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Serving leading biopharmaceutical companies globally:

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Generated: December 17, 2017

DrugPatentWatch Database Preview

SOOLANTRA Drug Profile

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When do Soolantra patents expire, and when can generic versions of Soolantra launch?

Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in twenty-six countries and ten supplementary protection certificates in nine countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ivermectin profile page.
Drug patent expirations by year for SOOLANTRA

Pharmacology for SOOLANTRA

Medical Subject Heading (MeSH) Categories for SOOLANTRA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for SOOLANTRA

Drugname Dosage Strength RLD Submissiondate
ivermectinCream1%Soolantra12/30/2016

Non-Orange Book Patents for Tradename: SOOLANTRA

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 Tradename: SOOLANTRA

Country Document Number Estimated Expiration
Slovenia1620113► Subscribe
China105828825► Subscribe
Russian Federation2005136438► Subscribe
Japan2016526572► Subscribe
Japan2006524212► Subscribe
Singapore11201510420U► Subscribe
Japan2016523968► Subscribe
South Africa200507346► Subscribe
South Korea101291824► Subscribe
China105792829► 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: SOOLANTRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0069France► SubscribePRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
915Luxembourg► SubscribePRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 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
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
15/046Ireland► SubscribePRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
00756Netherlands► SubscribePRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: 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
0150035 00175Estonia► SubscribePRODUCT NAME: IVERMEKTIIN;REG NO/DATE: EE 872915 08.06.2015
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Serving leading biopharmaceutical companies globally:

Deloitte
Cipla
QuintilesIMS
Novartis
Accenture
Mallinckrodt
Julphar
Cerilliant
AstraZeneca
Queensland Health

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