FLOLIPID Drug Patent Profile
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Which patents cover Flolipid, and what generic alternatives are available?
Flolipid is a drug marketed by Salerno Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has twelve patent family members in twelve countries.
The generic ingredient in FLOLIPID is simvastatin. There are forty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Flolipid
A generic version of FLOLIPID was approved as simvastatin by AUROBINDO PHARMA on December 20th, 2006.
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Questions you can ask:
- What is the 5 year forecast for FLOLIPID?
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Summary for FLOLIPID
| International Patents: | 12 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Drug Prices: | Drug price information for FLOLIPID |
| What excipients (inactive ingredients) are in FLOLIPID? | FLOLIPID excipients list |
| DailyMed Link: | FLOLIPID at DailyMed |
Pharmacology for FLOLIPID
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
US Patents and Regulatory Information for FLOLIPID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Salerno Pharms | FLOLIPID | simvastatin | SUSPENSION;ORAL | 206679-001 | Apr 21, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salerno Pharms | FLOLIPID | simvastatin | SUSPENSION;ORAL | 206679-002 | Apr 21, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salerno Pharms | FLOLIPID | simvastatin | SUSPENSION;ORAL | 206679-001 | Apr 21, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Salerno Pharms | FLOLIPID | simvastatin | SUSPENSION;ORAL | 206679-002 | Apr 21, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for FLOLIPID
See the table below for patents covering FLOLIPID around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 2018153 | ⤷ Sign Up | |
| Japan | 2009534459 | ⤷ Sign Up | |
| European Patent Office | 2018153 | COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS) | ⤷ Sign Up |
| Spain | 2385752 | ⤷ Sign Up | |
| Australia | 2007245410 | Liquid oral compositions | ⤷ Sign Up |
| China | 101431982 | Liquid oral compositions | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2007125339 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FLOLIPID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0720599 | 05C0040 | France | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402 |
| 0720599 | 26/2005 | Austria | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402 |
| 0720599 | C300172 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402 |
| 0720599 | SPC/GB05/010 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411 |
| 0720599 | 122004000026 | Germany | ⤷ Sign Up | PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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