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Last Updated: October 26, 2021

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Details for New Drug Application (NDA): 202331

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NDA 202331 describes EDARBYCLOR, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the EDARBYCLOR profile page.

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
Summary for 202331
Applicant:Arbor Pharms Llc
Ingredient:azilsartan kamedoxomil; chlorthalidone
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 202331
Generic Entry Date for 202331*:
Constraining patent/regulatory exclusivity:

*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.

Pharmacology for NDA: 202331
Suppliers and Packaging for NDA: 202331
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331 NDA Arbor Pharmaceuticals 60631-412 60631-412-30 30 TABLET in 1 BOTTLE (60631-412-30)
EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331 NDA Arbor Pharmaceuticals 60631-425 60631-425-30 30 TABLET in 1 BOTTLE (60631-425-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG MEDOXOMIL;12.5MG
Approval Date:Dec 20, 2011TE:RLD:Yes
Patent:⤷  Free Forever TrialPatent Expiration:May 22, 2025Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Jan 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Free Forever TrialPatent Expiration:Mar 26, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202331

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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.