Details for New Drug Application (NDA): 202331
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NDA 202331 describes EDARBYCLOR, which is a drug marketed by Azurity and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the azilsartan kamedoxomil; chlorthalidone profile page.
The generic ingredient in EDARBYCLOR is azilsartan kamedoxomil; chlorthalidone. There are six 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: | EDARBYCLOR |
| Applicant: | Azurity |
| Ingredient: | azilsartan kamedoxomil; chlorthalidone |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202331
*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
| Mechanism of Action | Angiotensin 2 Type 1 Receptor Antagonists |
| Physiological Effect | Decreased Blood Pressure Increased Diuresis |
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 | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 60631-412 | 60631-412-30 | 30 TABLET in 1 BOTTLE (60631-412-30) |
| EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 60631-425 | 60631-425-30 | 30 TABLET in 1 BOTTLE (60631-425-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG MEDOXOMIL;12.5MG | ||||
| Approval Date: | Dec 20, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 22, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 7, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERTENSION | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 26, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 202331
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-001 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| Azurity | EDARBYCLOR | azilsartan kamedoxomil; chlorthalidone | TABLET;ORAL | 202331-002 | Dec 20, 2011 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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