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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Accenture
McKesson
Boehringer Ingelheim
McKinsey
Cipla
Covington
Healthtrust
Dow
QuintilesIMS

Generated: January 18, 2018

DrugPatentWatch Database Preview

IVERMECTIN - Generic Drug Details

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What are the generic 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 fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ivermectin has eighty-three 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
Pharmacology for IVERMECTIN
Medical Subject Heading (MeSH) Categories for IVERMECTIN

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 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742-001 Nov 22, 1996 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Merck Sharp Dohme STROMECTOL ivermectin TABLET;ORAL 050742-002 Oct 8, 1998 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Arbor Pharms Llc SKLICE ivermectin LOTION;TOPICAL 202736-001 Feb 7, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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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
9,782,425 Treatment of papulopustular rosacea with ivermectin ➤ Subscribe
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
Patent No. Title Estimated Patent Expiration

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International Patents for IVERMECTIN

Supplementary Protection Certificates for IVERMECTIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015033 Lithuania ➤ Subscribe PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
2015000079 Germany ➤ Subscribe 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
00756 Netherlands ➤ Subscribe PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
0150035 00175 Estonia ➤ Subscribe PRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
0756 Netherlands ➤ Subscribe PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504
C0069 France ➤ Subscribe PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
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
/2015 Austria ➤ Subscribe PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
915 Luxembourg ➤ Subscribe PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
15/046 Ireland ➤ Subscribe PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
Daiichi Sankyo
Teva
AstraZeneca
Medtronic
Baxter
Dow
Julphar

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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