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Ivermectin - Generic Drug Details

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What are the generic drug sources for ivermectin and what is the scope of ivermectin freedom to operate?

Ivermectin is the generic ingredient in four branded drugs marketed by Galderma Labs Lp, Arbor Pharms Llc, Edenbridge Pharms, and Merck Sharp Dohme, and is included in four NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ivermectin has eighty-four patent family members in twenty-eight countries.

There are five drug master file entries for ivermectin. Seven suppliers are listed for this compound.

Summary for ivermectin

International Patents:	84
US Patents:	15
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	5
Suppliers / Packagers:	7
Bulk Api Vendors:	62
Clinical Trials:	81
Patent Applications:	167
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ivermectin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ivermectin
DailyMed Link:	ivermectin at DailyMed

Pharmacology for ivermectin

Drug Class

Antiparasitic Pediculicide

Medical Subject Heading (MeSH) Categories for ivermectin

Antiparasitic Agents

Insecticides

Synonyms for ivermectin

(1'R,2R,4'S,10'E,14'E,16'E,21'R)-6-(butan-2-yl)-21',24'-dihydroxy-12'-{[(2R,4S,6S)-5-{[(2S,4S,6S)-5-hydroxy-4-methoxy-6-methyloxan-2-yl]oxy}-4-methoxy-6-methyloxan-2-yl]oxy}-5,11',13',22'-tetramethyl-3',7',19'-trioxaspiro[oxa

(2ae,4e,5's,6s,6'r,7s,8e,11r,13r,15s,17ar,20r,20ar,20bs)-6'-[(2s)-Butan-2-Yl]-20,20b-Dihydroxy-5',6,8,19-Tetramethyl-17-Oxo-3',4',5',6,6',10,11,14,15,17,17a,20,20a,20b-Tetradecahydro-2h,7h-Spiro[11,15-Methanofuro[4,3,2-Pq][2,

(2R,5'S,6'R)-dihydroxy-[(2R,4S,5S,6S)-5-[(2S,4S,5S,6S)-5-hydroxy-4-methoxy-6-methyl-tetrahydropyran-2-yl]oxy-4-methoxy-6-methyl-tetrahydropyran-2-yl]oxy-5'-tetramethyl-6'-[(1S)-1-methylpropyl]spiro[[?]-2,2'-tetrahydropyran]on

(Unlabeled)Ivermectin-d2

116522-39-5

123022-60-6

139645-33-3

22,23-Dihydro C-076B1

22,23-Dihydro-5-O-demethylavermectin A1a

22,23-Dihydroavermectin B(1)a

22,23-Dihydroavermectin B1|||Heartgard 30|||Ivomec|||Ivosint|||Mectizan|||Stromectol|||Uvemec|||Vermic|||Zimecterin

22,23-Dihydroavermectin B1a

288I867

5-O-demethyl-22,23-dihydroavermectin A1a

70161-11-4

70288-86-7

71827-03-7

73910-57-3

91Y2202OUW

AB00513813

AB00513813_04

AB00513813-02

AB00513813-03

AB01563172_01

AC1MJ4GR

AC1N7O27

AKOS015969666

AKOS027470116

AS-14167

Avermectin A1a, 22,23-dihydro-5-O-demethyl-

Avermectin A1a, 5-O-demethyl-22,23-dihydro-

avermectin H2B1a

AZSNMRSAGSSBNP-XPNPUAGNSA-N

BDBM50409816

Bio-0055

BPBio1_000322

BRD-A48570745-001-01-1

BRD-K24652731-001-02-7

BRN 4643153

BSPBio_000292

C48H74O14 (B1a form)

CA011349

CAS-71827-03-7

CCG-204778

CCG-213693

CCG-220156

CHEBI:63941

CHEBI:91732

CHEBI:94551

CHEMBL1699565

CHEMBL1876587

CHEMBL263291

D09YHJ

dihydro avermectin Bla

Dihydroavermectin B1a

DSSTox_CID_3181

DSSTox_GSID_23181

DSSTox_RID_76909

DTXSID8023181

EINECS 276-046-2

EU-0100693

FT-0082656

GTPL2373

H2B1a

Heartgard 30

HMS1568O14

HMS2089M09

HMS2091E11

HMS2095O14

HMS2233J07

HMS3262K07

I 8898

I1850

Ivermectin (MK-0933)

Ivermectin B1a

Ivermectin-d2

Ivermectin, Antibiotic for Culture Media Use Only

Ivermectin, European Pharmacopoeia (EP) Reference Standard

Ivermectin, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Ivermectin, United States Pharmacopeia (USP) Reference Standard

IvermectinB1a

Ivexterm (TN)

IVM

Ivosint

J10179

Lopac0_000693

LP00693

Mectizan (TN)

MK-933

MLS001333247

MLS001333248

MLS002153248

MolPort-006-394-715

MolPort-020-015-936

MolPort-044-878-307

NCGC00094047-01

NCGC00094047-02

NCGC00163233-01

NCGC00186639-01

NCGC00261378-01

NSC-755843

NSC755843

Pharmakon1600-01300027

Prestwick_516

Prestwick2_000156

Prestwick3_000156

Q-201262

RL04692

s1351

SCHEMBL13259385

SCHEMBL17212450

SCHEMBL312795

Sklice

SMR000857211

Soolantra

SR-01000075941

SR-01000075941-1

Stromectol (TN)

Tox21_112034

Tox21_500693

UNII-8883YP2R6D component AZSNMRSAGSSBNP-XPNPUAGNSA-N

UNII-91Y2202OUW

VA11120

ZINC238808778

ZINC252286706

ZINC253630390

ZINC301054281

US Patents and Regulatory Information for ivermectin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014		RX	Yes	Yes
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014		RX	Yes	Yes			Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014		RX	Yes	Yes			Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014		RX	Yes	Yes			Y
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012		RX	Yes	Yes			Y
Merck Sharp Dohme	STROMECTOL	ivermectin	TABLET;ORAL	050742-001	Nov 22, 1996		DISCN	No	No

Expired US Patents for ivermectin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012

International Patents for ivermectin

Country	Document Number	Estimated Expiration
Australia	2014287422
Russian Federation	2350333
Spain	2653259
Canada	2916668
European Patent Office	3019173
Japan	5711867

Supplementary Protection Certificates for ivermectin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015000079	Germany		PRODUCT NAME: IVERMECTIN ZU SEINER VERWENDUNG FUER DIE BEHANDLUNG VON ROSAZEA; NAT. REGISTRATION NO/DATE: 92429.00.00 20150429; FIRST REGISTRATION: MALTA MA 117/01101 20150402
2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
/2015	Austria		PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
C0069	France		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
0756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504