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Ivermectin - Generic Drug Details

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. Eight 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:	8
Bulk Api Vendors:	57
Clinical Trials:	67
Patent Applications:	164
Formulation / Manufacturing:	see details
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

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Edenbridge Pharms	IVERMECTIN	ivermectin	TABLET;ORAL	204154-001	Oct 24, 2014	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ 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 ivermectin

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Non-Orange Book US Patents for ivermectin

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.

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Patent No.	Title	Estimated Patent Expiration
8,598,129	Topical application of ivermectin for the treatment of dermatological conditions/afflictions	➤ Sign Up
8,624,678	Output stage of a power amplifier having a switched-bulk biasing and adaptive biasing	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

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International Patents for ivermectin

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Country	Document Number	Estimated Expiration
Hong Kong	1133991	➤ Sign Up
European Patent Office	2155190	➤ Sign Up
Russian Federation	2016103715	➤ Sign Up
Chile	2016000008	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ivermectin

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2015	Austria	➤ Sign Up	PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
0756	Netherlands	➤ Sign Up	PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504
0150035 00175	Estonia	➤ Sign Up	PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
2015 00045	Denmark	➤ Sign Up	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description