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Ivermectin - Generic Drug Details
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What are the generic sources for ivermectin and what is the scope of patent protection?
Ivermectin
is the generic ingredient in four branded drugs marketed by Perrigo Uk Finco, Teva Pharms Usa, Galderma Labs Lp, Taro, Arbor Pharms Llc, Edenbridge Pharms, and Merck Sharp Dohme, and is included in seven 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 one hundred and one patent family members in twenty-nine countries.
There are five drug master file entries for ivermectin. Eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ivermectin
International Patents: | 101 |
US Patents: | 13 |
Tradenames: | 4 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 5 |
Suppliers / Packagers: | 8 |
Bulk Api Vendors: | 54 |
Clinical Trials: | 140 |
Patent Applications: | 7,280 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ivermectin |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ivermectin |
DailyMed Link: | ivermectin at DailyMed |
Recent Clinical Trials for ivermectin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Public Health Laboratory Ivo de Carneri, Chake Chake, Pemba, Zanzibar, Tanzania | Phase 2/Phase 3 |
Coordinación de Investigación en Salud, Mexico | Phase 3 |
Gilberto Cruz Arteaga | Phase 3 |
Generic filers with tentative approvals for IVERMECTIN
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 0.5% | 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
Drug Class | Antiparasitic Pediculicide |
Medical Subject Heading (MeSH) Categories for ivermectin
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arbor Pharms Llc | SKLICE | ivermectin | LOTION;TOPICAL | 202736-001 | Feb 7, 2012 | OTC | Yes | Yes | Start Trial | Start Trial | Y | 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 | |||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 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 | ||
Arbor Pharms Llc | SKLICE | ivermectin | LOTION;TOPICAL | 202736-001 | Feb 7, 2012 | OTC | 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 | ||
>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 |
---|---|---|---|---|---|---|---|
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | Start Trial | Start Trial |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ivermectin
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 102231948 | Start Trial |
World Intellectual Property Organization (WIPO) | 2004093886 | Start Trial |
Russian Federation | 2633481 | Start Trial |
Australia | 2004231323 | Start Trial |
France | 2854074 | Start Trial |
South Korea | 101291824 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ivermectin
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1620113 | C 2015 036 | Romania | Start Trial | PRODUCT NAME: IVERMECTINA; NATIONAL AUTHORISATION NUMBER: RO7674/2015/01, RO7674/2015/02, RO7674/2015/03, RO7674/2015/04, RO7674/2015/05; DATE OF NATIONAL AUTHORISATION: 20150526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MALTA MA117/01101; DATE OF FIRST AUTHORISATION IN EEA: 20150402 |
1620113 | PA2015033,C1620113 | Lithuania | Start Trial | PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402 |
1620113 | 15C0069 | France | Start Trial | PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402 |
1620113 | 92915 | Luxembourg | Start Trial | PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402 |
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 | C300756 | Netherlands | Start Trial | PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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