EXFORGE HCT Drug Patent 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.
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.
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Summary for EXFORGE HCT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 15 |
| 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 |
|---|---|
| International Bio service | Phase 1 |
| Novartis Pharmaceuticals | Phase 4 |
| Hanlim Pharm. 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 |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-003 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-005 | Apr 30, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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
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
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA, E HIDROCLOROTIAZIDA, Y METODO PARA ELABORARLAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07265138
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0713785
Patent: formas de dosagem sólidas de valsartana, amlodipina e hidroclorotiazida e métodos de fabricação das mesmas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 54986
Patent: FORMES GALENIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR METHODE DE FABRICATION (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07001870
Patent: COMPOSICION FARMACEUTICA DE DOSIFICACION SOLIDA QUE COMPRENDE VALSARTAN, AMLODIPINA, HIDROCLOROTIAZIDA Y ADITIVOS FARMACEUTICAMENTE ACEPTABLES; PROCEDIMIENTO DE PREPARACION; Y USO PARA EL TRATAMIENTO DE HIPERTENSION, INSUFICIENCIA CARDIACA, INFARTO D
Estimated Expiration: ⤷ Sign Up
China
Patent: 1478956
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Sign Up
Patent: 3169711
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making same
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 088987
Patent: FORMAS DE DOSIFICACIÓN SÓLIDAS DE VALSARTAN, AMLODIPINA, E HIDROCLOROTIAZIDA, Y MÉTODO PARA ELABORARLAS
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 37893
Patent: FORMES GALÉNIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR MÉTHODE DE FABRICATION (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 33818
Patent: SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09542709
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 08016532
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA, E HIDROCLOROTIAZIDA, Y METODO PARA ELABORARLAS. (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 529
Patent: FORMES GALENIQUES SOLIDES DU VALSARTAN, DE L'AMLODIPINE ET DE L'HYDROCHLOROTHIAZIDE ET LEUR METHODE DE FABRICATION
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3295
Patent: Bilayer tablets containing a combination of valsartan, amlodipine and a diuretic and method of making the same
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 090314
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 080991
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA E HIDROCLOROTIAZIDA Y METODO PARA ELABORARLAS
Estimated Expiration: ⤷ Sign Up
Patent: 120542
Patent: FORMAS DE DOSIFICACION SOLIDAS DE VALSARTAN, AMLODIPINA E HIDROCLOROTIAZIDA Y METODO PARA ELABORARLAS
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 49786
Patent: ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD FOR MAKING THEM)
Estimated Expiration: ⤷ Sign Up
Patent: 09102273
Patent: ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0810053
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090021191
Patent: SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0808379
Patent: Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 08538
Patent: SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Hong Kong | 1074773 | COMBINATION COMPRISING VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE | ⤷ Sign Up |
| Mexico | PA04011385 | COMBINACION DE COMPUESTOS ORGANICOS. (COMBINATION OF ORGANIC COMPOUNDS.) | ⤷ Sign Up |
| Taiwan | I358291 | ⤷ Sign Up | |
| Ecuador | SP045429 | COMBINACION DE COMPUESTOS ORGANICOS | ⤷ Sign Up |
| Hong Kong | 1133818 | SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF MAKING THE SAME | ⤷ Sign Up |
| South Korea | 101208430 | ⤷ Sign Up | |
| Cyprus | 2553 | Solid oral dosage forms of valsartan | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE HCT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0443983 | 2007C/043 | Belgium | ⤷ Sign Up | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
| 0502314 | SPC/GB11/010 | United Kingdom | ⤷ Sign Up | 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 |
| 0678503 | C300499 | Netherlands | ⤷ Sign Up | 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 | C980036 | Netherlands | ⤷ Sign Up | 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 |
| 1507558 | 12C0033 | France | ⤷ Sign Up | PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705 |
| 0443983 | 97C0039 | Belgium | ⤷ Sign Up | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 |
| 0443983 | 98C004 | Belgium | ⤷ Sign Up | PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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