Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Dow
Johnson and Johnson
AstraZeneca
Express Scripts

Last Updated: December 5, 2019

DrugPatentWatch Database Preview

Minocycline hydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Minocycline hydrochloride is the generic ingredient in seven branded drugs marketed by Sun Pharm Inds Inc, Cnty Line Pharms, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, 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 Labs Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Medicis, Dr Reddys Labs Ltd, Par Pharm, and Sun Pharm Industries, and is included in thirty-five 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. Forty-nine suppliers are listed for this compound. There are five tentative approvals for this compound.

Recent Clinical Trials for minocycline hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Riyadh Elm UniversityN/A
Dow University of Health SciencesPhase 1/Phase 2
Sun Yat-sen UniversityPhase 2

See all minocycline hydrochloride clinical trials

Recent Litigation for minocycline hydrochloride

Identify potential future generic entrants

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 minocycline hydrochloride litigation

Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 105MG BASETablet, Extended Release; Oral
  Start Trial  Start TrialEQ 80MG BASETablet, Extended Release; Oral
  Start Trial  Start TrialEQ 55MG 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.

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
Paragraph IV (Patent) Challenges for MINOCYCLINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-13
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-02
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-10-27
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2009-11-19

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
Alkem Labs Ltd MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 204453-002 Sep 28, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride CAPSULE;ORAL 090867-001 May 13, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms MINOCYCLINE HYDROCHLORIDE minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 203553-001 Nov 16, 2017 AB RX 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

Expired US Patents for minocycline hydrochloride

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
Sun Pharm Inds Inc XIMINO minocycline hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 201922-001 Jul 11, 2012   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Boehringer Ingelheim
Moodys
McKesson
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.