketed by Medicis and is included in one NDA. There are eight patents protecting this drug and four Paragraph IV challenges.

This drug has thirteen patent family members in ten countries.

The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Drug patent expirations by year for SOLODYN
Drug Prices for SOLODYN

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Drug Sales Revenue Trends for SOLODYN

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Recent Clinical Trials for SOLODYN

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SponsorPhase
University of WashingtonPhase 2
Indiana UniversityPhase 2
University of MichiganPhase 2

See all SOLODYN clinical trials

Recent Litigation for SOLODYN

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District Court Litigation
Case NameDate
Apotex Inc. v. Wyeth LLC2015-07-29
Medicis Pharmaceutical Corporation v. Alkem Laboratories Ltd.2012-12-05
Medicis Pharmaceutical Corporation v. Zydus Pharmaceuticals USA Inc.2012-06-04

See all SOLODYN litigation

Pharmacology for SOLODYN
Synonyms for SOLODYN
(2E,4S,4aR,5aS,12aR)-2-(amino-hydroxy-methylidene)-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3 ,12-trione
(2E,4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione
(2E,4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione hydrochloride
(2Z,4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione
(2Z,4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione hydrochloride
(4S-(4alpha,4aalpha,5aalpha,12aalpha))-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide monohydrochloride
(4S,12aS,4aS,5aR)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide Hydrochloride
(4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione
(4S,4AS,5AR,12AS)-4,7-BIS(DIMETHYLAMINO)-3,10,12,12A-TETRAHYDROXY-1,11-DIOXO-1,4,4A,5,5A,6,11,12A-OCTAHYDROTETRACENE-2-CARBOXAMIDE
(4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide hydrochloride
(4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide
(minocycline)
[4S-(4?,4a?,5a?,12a?)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a,tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide
[4S-(4|A,4a|A,5a|A,12a|A)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydro-1,11-dioxo-2-naphthacenecarboxamide Hydrochloride
[4S-(4|A,4a|A,5a|A,12a|A)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide monohydrochloride
[4S-(4a,4aa,5aa,12aa)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a,tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide
[4S-(4alpha,4aalpha,5aalpha,12aalpha)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide monohydrochloride
0020414E5U
10118-90-8
10118-90-8 (base)
10118-90-8 (Parent)
1071702-75-4
1071761-03-9
11006-27-2
1236362-29-0
13614-98-7
13614-98-7 (mono-hydrochloride)
1371-EP2269978A2
1371-EP2269985A2
1371-EP2269991A2
1371-EP2272832A1
1371-EP2284150A2
1371-EP2284151A2
1371-EP2284152A2
1371-EP2284153A2
1371-EP2284155A2
1371-EP2284156A2
1371-EP2284164A2
1371-EP2287140A2
1371-EP2287148A2
1371-EP2287150A2
1371-EP2289871A1
1371-EP2292590A2
1371-EP2292612A2
1371-EP2295402A2
1371-EP2295419A2
1371-EP2295426A1
1371-EP2295427A1
1371-EP2298732A1
1371-EP2301534A1
1371-EP2301912A2
1371-EP2301913A1
1371-EP2301914A1
1371-EP2301916A2
1371-EP2305637A2
1371-EP2308832A1
1371-EP2308863A1
1371-EP2311451A1
1371-EP2311796A1
1371-EP2311797A1
1371-EP2311798A1
1371-EP2311799A1
1371-EP2316450A1
146440-73-5
150231-24-6
17175-40-5
18M908
2-Naphthacenecarboxamide, 4,7- bis(dimethylamino)-1,4,4a,5,5a,6,11,12a- octahydro-3,10,12,12a-tetrahydroxy-1,11dioxo-, monohydrochloride, [4S-(4alpha,4aalpha,5aalpha,12aalpha)]
2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S-(4alpha,4aalpha,5aalpha,12aalpha))-
2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S,4aS,5aR,12aS)-
2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, monohydrochloride
2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, monohydrochloride, (4S-(4alpha,4aalpha,5aalpha,12aalpha))-
24058-90-0
4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide
4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride
614M987
7-Dimethylamino-6-demethyl-6-deoxytetracycline
7-Dimethylamino-6-demethyl-6-deoxytetracycline, HCl
AB00053501_04
AB00053501_05
AB00053501-03
AB1009463
AC-22362
AC-30184
AC1L2NSN
AC1NQXWM
AC1NQY0N
AC1NSG07
AC1NSG0A
Acnez
AJ-65483
Akamin
Aknemin
AKOS015951312
AKOS015969674
Alti-Minocycline
AM20090714
API0003397
Apo-Minocycline
Arestin
Arestin (TN)
BC207859
BCBcMAP01_000027
BCP06597
BCP9000928
BDBM50103599
Borymycin
BRN 3077644
BSPBio_002035
C07225
C23H27N3O7
C23H27N3O7.HCl
C23H28ClN3O7
CAS-10118-90-8
CAS-13614-98-7
CCG-40107
CHEBI:50694
CHEBI:50697
CHEMBL1200881
CHEMBL1434
CHEMBL259172
CL 59806
CS-1256
D00850
D05045
DB01017
DivK1c_000450
DSSTox_CID_24545
DSSTox_CID_25033
DSSTox_GSID_44545
DSSTox_GSID_45033
DSSTox_RID_80306
DSSTox_RID_80650
DTXSID1045033
DTXSID8044545
DYKFCLLONBREIL-KVUCHLLUSA-N
Dynacin
Dynacin (TN)
EINECS 237-099-7
FT-0082736
FT-0601821
FT-0628949
FXFM-244
FYY3R43WGO
Gen-Minocycline
GLMUAFMGXXHGLU-VQAITOIOSA-N
HMS1568P12
HMS2090D03
HSDB 3130
HY-17412
IDI1_000450
J-500789
J10198
KB-274624
KBio1_000450
KBio2_001447
KBio2_004015
KBio2_006583
KBio3_001535
KBioGR_000583
KBioSS_001447
Klinomycin
KS-00000XT8
KSC-12-231B
KUC106429N
Lactoferrin B & Minocycline
Lactoferrin H & Minocycline
Lederderm
LMPK07000002
ls-007
LS-91518
LS-93850
LS-93852
M2288
MFCD00083669
MINO
Mino-Tabs
Minociclina
Minociclina [INN-Spanish]
minociclinum
Minocin
Minocin (Hydrochloride)
Minocin (TN)
Minocline
Minocyclin
minocycline
Minocycline (hydrochloride)
Minocycline (USAN/INN)
Minocycline [USAN:BAN:INN]
Minocycline [USAN:INN:BAN]
Minocycline chloride
Minocycline HCl
MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochloride (internal use)
Minocycline hydrochloride (JP17/USP)
Minocycline hydrochloride [USAN:JAN]
Minocycline hydrochloride [USP:JAN]
Minocycline hydrochloride, 97%
Minocycline hydrochloride, Antibiotic for Culture Media Use Only
Minocycline hydrochloride, crystalline
Minocycline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Minocycline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Minocycline hydrochloride, United States Pharmacopeia (USP) Reference Standard
Minocycline Monohydrochloride
Minocycline, HCl
Minocycline, Hydrochloride
Minocyclinhydrochlorid
Minocyclinum
Minocyclinum [INN-Latin]
Minocyn
Minoderm
Minomax
Minomycin
Minomycin chloride
minomycin hydrochloride
Minoz
MIY
MLS002548863
MolPort-003-666-235
MolPort-020-005-814
MolPort-042-652-589
Mynocine
Mynocine hydrochloride
NC00460
NCGC00096006-01
NCGC00178854-01
NCGC00178854-03
NCGC00183044-01
NCGC00188954-01
NCGC00255988-01
NINDS_000450
Novo-Minocycline
NSC-757120
NSC141993
NSC757120
Periocline
Pharmakon1600-01500414
Prestwick_626
Prestwick0_000315
Prestwick1_000315
Prestwick2_000315
Q-201407
S051
s4226
SBI-0051449.P003
SC-19210
SCHEMBL16681149
SCHEMBL24315
SCHEMBL2537
SCHEMBL4042
Sebomin
SMP1_000191
SMR001906766
Solodyn (TN)
SPBio_000974
SPBio_002529
Spectrum_000967
SPECTRUM1500414
Spectrum2_001047
Spectrum3_000508
Spectrum4_000062
Spectrum5_001293
SR-01000075625
SR-01000075625-1
SR-05000001675
SR-05000001675-3
ST24034766
Tox21_111250
Tox21_111250_1
Tox21_113183
Tox21_113643
Tox21_301590
Tri-mino
Tri-minocycline
UNII-0020414E5U
UNII-FYY3R43WGO
Vectrin
Vectrin (Hydrochloride)
W-5076
Ximino
ZINC100409820
ZINC14879992
ZINC4019704

US Patents and Regulatory Information for SOLODYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No   Start Trial   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 DISCN Yes 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

Expired US Patents for SOLODYN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 Aug 27, 2010   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SOLODYN
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablet 55 mg and 80 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablet 105 rng ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablets 65 mg and 115 mg ➤ Subscribe   Start Trial
➤ Subscribe Extended-release Tablet 45 mg, 90 mg and 135 mg ➤ Subscribe   Start Trial

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