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Serving 500+ biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Harvard Business School
Chubb
Baxter
Dow
Chinese Patent Office
Accenture
Cipla
Express Scripts

Generated: June 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206255

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NDA 206255 describes SOOLANTRA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SOOLANTRA profile page.

The generic ingredient in SOOLANTRA is ivermectin. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

Summary for NDA: 206255

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antiparasitics
Formulation / Manufacturing:see details

Pharmacology for NDA: 206255

Suppliers and Packaging for NDA: 206255

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOOLANTRA
ivermectin
 CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823 0299-3823-30 1 TUBE in 1 CARTON (0299-3823-30) > 30 g in 1 TUBE
SOOLANTRA
ivermectin
 CREAM;TOPICAL 206255 NDA Galderma Laboratories, L.P. 0299-3823 0299-3823-45 1 TUBE in 1 CARTON (0299-3823-45) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:5,952,372Patent Expiration:Sep 18, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
Patent:6,133,310Patent Expiration:Apr 26, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Mallinckrodt
Johnson and Johnson
Colorcon
Teva
Chinese Patent Office
Boehringer Ingelheim
Dow
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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