LESCOL Drug Patent Profile
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When do Lescol patents expire, and when can generic versions of Lescol launch?
Lescol is a drug marketed by Novartis and Sandoz and is included in two NDAs.
The generic ingredient in LESCOL is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lescol
A generic version of LESCOL was approved as fluvastatin sodium by MYLAN PHARMS INC on April 11th, 2012.
Summary for LESCOL
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 11 |
Patent Applications: | 6,055 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LESCOL |
What excipients (inactive ingredients) are in LESCOL? | LESCOL excipients list |
DailyMed Link: | LESCOL at DailyMed |
Recent Clinical Trials for LESCOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amgen | Phase 4 |
Brigham and Women's Hospital | Phase 4 |
University of California, San Francisco | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for LESCOL
Paragraph IV (Patent) Challenges for LESCOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LESCOL | Capsules | fluvastatin sodium | 20 mg and 40 mg | 020261 | 1 | 2008-06-04 |
US Patents and Regulatory Information for LESCOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-002 | Dec 31, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | AB | RX | Yes | Yes | ⤷ 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 LESCOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-002 | Dec 31, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-001 | Dec 31, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | LESCOL | fluvastatin sodium | CAPSULE;ORAL | 020261-002 | Dec 31, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LESCOL
See the table below for patents covering LESCOL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Czech Republic | 9203633 | ⤷ Try a Trial | |
Spain | 8506622 | ⤷ Try a Trial | |
Cyprus | 1994 | Pharmaceutical compositions of pH at least 8 comprising an HMG-CoA reductase inhibitor | ⤷ Try a Trial |
Hong Kong | 11191 | ANALOGS OF MEVALOLACTONE AND DERIVATIVES THEREOF,PROCESSES FOR THEIR PRODUCTION,PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE AS PHARMACEUTICALS | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LESCOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0114027 | SPC/GB93/173 | United Kingdom | ⤷ Try a Trial | SPC/GB93/173: 20031122, EXPIRES: 20080822 |
0114027 | 96C0022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |