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Last Updated: May 27, 2022

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-six patent family members in twenty-eight countries.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Fourteen 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

See drug prices for SOOLANTRA

Drug Sales Revenue Trends for SOOLANTRA

See drug sales revenues for SOOLANTRA

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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of inflammatory lesions of rosacea with ivermectin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.

Treatment of papulopustular rosacea with ivermectin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 See Plans and Pricing See Plans and Pricing
>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
Spain 2371945 See Plans and Pricing
Japan 2021059590 イベルメクチンを用いた、酒さの炎症性病変の治療 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN) See Plans and Pricing
Israel 243315 טיפול של פאפולוסטר רוסאסיה דרך איברמקטין (Treatment of papulopustular rosacea with ivermectin) See Plans and Pricing
Japan 2017197562 イベルメクチンを用いた、酒さの炎症性病変の治療 (TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN) See Plans and Pricing
Hong Kong 1223841 使用伊維菌素治療丘疹膿皰性紅斑痤瘡 (TREATMENT OF PAPULOPUSTULAR ROSACEA WITH IVERMECTIN) See Plans and Pricing
South Africa 201600358 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN See Plans and Pricing
World Intellectual Property Organization (WIPO) 2015006305 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SOOLANTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 PA2015033 Lithuania See Plans and Pricing PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 300756 Netherlands See Plans and Pricing PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402
1620113 15C0069 France See Plans and Pricing PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113 CR 2015 00045 Denmark See Plans and Pricing PRODUCT NAME: LVERMECTIN (22,23-DIHYDROAVERMECTIN B1 A + 22,23-DIHYDROAVERMECTIN B1 B); NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113 CA 2015 00045 Denmark See Plans and Pricing 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,C1620113 Lithuania See Plans and Pricing PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 C01620113/01 Switzerland See Plans and Pricing PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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