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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Healthtrust
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QuintilesIMS
Cantor Fitzgerald
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Dow

Generated: December 12, 2017

DrugPatentWatch Database Preview

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 two suppliers. There are four patents protecting this drug. Additional details are available on the EDARBYCLOR profile page.

The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.

Summary for 202331

Tradename:1
Applicant:1
Ingredient:1
Patents:4
Formulation / Manufacturing:see details

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 60631-412-07 5 BLISTER PACK in 1 TRAY (60631-412-07) > 7 TABLET in 1 BLISTER PACK
EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331 NDA Arbor Pharmaceuticals 60631-412 60631-412-30 30 TABLET in 1 BOTTLE (60631-412-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG MEDOXOMIL;12.5MG
Approval Date:Dec 20, 2011TE:RLD:Yes
Patent:► SubscribePatent Expiration:May 22, 2025Product Flag?Substance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Jan 7, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION
Patent:► SubscribePatent Expiration:Mar 26, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202331

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-001Dec 20, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-002Dec 20, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-002Dec 20, 2011► Subscribe► Subscribe
Arbor Pharms LlcEDARBYCLORazilsartan kamedoxomil; chlorthalidoneTABLET;ORAL202331-001Dec 20, 2011► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fuji
Farmers Insurance
Express Scripts
US Army
Deloitte
Federal Trade Commission
Fish and Richardson
Queensland Health
Teva
Argus Health

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