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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. 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: | 64 |
| Clinical Trials: | 67 |
| Patent Applications: | 165 |
| 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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | STROMECTOL | ivermectin | TABLET;ORAL | 050742-001 | Nov 22, 1996 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Arbor Pharms Llc | SKLICE | ivermectin | LOTION;TOPICAL | 202736-001 | Feb 7, 2012 | RX | Yes | Yes | ➤ 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 | |||
| Edenbridge Pharms | IVERMECTIN | ivermectin | TABLET;ORAL | 204154-001 | Oct 24, 2014 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ 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
| 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.
| 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
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2350333 | ➤ Sign Up |
| South Korea | 101291824 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2015006305 | ➤ Sign Up |
| Japan | 5694944 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for ivermectin
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 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 |
| 915 | Luxembourg | ➤ Sign Up | PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402 |
| 2015000079 | Germany | ➤ Sign Up | 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 |
| C0069 | France | ➤ Sign Up | PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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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 verifification 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.
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