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Ivermectin - Generic Drug Details

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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. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-four patent family members in twenty-six countries.

There are five drug master file entries for ivermectin. Six 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 / Packaging: see list6
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ivermectin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYes8,415,311► subscribeY ► subscribe
Merck Sharp Dohme
STROMECTOL
ivermectin
TABLET;ORAL050742-002Oct 8, 1998RXYes► subscribe► subscribe
Arbor Pharms Llc
SKLICE
ivermectin
LOTION;TOPICAL202736-001Feb 7, 2012RXYes6,103,248► 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
Japan5538461► subscribe
Japan2006524212► subscribe
South Korea101187231► 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
2015033Lithuania► subscribePRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
/2015Austria► subscribePRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
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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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