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The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Paragraph IV (Patent) Challenges for EXFORGE
|➤ Subscribe||Tablets||5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 m||➤ Subscribe||9/14/2009|
|➤ Subscribe||Tablets||10 mg/12.5 mg/160 mg||➤ Subscribe||10/22/2009|
|➤ Subscribe||Tablets||5 mg/320 mg||➤ Subscribe||11/26/2007|
|➤ Subscribe||Tablets||10 mg/320 mg||➤ Subscribe||11/9/2007|
|➤ Subscribe||Tablets||5 mg/160 mg||➤ Subscribe||10/22/2007|
|➤ Subscribe||Tablets||10 mg/160 mg||➤ Subscribe||10/1/2007|
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.