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ARESTIN Drug Profile

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Which patents cover Arestin, and when can generic versions of Arestin launch?

Arestin is a drug marketed by Orapharma and is included in one NDA. There are two patents protecting this drug.

This drug has sixteen patent family members in thirteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Arestin

A generic version of ARESTIN was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

Summary for ARESTIN

International Patents:	16
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	6
Patent Applications:	1,877
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ARESTIN
DailyMed Link:	ARESTIN at DailyMed

See drug prices for ARESTIN

Recent Clinical Trials for ARESTIN

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

Sponsor	Phase
University of Minnesota - Clinical and Translational Science Institute	Phase 4
Bausch Health Companies, INC.	Phase 4
University of California, San Francisco	N/A

See all ARESTIN clinical trials

Pharmacology for ARESTIN

Drug Class

Tetracycline-class Drug

Synonyms for ARESTIN

(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 (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

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

US Patents and Regulatory Information for ARESTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001		RX	Yes	Yes			Y
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781-001	Feb 16, 2001		RX	Yes	Yes			Y

International Patents for ARESTIN

Country	Patent Number	Estimated Expiration
Brazil	0308859
Japan	2005521467
Slovenia	2263596
Japan	4749672
Cyprus	1114425
World Intellectual Property Organization (WIPO)	03082139
Argentina	039205