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Last Updated: June 17, 2024

Details for New Drug Application (NDA): 021902


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NDA 021902 describes VEREGEN, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the VEREGEN profile page.

The generic ingredient in VEREGEN is sinecatechins. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sinecatechins profile page.
Summary for 021902
Tradename:VEREGEN
Applicant:Ani Pharms
Ingredient:sinecatechins
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021902
Generic Entry Date for 021902*:
Constraining patent/regulatory exclusivity:
Dosage:
OINTMENT;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 021902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VEREGEN sinecatechins OINTMENT;TOPICAL 021902 NDA PharmaDerm a division of Fougera Pharmaceuticals Inc. 10337-450 10337-450-08 1 TUBE in 1 CARTON (10337-450-08) / 2 g in 1 TUBE
VEREGEN sinecatechins OINTMENT;TOPICAL 021902 NDA ANI Pharmaceuticals, Inc. 62559-385 62559-385-26 6 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength15%
Approval Date:Oct 31, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Oct 2, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF GENITAL WARTS
Patent:⤷  Sign UpPatent Expiration:Jul 12, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF GENITAL WARTS

Expired US Patents for NDA 021902

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 ⤷  Sign Up ⤷  Sign Up
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 ⤷  Sign Up ⤷  Sign Up
Ani Pharms VEREGEN sinecatechins OINTMENT;TOPICAL 021902-001 Oct 31, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.