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Details for New Drug Application (NDA): 022314
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NDA 022314 describes EXFORGE HCT, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the EXFORGE HCT profile page.
The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for 022314
| Tradename: | EXFORGE HCT |
| Applicant: | Novartis |
| Ingredient: | amlodipine besylate; hydrochlorothiazide; valsartan |
| Patents: | 2 |
Pharmacology for NDA: 022314
| Mechanism of Action | Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 022314
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314 | NDA | Novartis Pharmaceuticals Corporation | 0078-0559 | 0078-0559-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0559-15) |
| EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314 | NDA | Novartis Pharmaceuticals Corporation | 0078-0560 | 0078-0560-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0560-15) |
Paragraph IV (Patent) Challenges for 022314
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXFORGE HCT | TABLET;ORAL | amlodipine besylate; hydrochlorothiazide; valsartan | 022314 | 2009-10-22 |
| EXFORGE HCT | TABLET;ORAL | amlodipine besylate; hydrochlorothiazide; valsartan | 022314 | 2009-09-14 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;12.5MG;160MG | ||||
| Approval Date: | Apr 30, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 16, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Nov 16, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE;25MG;160MG | ||||
| Approval Date: | Apr 30, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 16, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022314
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-005 | Apr 30, 2009 | Start Trial | Start Trial |
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | Start Trial | Start Trial |
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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