LESCOL XL Drug Patent Profile
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When do Lescol Xl patents expire, and when can generic versions of Lescol Xl launch?
Lescol Xl is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in LESCOL XL 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 Xl
A generic version of LESCOL XL was approved as fluvastatin sodium by MYLAN PHARMS INC on April 11th, 2012.
Summary for LESCOL XL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 134 |
| Clinical Trials: | 11 |
| Patent Applications: | 3,776 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LESCOL XL |
| What excipients (inactive ingredients) are in LESCOL XL? | LESCOL XL excipients list |
| DailyMed Link: | LESCOL XL at DailyMed |
Recent Clinical Trials for LESCOL XL
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 |
Pharmacology for LESCOL XL
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LESCOL XL
Paragraph IV (Patent) Challenges for LESCOL XL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LESCOL XL | Extended-release Tablets | fluvastatin sodium | 80 mg | 021192 | 1 | 2007-03-15 |
US Patents and Regulatory Information for LESCOL XL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | 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 XL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | LESCOL XL | fluvastatin sodium | TABLET, EXTENDED RELEASE;ORAL | 021192-001 | Oct 6, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LESCOL XL
See the table below for patents covering LESCOL XL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 25597 | Pharmaceutical compositions of pH at least 8 comprising an HMG-CoA reductase inhibitor | ⤷ Try a Trial |
| Australia | 661075 | ⤷ Try a Trial | |
| Denmark | 97890 | ⤷ Try a Trial | |
| Hungary | 204253 | PROCESS FOR PRODUCING MEVALONOLACTONE ANALOGUES AND DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM | ⤷ Try a Trial |
| Finland | 77228 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LESCOL XL
| 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
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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.
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