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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. Four 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 have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for EXFORGE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 137 |
| Clinical Trials: | 14 |
| Patent Applications: | 3,360 |
| 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
| Drug Class | Angiotensin 2 Receptor Blocker Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for EXFORGE
Paragraph IV (Patent) Challenges for EXFORGE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-11-26 |
| EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-11-09 |
| EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 2007-10-22 |
| EXFORGE | TABLET;ORAL | amlodipine besylate; valsartan | 021990 | 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 it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-002 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | ||
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | AB | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Novartis | EXFORGE HCT | amlodipine besylate; hydrochlorothiazide; valsartan | TABLET;ORAL | 022314-004 | Apr 30, 2009 | AB | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | ||
| >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 | 021990-004 | Jun 20, 2007 | ⤷ Try it Free | ⤷ Try it Free |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-005 | Jun 20, 2007 | ⤷ Try it Free | ⤷ Try it Free |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-002 | Jun 20, 2007 | ⤷ Try it Free | ⤷ Try it Free |
| Novartis | EXFORGE | amlodipine besylate; valsartan | TABLET;ORAL | 021990-003 | Jun 20, 2007 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXFORGE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Colombia | 4870755 | ⤷ Try it Free |
| South Africa | 9101179 | ⤷ Try it Free |
| Hungary | 219343 | ⤷ Try it Free |
| Luxembourg | 90362 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EXFORGE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1003503 | 05C0048 | France | ⤷ Try it Free | 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 | 12C0033 | France | ⤷ Try it Free | 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: 6167801 20110705 |
| 0443983 | 98C004 | Belgium | ⤷ Try it Free | PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925 |
| 0443983 | CA 2010 00014 | Denmark | ⤷ Try it Free | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
