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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.

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.

Summary for SOOLANTRA

US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	64
Clinical Trials:	4
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SOOLANTRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOOLANTRA
DailyMed Link:	SOOLANTRA at DailyMed

Pharmacology for SOOLANTRA

Drug Class

Antiparasitic Pediculicide

Medical Subject Heading (MeSH) Categories for SOOLANTRA

Antiparasitic Agents

Insecticides

Synonyms for SOOLANTRA

(1'R,2R,4'S,10'E,14'E,16'E,21'R)-6-(butan-2-yl)-21',24'-dihydroxy-12'-{[(2R,4S,6S)-5-{[(2S,4S,6S)-5-hydroxy-4-methoxy-6-methyloxan-2-yl]oxy}-4-methoxy-6-methyloxan-2-yl]oxy}-5,11',13',22'-tetramethyl-3',7',19'-trioxaspiro[oxa

(2ae,4e,5's,6s,6'r,7s,8e,11r,13r,15s,17ar,20r,20ar,20bs)-6'-[(2s)-Butan-2-Yl]-20,20b-Dihydroxy-5',6,8,19-Tetramethyl-17-Oxo-3',4',5',6,6',10,11,14,15,17,17a,20,20a,20b-Tetradecahydro-2h,7h-Spiro[11,15-Methanofuro[4,3,2-Pq][2,

(2R,5'S,6'R)-dihydroxy-[(2R,4S,5S,6S)-5-[(2S,4S,5S,6S)-5-hydroxy-4-methoxy-6-methyl-tetrahydropyran-2-yl]oxy-4-methoxy-6-methyl-tetrahydropyran-2-yl]oxy-5'-tetramethyl-6'-[(1S)-1-methylpropyl]spiro[[?]-2,2'-tetrahydropyran]on

(Unlabeled)Ivermectin-d2

116522-39-5

123022-60-6

139645-33-3

22,23-Dihydro C-076B1

22,23-Dihydro-5-O-demethylavermectin A1a

22,23-Dihydroavermectin B(1)a

22,23-Dihydroavermectin B1|||Heartgard 30|||Ivomec|||Ivosint|||Mectizan|||Stromectol|||Uvemec|||Vermic|||Zimecterin

22,23-Dihydroavermectin B1a

288I867

5-O-demethyl-22,23-dihydroavermectin A1a

70161-11-4

70288-86-7

71827-03-7

73910-57-3

91Y2202OUW

AB00513813

AB00513813_04

AB00513813-02

AB00513813-03

AB01563172_01

AC1MJ4GR

AC1N7O27

AKOS015969666

AKOS027470116

AS-14167

Avermectin A1a, 22,23-dihydro-5-O-demethyl-

Avermectin A1a, 5-O-demethyl-22,23-dihydro-

avermectin H2B1a

AZSNMRSAGSSBNP-XPNPUAGNSA-N

BDBM50409816

Bio-0055

BPBio1_000322

BRD-A48570745-001-01-1

BRD-K24652731-001-02-7

BRN 4643153

BSPBio_000292

C48H74O14 (B1a form)

CA011349

CAS-71827-03-7

CCG-204778

CCG-213693

CCG-220156

CHEBI:63941

CHEBI:91732

CHEBI:94551

CHEMBL1699565

CHEMBL1876587

CHEMBL263291

D09YHJ

dihydro avermectin Bla

Dihydroavermectin B1a

DSSTox_CID_3181

DSSTox_GSID_23181

DSSTox_RID_76909

DTXSID8023181

EINECS 276-046-2

EU-0100693

FT-0082656

GTPL2373

H2B1a

Heartgard 30

HMS1568O14

HMS2089M09

HMS2091E11

HMS2095O14

HMS2233J07

HMS3262K07

I 8898

I1850

IVERMECTIN

Ivermectin (MK-0933)

Ivermectin B1a

Ivermectin-d2

Ivermectin, Antibiotic for Culture Media Use Only

Ivermectin, European Pharmacopoeia (EP) Reference Standard

Ivermectin, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Ivermectin, United States Pharmacopeia (USP) Reference Standard

IvermectinB1a

Ivexterm (TN)

IVM

Ivosint

J10179

Lopac0_000693

LP00693

Mectizan (TN)

MK-933

MLS001333247

MLS001333248

MLS002153248

MolPort-006-394-715

MolPort-020-015-936

MolPort-044-878-307

NCGC00094047-01

NCGC00094047-02

NCGC00163233-01

NCGC00186639-01

NCGC00261378-01

NSC-755843

NSC755843

Pharmakon1600-01300027

Prestwick_516

Prestwick2_000156

Prestwick3_000156

Q-201262

RL04692

s1351

SCHEMBL13259385

SCHEMBL17212450

SCHEMBL312795

Sklice

SMR000857211

SR-01000075941

SR-01000075941-1

Stromectol (TN)

Tox21_112034

Tox21_500693

UNII-8883YP2R6D component AZSNMRSAGSSBNP-XPNPUAGNSA-N

UNII-91Y2202OUW

VA11120

ZINC238808778

ZINC252286706

ZINC253630390

ZINC301054281

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

Paragraph IV (Patent) Challenges for SOOLANTRA

Drugname	Dosage	Strength	RLD	Date
	Cream	1%

International Patents for SOOLANTRA

Country	Document Number	Estimated Expiration
Brazil	PI0410503
Canada	2916668
Mexico	2016000121
New Zealand	716034
World Intellectual Property Organization (WIPO)	2015006319

Supplementary Protection Certificates for SOOLANTRA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2015	Austria		PRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
15/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
00756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
0756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; FIRST REGISTRATION NO/DATE: MA117/01101 20150402; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504