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Last Updated: November 5, 2024

SOOLANTRA Drug Patent Profile


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Which patents cover Soolantra, and what generic alternatives are available?

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. Twenty 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
Zydus Worldwide DMCCPhase 3
Catawba Research, LLCPhase 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

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

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

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

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

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

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

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SOOLANTRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SOOLANTRA

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

Country Patent Number Title Estimated Expiration
Lithuania C1620113 ⤷  Sign Up
Japan 2012126738 USE OF IVERMECTIN FOR TREATMENT OF DERMATOLOGICAL DISEASE ⤷  Sign Up
Israel 243314 טיפול בנגעים דלקתיים של רוזצאה על ידי איוורמקטין (Treatment of inflammatory lesions of rosacea with ivermectin) ⤷  Sign Up
Canada 2522579 FORMULATION A USAGE TOPIQUE D'IVERMECTINE POUR LE TRAITEMENTDE CONDITIONS DERMATOLOGIQUES (TOPICAL FORMULATION OF IVERMECTIN FOR THE TREATMENT OF DERMATOLOGICAL CONDITIONS) ⤷  Sign Up
Australia 2014287422 Treatment of papulopustular rosacea with ivermectin ⤷  Sign Up
>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 ⤷  Sign Up 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 PA2015033 Lithuania ⤷  Sign Up PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 C01620113/01 Switzerland ⤷  Sign Up PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
1620113 56/2015 Austria ⤷  Sign Up PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
1620113 122015000079 Germany ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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