EXFORGE HCT Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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-one 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. 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 Hct
There are two 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 HCT
International Patents: | 61 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product 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 |
Dong-A Pharmaceutical Co., Ltd. | Phase 1 |
Pharmacology for EXFORGE HCT
Drug Class | Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic |
Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for EXFORGE HCT
Paragraph IV (Patent) Challenges for EXFORGE HCT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXFORGE HCT | Tablets | amlodipine besylate; hydrochlorothiazide; valsartan | 10 mg/12.5 mg/ 160 mg | 022314 | 1 | 2009-10-22 |
EXFORGE HCT | Tablets | amlodipine besylate; hydrochlorothiazide; valsartan | 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 mg | 022314 | 1 | 2009-09-14 |
US Patents and Regulatory Information for EXFORGE HCT
EXFORGE HCT is protected by one US patents.
Patents protecting EXFORGE HCT
Pharmaceutical composition containing anti-hypertensive agents
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | 022314-005 | Apr 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXFORGE HCT
When does loss-of-exclusivity occur for EXFORGE HCT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1627
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07265138
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0713785
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 54986
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07001870
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1478956
Estimated Expiration: ⤷ Try a Trial
Patent: 3169711
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 088987
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 37893
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 33818
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09542709
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 08016532
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 529
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3295
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 090314
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 080991
Estimated Expiration: ⤷ Try a Trial
Patent: 120542
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 49786
Estimated Expiration: ⤷ Try a Trial
Patent: 09102273
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0810053
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 090021191
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 0808379
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 08538
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering EXFORGE HCT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20090099020 | ⤷ Try a Trial | |
Ecuador | SP045429 | COMBINACION DE COMPUESTOS ORGANICOS | ⤷ Try a Trial |
Spain | 2084801 | ⤷ Try a Trial | |
Germany | 122010000024 | ⤷ Try a Trial | |
China | 101478956 | Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same | ⤷ Try a Trial |
Spain | 2231873 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE HCT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0502314 | SPC/GB11/010 | United Kingdom | ⤷ Try a 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 | C00443983/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
0443983 | C300445 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016 |
1507558 | 2012/018 | Ireland | ⤷ Try a 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 |
1507558 | C300528 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705 |
0443983 | 91347 | Luxembourg | ⤷ Try a Trial | 91347, EXPIRES: 20160212 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |