Details for Patent: 8,591,946
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Which drugs does patent 8,591,946 protect, and when does it expire?
Patent 8,591,946 protects ENVARSUS XR and is included in one NDA.
This patent has thirty-six patent family members in sixteen countries.
Summary for Patent: 8,591,946
| Title: | Modified release compositions comprising tacrolimus |
| Abstract: | A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents. |
| Inventor(s): | Holm; Per (Vanlose, DK) |
| Assignee: | Veloxis Pharmaceuticals A/S (Horsholm, DK) |
| Application Number: | 10/569,862 |
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Patent Claim Types: see list of patent claims | Composition; Formulation; Dosage form; Compound; |
Drugs Protected by US Patent 8,591,946
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Veloxis Pharms Inc | ENVARSUS XR | tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406-001 | Jul 10, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||||
| Veloxis Pharms Inc | ENVARSUS XR | tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406-002 | Jul 10, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||||
| Veloxis Pharms Inc | ENVARSUS XR | tacrolimus | TABLET, EXTENDED RELEASE;ORAL | 206406-003 | Jul 10, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 8,591,946
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| Denmark | 2003-01232 | Aug 29, 2003 |
| Denmark | 2003-01837 | Dec 11, 2003 |
| Denmark | 2004-00079 | Jan 21, 2004 |
| Denmark | 2004-00463 | Mar 23, 2004 |
| Denmark | 2004-00467 | Mar 23, 2004 |
| PCT Information | |||
| PCT Filed | August 30, 2004 | PCT Application Number: | PCT/DK2004/000573 |
| PCT Publication Date: | March 10, 2005 | PCT Publication Number: | WO2005/020993 |
International Family Members for US Patent 8,591,946
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 473003 | ⤷ Try a Trial | |||
| Austria | 531368 | ⤷ Try a Trial | |||
| Australia | 2004267909 | ⤷ Try a Trial | |||
| Australia | 2004267910 | ⤷ Try a Trial | |||
| Brazil | PI0413927 | ⤷ Try a Trial | |||
| Brazil | PI0414000 | ⤷ Try a Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
