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.
The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.
Summary for Exforge
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 151 |
Clinical Trials: | 14 |
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 |
Pharmacology for Exforge
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-003 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | ⤷ 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-004 | Jun 20, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Japan | 2012051948 | SOLID ORAL DOSAGE FORM OF VALSARTAN | ⤷ Try a Trial |
Germany | 19675036 | ⤷ Try a Trial | |
Norway | 317181 | ⤷ Try a Trial | |
South Africa | 9101179 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Exforge
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | 97C0039 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 |
0678503 | C300499 | Netherlands | ⤷ Try a Trial | 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 |
1003503 | 05C0048 | France | ⤷ Try a 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |