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Last Updated: May 26, 2020

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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 freedom to operate?

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

Ivermectin has ninety-eight patent family members in twenty-nine countries.

There are five drug master file entries for ivermectin. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for ivermectin

See drug prices for ivermectin

Recent Clinical Trials for ivermectin

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

SponsorPhase
Manhiça Health Research Centre (CISM)Phase 2
The Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD)Phase 2
Chittagong Medical CollegePhase 2

See all ivermectin clinical trials

Recent Litigation for ivermectin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc.2019-02-19
Arbor Pharmaceuticals, LLC v. Teva Pharmaceuticals USA, Inc.2019-01-09
Arbor Pharmaceuticals, LLC v. Taro Pharmaceuticals U.S.A., Inc.2017-12-15

See all ivermectin litigation

Generic filers with tentative approvals for IVERMECTIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.5%LOTION;TOPICAL

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 ivermectin
Medical Subject Heading (MeSH) Categories for ivermectin
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'
(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
(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-6,10,11,14,15,17,17a,20,20a,20b-decahydro-2H,7H-spiro[11,15-methanofuro[4,3,
(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'-tetrahydropy
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
22,23-DIHYDROAVERMECTIN B1A; IVERMECTIN
288I867
5-O-demethyl-22,23-dihydroavermectin A1a
6-(butan-2-yl)-21',24'-dihydroxy-12'-({5-[(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[oxane-2,6'-tetracyclo[15.6.1.1?,?.0(2)?,(2)?]pe
70161-11-4
70288-86-7
71827-03-7
91Y2202OUW
AB00513813
AB00513813_04
AB00513813-02
AB00513813-03
AB01563172_01
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
BPBio1_000322
BRD-A48570745-001-01-1
BRD-K24652731-001-02-7
BRD-K85554912-001-08-9
BRN 4643153
BSPBio_000292
C48H74O14
C48H74O14 (B1a form)
CAS-71827-03-7
CCG-204778
CCG-213693
CCG-220156
CHEBI:63941
CHEBI:91732
CHEBI:94551
CHEMBL1699565
CHEMBL1876587
CHEMBL263291
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
HMS1568O14
HMS2089M09
HMS2091E11
HMS2095O14
HMS2233J07
HMS3262K07
HMS3712O14
I 8898
I1850
Ivermectin (IVM)
Ivermectin (MK-0933)
Ivermectin B1a
Ivermectin, Antibiotic for Culture Media Use Only
Ivermectin, British Pharmacopoeia (BP) Reference Standard
Ivermectin, European Pharmacopoeia (EP) Reference Standard
Ivermectin, Pharmaceutical Secondary Standard; Certified Reference Material
Ivermectin, United States Pharmacopeia (USP) Reference Standard
IVM
J10179
Lopac0_000693
LP00693
LSM-5397
MFCD00869511
MK-933
MK933
MLS001333247
MLS001333248
MLS002153248
NCGC00094047-01
NCGC00094047-02
NCGC00163233-01
NCGC00186639-01
NCGC00186639-03
NCGC00261378-01
NSC-755843
NSC755843
Pharmakon1600-01300027
Prestwick_516
Prestwick2_000156
Prestwick3_000156
Q-201262
Q27132923
Q27166389
s1351
SCHEMBL13259385
SCHEMBL312795
SMR000857211
SR-01000075941
SR-01000075941-1
SR-01000075941-6
SR-01000075941-7
SR-05000001905
SR-05000001905-1
SR-05000001905-2
SW219099-1
Tox21_112034
Tox21_500693
UNII-8883YP2R6D component AZSNMRSAGSSBNP-XPNPUAGNSA-N
UNII-91Y2202OUW
VA11120
ZINC238808778
ZINC252286706
ZINC253388066
ZINC253388068
ZINC253630390
ZINC301054281
Paragraph IV (Patent) Challenges for IVERMECTIN
Tradename Dosage Ingredient NDA Submissiondate
SKLICE LOTION;TOPICAL ivermectin 202736 2017-09-01
SOOLANTRA CREAM;TOPICAL ivermectin 206255 2016-12-30

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
Edenbridge Pharms IVERMECTIN ivermectin TABLET;ORAL 204154-001 Oct 24, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes   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 ivermectin

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

Supplementary Protection Certificates for ivermectin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 PA2015033 Lithuania   Start Trial PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 300756 Netherlands   Start Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504
1620113 15C0069 France   Start Trial PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113 CR 2015 00045 Denmark   Start Trial PRODUCT NAME: LVERMECTIN (22,23-DIHYDROAVERMECTIN B1 A + 22,23-DIHYDROAVERMECTIN B1 B); NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113 CA 2015 00045 Denmark   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
McKesson
Colorcon
Merck
Moodys

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 verification 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.