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Serving 500+ biopharmaceutical companies globally:

Fuji
QuintilesIMS
Express Scripts
Boehringer Ingelheim
Harvard Business School
US Department of Justice
Novartis
Merck
Accenture
Healthtrust

Generated: September 23, 2017

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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 Arbor Pharms Llc, Merck Sharp Dohme, Edenbridge Pharms, and Galderma Labs Lp, and is included in four NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ivermectin has seventy-three patent family members in twenty-seven countries.

There are five drug master file entries for ivermectin. Eight suppliers are listed for this compound.

Summary for Generic Name: ivermectin

Tradenames:4
Patents:14
Applicants:4
NDAs:4
Drug Master File Entries: see list5
Suppliers / Packagers: see list8
Bulk Api Vendors: see list50
Clinical Trials: see list63
Patent Applications: see list122
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ivermectin at DailyMed

Pharmacology for Ingredient: 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;TOPICAL202736-001Feb 7, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
STROMECTOL
ivermectin
TABLET;ORAL050742-001Nov 22, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Edenbridge Pharms
IVERMECTIN
ivermectin
TABLET;ORAL204154-001Oct 24, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Arbor Pharms Llc
SKLICE
ivermectin
LOTION;TOPICAL202736-001Feb 7, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,598,129Topical application of ivermectin for the treatment of dermatological conditions/afflictions► Subscribe
8,624,678Output 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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International Patent Family for Ingredient: ivermectin

Country Document Number Estimated Expiration
Japan5711867► Subscribe
South Korea20160061310► Subscribe
Australia2014287408► Subscribe
Mexico2016000121► Subscribe
Japan5694944► Subscribe
Australia2009308922► Subscribe
Japan5538461► Subscribe
World Intellectual Property Organization (WIPO)2010051348► Subscribe
Austria516037► Subscribe
Russian Federation2005136438► 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 Certificates for Tradename: IVERMECTIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00045Denmark► SubscribePRODUCT 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
915Luxembourg► SubscribePRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
/2015Austria► SubscribePRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
0150035 00175Estonia► SubscribePRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
00756Netherlands► SubscribePRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
C0069France► SubscribePRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
2015000079Germany► SubscribePRODUCT 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
2015033Lithuania► SubscribePRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Federal Trade Commission
McKinsey
UBS
US Department of Justice
Fish and Richardson
Queensland Health
Merck
Novartis

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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