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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021753

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NDA 021753 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from eight suppliers. There are nine patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DIFFERIN profile page.

The generic ingredient in DIFFERIN is adapalene. There are eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the adapalene profile page.

Summary for NDA: 021753

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

Pharmacology for NDA: 021753

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 021753

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFFERIN
adapalene
GEL;TOPICAL 021753 NDA Galderma Laboratories, L.P. 0299-5918 0299-5918-02 2 g in 1 TUBE (0299-5918-02)
DIFFERIN
adapalene
GEL;TOPICAL 021753 NDA Galderma Laboratories, L.P. 0299-5918 0299-5918-15 1 TUBE in 1 CARTON (0299-5918-15) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%
Approval Date:Jun 19, 2007TE:ABRLD:Yes
Patent:7,737,181Patent Expiration:Aug 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:7,838,558Patent Expiration:Mar 12, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,579,377Patent Expiration:Feb 23, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS

Expired Orange Book Patents for NDA: 021753

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007RE34440► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 20074,717,720► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Fish and Richardson
Cipla
Covington
US Army
Accenture
Medtronic
Teva
Farmers Insurance

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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