DrugPatentWatch Database Preview
EXFORGE Drug Profile
» See Plans and Pricing
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 two 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. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
US ANDA Litigation and Generic Entry Outlook for Exforge
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
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Bulk Api Vendors: | 128 |
Clinical Trials: | 14 |
Patent Applications: | 2,488 |
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 |



Recent Clinical Trials for EXFORGE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Novartis Pharmaceuticals | Phase 4 |
Hanlim Pharm. Co., Ltd. | Phase 1 |
Severance Hospital | Phase 1 |
Paragraph IV (Patent) Challenges for EXFORGE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-11-26 |
EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-11-09 |
EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-10-22 |
EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-10-01 |
US Patents and Regulatory Information for EXFORGE
Expired US Patents for EXFORGE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | Start Trial | Start Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | Start Trial | Start Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | Start Trial | Start Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | Start Trial | Start Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | Start Trial | Start Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXFORGE
Country | Patent Number | Estimated Expiration |
---|---|---|
South Korea | 101208430 | Start Trial |
Finland | 980787 | Start Trial |
Portugal | 914119 | Start Trial |
Germany | 69739642 | Start Trial |
United Kingdom | 9613470 | Start Trial |
Japan | 2014012747 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0503785 | C300375 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN OLMESARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN AMLODIPINEBESILAAT; REGISTRATION NO/DATE: RVG100984, RVG100986-87, RVG100989-91, RVG100993-95 20080819 |
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 |
1003503 | 05C0048 | France | Start Trial | PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707 |
0443983 | C980036 | Netherlands | Start Trial | PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925 |
0443983 | 91347 | Luxembourg | Start Trial | 91347, EXPIRES: 20160212 |
0503785 | C300486 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |