SOOLANTRA Drug Patent Profile

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 24^th, 2014.

Summary for SOOLANTRA

International Patents:	76
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (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
Catawba Research, LLC	Phase 3
Zydus Worldwide DMCC	Phase 3

See all SOOLANTRA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SOOLANTRA

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

P02CF	Avermectines
P02C	ANTINEMATODAL AGENTS
P02	ANTHELMINTICS
P	Antiparasitic products, insecticides and repellents

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

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

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

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

Country	Patent Number	Title	Estimated Expiration
Spain	2371945
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)
Israel	243315	טיפול של פאפולוסטר רוסאסיה דרך איברמקטין (Treatment of papulopustular rosacea with ivermectin)
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)
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)
South Africa	201600358	TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA WITH IVERMECTIN
World Intellectual Property Organization (WIPO)	2015006305

Supplementary Protection Certificates for SOOLANTRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	PA2015033	Lithuania		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		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		PRODUCT NAME: IVERMECTINE; NAT. REGISTRATION NO/DATE: NL 44511 20150721; FIRST REGISTRATION: MT - MA 117/01101 20150402
1620113	CR 2015 00045	Denmark		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		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		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