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Last Updated: September 27, 2023

SOOLANTRA Drug Patent 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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-seven patent family members in twenty-eight countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Soolantra

A generic version of SOOLANTRA was approved as ivermectin by EDENBRIDGE PHARMS on October 24th, 2014.

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Drug patent expirations by year for SOOLANTRA
Drug Prices for SOOLANTRA

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Drug Sales Revenue Trends for SOOLANTRA

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Recent Clinical Trials for SOOLANTRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2
Catawba Research, LLCPhase 3
Zydus Worldwide DMCCPhase 3

See all SOOLANTRA clinical trials

Pharmacology for SOOLANTRA
Paragraph IV (Patent) Challenges for SOOLANTRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SOOLANTRA Cream ivermectin 1% 206255 1 2016-12-30

US Patents and Regulatory Information for SOOLANTRA

SOOLANTRA is protected by twelve US patents.

Patents protecting SOOLANTRA

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of inflammatory lesions of rosacea with ivermectin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

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;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SOOLANTRA

See the table below for patents covering SOOLANTRA around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1111797 ⤷  Try a Trial
Mexico PA05011208 USO DE IVERMECTINA PARA EL TRATAMIENTO DE DESORDENES DERMATOLOGICOS. (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS.) ⤷  Try a Trial
Israel 243314 טיפול בנגעים דלקתיים של רוזצאה על ידי איוורמקטין (Treatment of inflammatory lesions of rosacea with ivermectin) ⤷  Try a Trial
Japan 2006524212 ⤷  Try a Trial
South Korea 101187231 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SOOLANTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 CA 2015 00045 Denmark ⤷  Try a Trial 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
1620113 C 2015 036 Romania ⤷  Try a Trial PRODUCT NAME: IVERMECTINA; NATIONAL AUTHORISATION NUMBER: RO7674/2015/01, RO7674/2015/02, RO7674/2015/03, RO7674/2015/04, RO7674/2015/05; DATE OF NATIONAL AUTHORISATION: 20150526; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MALTA MA117/01101; DATE OF FIRST AUTHORISATION IN EEA: 20150402
1620113 56/2015 Austria ⤷  Try a Trial PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
1620113 C01620113/01 Switzerland ⤷  Try a Trial PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
1620113 C300756 Netherlands ⤷  Try a Trial PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Medtronic
Moodys
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Johnson and Johnson

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