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EXFORGE HCT Drug Profile
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Which patents cover Exforge Hct, 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. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
US ANDA Litigation and Generic Entry Outlook for Exforge Hct
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for EXFORGE HCT
International Patents: | 62 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
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 |
What excipients (inactive ingredients) are in EXFORGE HCT? | EXFORGE HCT excipients list |
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 |
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
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 | 022314-005 | 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 |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | 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 |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | 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 |
---|---|---|
Israel | 195797 | Start Trial |
European Patent Office | 1774967 | Start Trial |
South Korea | 100618038 | Start Trial |
Russian Federation | 2203054 | Start Trial |
Norway | 20045429 | Start Trial |
New Zealand | 333385 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | C970001 | Netherlands | Start Trial | PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513 |
0678503 | C300499 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114 |
0443983 | 23/1997 | Austria | Start Trial | PRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513 |
0443983 | C00443983/02 | Switzerland | Start Trial | PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006 |
1507558 | 2012/018 | Ireland | Start Trial | PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705 |
0502314 | C300478 | Netherlands | Start Trial | PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |