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Last Updated: October 15, 2019

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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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-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. Six suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

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

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SponsorPhase
Catawba Research, LLCPhase 3
Zydus Worldwide DMCCPhase 3
University of California, San DiegoPhase 1/Phase 2

See all SOOLANTRA clinical trials

Recent Litigation for SOOLANTRA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc.2017-12-11
Galderma Laboratories LP v. Perrigo UK Finco Limited Partnership2017-07-13
Galderma Laboratories LP v. Actavis Laboratories UT Inc2017-04-21

See all SOOLANTRA litigation

Pharmacology for SOOLANTRA

US Patents and Regulatory Information for SOOLANTRA

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 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes   See Pricing   See Pricing   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes   See Pricing   See Pricing   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes   See Pricing   See Pricing   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes   See Pricing   See Pricing Y   See 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 Pricing   See Pricing
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SOOLANTRA
Drugname Dosage Strength RLD Date
➤ Subscribe Cream 1% ➤ Subscribe   See Pricing

Supplementary Protection Certificates for SOOLANTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 PA2015033 Lithuania   See 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 Pricing PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504
1620113 C 2015 036 Romania   See Pricing 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 122015000079 Germany   See Pricing 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
1620113 2015/046 Ireland   See Pricing PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113 PA2015033,C1620113 Lithuania   See 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 15C0069 France   See Pricing PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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