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Generated: September 17, 2019

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Minocycline hydrochloride - Generic Drug Details

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What are the generic sources for minocycline hydrochloride and what is the scope of minocycline hydrochloride freedom to operate?

Minocycline hydrochloride is the generic ingredient in seven branded drugs marketed by Sun Pharm Inds Ltd, Cnty Line Pharms, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex Pharms, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Zydus Pharms, Epi Hlth, Medicis, Dr Reddys Labs Ltd, Par Pharm, and Sun Pharm Industries, and is included in thirty-four NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has fifty-nine patent family members in twenty-six countries.

There are fifteen drug master file entries for minocycline hydrochloride. Fifty-four suppliers are listed for this compound. There are seven tentative approvals for this compound.

Pharmacology for minocycline hydrochloride
Medical Subject Heading (MeSH) Categories for minocycline hydrochloride
Synonyms for minocycline hydrochloride
(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 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)-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-(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 (base)
10118-90-8 (Parent)
1071702-75-4
11006-27-2
1236362-29-0
13614-98-7
150231-24-6
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-, 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))-
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, HCl
AB1009463
AC-22362
AC1NQY0N
AC1NSG07
Acnez
AKOS015951312
Arestin
Arestin (TN)
BC207859
BCP06597
C23H27N3O7.HCl
C23H28ClN3O7
CAS-13614-98-7
CCG-40107
CHEBI:50697
CHEMBL1200881
CS-1256
D00850
DSSTox_CID_24545
DSSTox_GSID_44545
DSSTox_RID_80306
DTXSID8044545
Dynacin
Dynacin (TN)
EINECS 237-099-7
FT-0082736
FT-0601821
FXFM-244
GLMUAFMGXXHGLU-VQAITOIOSA-N
HMS1568P12
HY-17412
J10198
KB-274624
Klinomycin
KS-00000XT8
Lederderm
LS-91518
LS-93852
M2288
MFCD00083669
MINO
Minocin
Minocin (TN)
Minocycline (hydrochloride)
Minocycline chloride
Minocycline HCl
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, HCl
Minocycline, Hydrochloride
Minocyclinhydrochlorid
Minomax
Minomycin
Minomycin chloride
minomycin hydrochloride
MLS002548863
MolPort-003-666-235
MolPort-042-652-589
Mynocine
Mynocine hydrochloride
NC00460
NCGC00096006-01
NCGC00178854-03
NCGC00255988-01
NSC-757120
NSC757120
Periocline
Pharmakon1600-01500414
Prestwick_626
Q-201407
S051
s4226
SC-19210
SCHEMBL2537
SMR001906766
Solodyn
Solodyn (TN)
SPECTRUM1500414
SR-01000075625
SR-01000075625-1
ST24034766
Tox21_111250
Tox21_111250_1
Tox21_113183
Tox21_301590
Tri-mino
Tri-minocycline
UNII-0020414E5U
Vectrin
W-5076
Ximino
Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 135MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign UpEQ 115MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign UpEQ 105MG BASETABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for minocycline hydrochloride

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 050808-004 Jul 23, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Triax Pharms MINOCIN minocycline hydrochloride CAPSULE;ORAL 050315-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 090422-001 Aug 13, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 Aug 27, 2010 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
>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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Expired US Patents for minocycline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009 ➤ Sign Up ➤ Sign Up
Sun Pharm Inds Ltd XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-005 Jul 11, 2012 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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US Department of Justice
US Army
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Queensland Health
QuintilesIMS

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