LESCOL Drug Patent Profile
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When do Lescol patents expire, and what generic alternatives are available?
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 |
|---|---|
| Brigham and Women's Hospital | Phase 4 |
| Amgen | 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 | 020261-002 | 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 | 020261-001 | 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 |
|---|---|---|---|
| Austria | A190595 | ⤷ 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 |
| Finland | 77228 | ⤷ Try a Trial | |
| Norway | 302099 | ⤷ Try a Trial | |
| Czech Republic | 287776 | Stabilizovaný farmaceutický prostředek (Stabilized pharmaceutical preparation) | ⤷ 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 | 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 |
| 0114027 | SPC/GB93/173 | United Kingdom | ⤷ Try a Trial | SPC/GB93/173: 20031122, EXPIRES: 20080822 |
| >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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