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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, Precision Dermat, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent Pharma Inc, Watson Labs, Watson Labs Teva, Zydus Worldwide, Lederle, Rempex Pharms, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Medicis, Par Pharm, and Sun Pharm Industries, and is included in thirty-four NDAs. There are thirteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for minocycline hydrochloride

International Patents:	56
US Patents:	13
Tradenames:	7
Applicants:	27
NDAs:	34
Drug Master File Entries:	14
Suppliers / Packagers:	51
Bulk Api Vendors:	71
Clinical Trials:	178
Patent Applications:	2,652
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for minocycline hydrochloride
DailyMed Link:	minocycline hydrochloride at DailyMed

Pharmacology for minocycline hydrochloride

Ingredient-type	Tetracyclines
Drug Class	Tetracycline-class Drug

Medical Subject Heading (MeSH) Categories for minocycline hydrochloride

Anti-Bacterial Agents

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

[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-(4alpha,4aalpha,5aalpha,12aalpha)]-4,7-Bis(dimeth

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

AK144731

AKOS015951312

Arestin

Arestin (TN)

BC207859

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

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, Antibiotic for Culture Media Use Only

Minocycline hydrochloride, crystalline

Minocycline hydrochloride, European Pharmacopoeia (EP) Reference Standard

Minocycline Hydrochloride, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Minocycline hydrochloride, United States Pharmacopeia (USP) Reference Standard

Minocycline, Hydrochloride

Minomax

Minomycin

MLS002548863

MolPort-003-666-235

MolPort-042-652-589

Mynocine

Mynocine hydrochloride

NC00460

NCGC00096006-01

NCGC00178854-03

NCGC00255988-01

NSC 141993

NSC-757120

NSC757120

Periocline

Pharmakon1600-01500414

Prestwick_626

Q-201407

S051

s4226

SC-19210

SCHEMBL2537

SMR001906766

Solodyn

Solodyn (TN)

SPECTRUM1500414

ST24034766

Tox21_111250

Tox21_111250_1

Tox21_113183

Tox21_301590

Tri-mino

Tri-minocycline

UNII-0020414E5U

Vectrin

W-5076

Tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 45MG BASE	TABLET, EXTENDED RELEASE;ORAL
		EQ 135MG BASE	TABLET, EXTENDED RELEASE;ORAL
		EQ 115MG BASE	TABLET, EXTENDED RELEASE;ORAL

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	050808-002	May 8, 2006		DISCN	Yes	No
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010	AB	RX	Yes	No
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006		DISCN	Yes	No
Rempex Pharms	MINOCIN	minocycline hydrochloride	INJECTABLE;INJECTION	050444-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006		DISCN	Yes	No
Dr Reddys Labs Ltd	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TABLET;ORAL	065436-001	Dec 26, 2007	AB	RX	No	No
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-007	Aug 27, 2010	AB	RX	Yes	No

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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
Sun Pharm Inds Ltd	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012
Sun Pharm Inds Ltd	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006
Medicis	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006
Sun Pharm Inds Ltd	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012

Non-Orange Book US Patents for minocycline hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,744,179	Tetracycline compositions

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International Patents for minocycline hydrochloride

Country	Document Number	Estimated Expiration
Poland	2568987
World Intellectual Property Organization (WIPO)	2011143503
European Patent Office	2568987
Mexico	2012012993
Japan	2016145253
New Zealand	707329
Japan	2008543936