EXFORGE Drug Patent Profile
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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 four Paragraph IV challenges.
The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
DrugPatentWatch® Generic Entry Outlook for Exforge
There are four Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for EXFORGE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 14 |
Patent Applications: | 3,144 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EXFORGE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXFORGE |
What excipients (inactive ingredients) are in EXFORGE? | EXFORGE excipients list |
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 |
Dong-A Pharmaceutical Co., Ltd. | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for EXFORGE
Paragraph IV (Patent) Challenges for EXFORGE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXFORGE | Tablets | amlodipine besylate; valsartan | 5 mg/320 mg | 021990 | 1 | 2007-11-26 |
EXFORGE | Tablets | amlodipine besylate; valsartan | 10 mg/320 mg | 021990 | 1 | 2007-11-09 |
EXFORGE | Tablets | amlodipine besylate; valsartan | 5 mg/160 mg | 021990 | 1 | 2007-10-22 |
EXFORGE | Tablets | amlodipine besylate; valsartan | 10 mg/160 mg | 021990 | 1 | 2007-10-01 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-005 | Apr 30, 2009 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 | 021990-003 | Jun 20, 2007 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | See Plans and Pricing | See Plans and Pricing |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXFORGE
See the table below for patents covering EXFORGE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 371449 | See Plans and Pricing | |
European Patent Office | 1767206 | Formes orales solides comprenant du valsartan et de l'hydrochlorothiazide (Solid oral dosage forms comprising valsartan and hydrochlorothiazide) | See Plans and Pricing |
Japan | 2000506540 | See Plans and Pricing | |
South Korea | 101208430 | See Plans and Pricing | |
Hong Kong | 1019858 | See Plans and Pricing | |
Mexico | 24598 | PROCEDIMIENTO PARA PREPARAR UN COMPUESTO DE ACILO, PRODUCTO OBTENIDO Y PREPARACION FARMACEUTICA QUE LO INCLUYE. | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | C00443983/03 | Switzerland | See Plans and Pricing | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
0443983 | C980036 | Netherlands | See Plans and Pricing | 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 |
1915993 | 92315 | Luxembourg | See Plans and Pricing | PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE |
0443983 | SPC/GB97/009 | United Kingdom | See Plans and Pricing | PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016 |
0443983 | 97C0039 | Belgium | See Plans and Pricing | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 |
1507558 | 2012/018 | Ireland | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |