DrugPatentWatch Database Preview
EXFORGE Drug Profile
Which patents cover Exforge, and what generic alternatives are available?
Exforge is a drug marketed by Novartis and is included in two NDAs. There are three patents protecting this drug and six Paragraph IV challenges.
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.
Summary for EXFORGE
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 13 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXFORGE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXFORGE |
| DailyMed Link: | EXFORGE at DailyMed |
Pharmacology for EXFORGE
| Ingredient-type | Dihydropyridines |
| Drug Class | Dihydropyridine Calcium Channel Blocker Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists |
US Patents and Regulatory Information for EXFORGE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for EXFORGE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ➤ Sign Up | ➤ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ➤ Sign Up | ➤ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ➤ Sign Up | ➤ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ➤ Sign Up | ➤ Sign Up |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for EXFORGE
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg/12.5 mg/160 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ 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 | ➤ Sign Up |
| ➤ Subscribe | Tablets | 5 mg/320 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 10 mg/320 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 5 mg/160 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 10 mg/160 mg | ➤ Subscribe | ➤ Sign Up |
