exforge hct Drug Patent Profile
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When do Exforge Hct patents expire, 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.
Summary for exforge hct
| US Patents: | 0 |
| 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 |
| Severance Hospital | 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
| 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 | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-001 | Apr 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Australia
Patent: 07265138
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0713785
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 54986
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07001870
Estimated Expiration: ⤷ Sign Up
China
Patent: 1478956
Estimated Expiration: ⤷ Sign Up
Patent: 3169711
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 088987
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 37893
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 33818
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09542709
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 08016532
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 529
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3295
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 090314
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 080991
Estimated Expiration: ⤷ Sign Up
Patent: 120542
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 49786
Estimated Expiration: ⤷ Sign Up
Patent: 09102273
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0810053
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090021191
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0808379
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 08538
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 |
|---|---|---|---|
| Mexico | PA04011385 | COMBINACION DE COMPUESTOS ORGANICOS. (COMBINATION OF ORGANIC COMPOUNDS.) | ⤷ Sign Up |
| Malaysia | 146868 | SOLID ORAL DOSAGE FORMS OF VALSARTAN | ⤷ Sign Up |
| Norway | 986056 | ⤷ Sign Up | |
| New Zealand | 237126 | SUBSTITUTED BIPHENYLYL ALKYLAMIDES, SULPHONAMIDES AND CARBAMIC ACID ESTER DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS | ⤷ 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 | C970001 | Netherlands | ⤷ Sign Up | 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 |
| 0503785 | C300375 | Netherlands | ⤷ Sign Up | 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 |
| 1507558 | C300528 | Netherlands | ⤷ Sign Up | 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 | 91676 | Luxembourg | ⤷ Sign Up | 91676, EXPIRES: 20160212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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