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Last Updated: January 24, 2020

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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-nine 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.

US ANDA Litigation and Generic Entry Outlook for Soolantra

A generic version of SOOLANTRA was approved as ivermectin by EDENBRIDGE PHARMS on January 24th, 2020.

  Start Trial

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
Catawba Research, LLCPhase 3
Zydus Worldwide DMCCPhase 3
GaldermaPhase 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
Paragraph IV (Patent) Challenges for SOOLANTRA
Tradename Dosage Ingredient NDA Submissiondate
SOOLANTRA CREAM;TOPICAL ivermectin 206255 2016-12-30

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

Supplementary Protection Certificates for SOOLANTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 PA2015033,C1620113 Lithuania   Start Trial PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 PA2015033 Lithuania   Start Trial PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113 2015/046 Ireland   Start Trial PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113 C01620113/01 Switzerland   Start Trial PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
1620113 CA 2015 00045 Denmark   Start 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 56/2015 Austria   Start Trial PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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Johnson and Johnson
Express Scripts
Harvard Business School

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