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EXFORGE HCT Drug Profile
When do Exforge Hct patents expire, and what generic alternatives are available?
Exforge Hct is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has sixty-two patent family members in thirty-two countries.
The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for EXFORGE HCT
| International Patents: | 62 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 14 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXFORGE HCT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXFORGE HCT |
| DailyMed Link: | EXFORGE HCT at DailyMed |
Recent Clinical Trials for EXFORGE HCT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | Phase 4 |
| Hanlim Pharm. Co., Ltd. | Phase 1 |
| Severance Hospital | Phase 1 |
Recent Litigation for EXFORGE HCT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NOVARTIS PHARMACEUTICALS CORPORATION v. LUPIN LTD. | 2012-07-20 |
| Novartis Pharmaceuticals Corporation v. Lupin Ltd. | 2012-05-14 |
| Walgreen CO v. Novartis Pharmaceuticals Corporation |
Pharmacology for EXFORGE HCT
| Drug Class | Dihydropyridine Calcium Channel Blocker Angiotensin 2 Receptor Blocker Thiazide Diuretic |
| Mechanism of Action | Calcium Channel Antagonists Angiotensin 2 Receptor Antagonists |
| Physiological Effect | Increased Diuresis |
Paragraph IV (Patent) Challenges for EXFORGE HCT
| 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 |
US Patents and Regulatory Information for EXFORGE HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| >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 HCT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 022314-003 | Apr 30, 2009 | Start Trial | Start Trial |
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-005 | Apr 30, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXFORGE HCT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1652777 | Start Trial |
| Canada | 2654986 | Start Trial |
| China | 103169711 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1915993 | C300625 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
| 0502314 | SPC/GB11/010 | United Kingdom | Start Trial | PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK |
| 0443983 | C300445 | Netherlands | Start Trial | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
