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Generated: July 21, 2017
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 Arbor Pharms Llc, Merck Sharp Dohme, Edenbridge Pharms, and Galderma Labs Lp, and is included in four NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 4 |
| Patents: | 15 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: see list | 5 |
| Suppliers / Packagers: see list | 7 |
| Bulk Api Vendors: see list | 50 |
| Clinical Trials: see list | 59 |
| Patent Applications: see list | 122 |
| Therapeutic Class: | Antiparasitics |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | ivermectin at DailyMed |
| Drug Class | Antiparasitic Pediculicide |
| 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 | RX | Yes | Yes | 8,791,153 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | 8,815,816 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | 5,952,372 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | 7,550,440 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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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 | ► Subscribe | |||||||||||||||||||||||||||
| 8,624,678 | Output stage of a power amplifier having a switched-bulk biasing and adaptive biasing | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| South Africa | 200507346 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 516037 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | I474841 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2016526572 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2012507545 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015 00045 | Denmark | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 0150035 00175 | Estonia | ► Subscribe | PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015 | ||||||||||||||||||||||||||
| /2015 | Austria | ► Subscribe | PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402 | ||||||||||||||||||||||||||
| 00756 | Netherlands | ► Subscribe | PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402 | ||||||||||||||||||||||||||
| C0069 | France | ► Subscribe | PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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