Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021234

See Plans and Pricing

« Back to Dashboard

NDA 021234 describes FLECTOR, which is a drug marketed by Inst Biochem and is included in one NDA. It is available from eight suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FLECTOR profile page.

The generic ingredient in FLECTOR is diclofenac epolamine. There are forty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the diclofenac epolamine profile page.
Summary for 021234
Applicant:Inst Biochem
Ingredient:diclofenac epolamine
Formulation / Manufacturing:see details
Pharmacology for NDA: 021234
Suppliers and Packaging for NDA: 021234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLECTOR diclofenac epolamine PATCH;TOPICAL 021234 NDA AUTHORIZED GENERIC Teva Pharmaceuticals USA Inc. 0093-3225 0093-3225-55 6 POUCH in 1 CARTON (0093-3225-55) > 5 PATCH in 1 POUCH (0093-3225-50)
FLECTOR diclofenac epolamine PATCH;TOPICAL 021234 NDA Quality Care Products, LLC 35356-077 35356-077-30 6 POUCH in 1 CARTON (35356-077-30) > 5 PATCH in 1 POUCH
Paragraph IV (Patent) Challenges for 021234
Tradename Dosage Ingredient NDA Submissiondate
FLECTOR PATCH;TOPICAL diclofenac epolamine 021234 2015-06-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength1.3%
Approval Date:Jan 31, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 13, 2019Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim

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.