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Serving leading biopharmaceutical companies globally:

Argus Health
AstraZeneca
Johnson and Johnson
Novartis
Boehringer Ingelheim
Fuji
McKesson
Cerilliant
Colorcon
Daiichi Sankyo

Generated: November 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 eighty-one patent family members in twenty-eight countries and ten supplementary protection certificates in nine countries.

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

Pharmacology for ivermectin

Medical Subject Heading (MeSH) Categories for ivermectin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► 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
Merck Sharp Dohme
STROMECTOL
ivermectin
TABLET;ORAL050742-002Oct 8, 1998ABRXYesYes► 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
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
Edenbridge Pharms
IVERMECTIN
ivermectin
TABLET;ORAL204154-001Oct 24, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Arbor Pharms Llc
SKLICE
ivermectin
LOTION;TOPICAL202736-001Feb 7, 2012RXYesYes► Subscribe► SubscribeY ► 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
Mexico2016000122► Subscribe
New Zealand716033► Subscribe
Chile2016000008► Subscribe
Taiwan201114450► Subscribe
Cyprus1111797► Subscribe
HungaryS1500048► Subscribe
China102231948► Subscribe
Australia2009308922► Subscribe
Portugal1620113► Subscribe
Poland378932► 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
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
0756Netherlands► SubscribePRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504
/2015Austria► SubscribePRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
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
15/046Ireland► SubscribePRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 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
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
0150035 00175Estonia► SubscribePRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
915Luxembourg► SubscribePRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Chinese Patent Office
Express Scripts
Medtronic
Julphar
Cipla
Johnson and Johnson
US Army
Covington

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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