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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 eleven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Eight 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 October 24^th, 2014.

Summary for SOOLANTRA

International Patents:	75
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	64
Clinical Trials:	6
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SOOLANTRA
Drug Sales Revenues:	Drug sales revenues for SOOLANTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOOLANTRA
What excipients (inactive ingredients) are in SOOLANTRA?	SOOLANTRA excipients list
DailyMed Link:	SOOLANTRA at DailyMed

See drug prices for SOOLANTRA

See drug sales revenues for SOOLANTRA

Recent Clinical Trials for SOOLANTRA

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

Sponsor	Phase
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2
Zydus Worldwide DMCC	Phase 3
Catawba Research, LLC	Phase 3

See all SOOLANTRA clinical trials

Pharmacology for SOOLANTRA

Drug Class

Antiparasitic Pediculicide

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			Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes			Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes			Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes

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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014

International Patents for SOOLANTRA

Country	Patent Number	Estimated Expiration
Israel	243315
China	105828825
South Korea	101863085
Austria	516037

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	C 2015 036	Romania		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	2015/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113	PA2015033,C1620113	Lithuania		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		PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016