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Details for Patent: 10,081,621
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Which drugs does patent 10,081,621 protect, and when does it expire?
Patent 10,081,621 protects SYMDEKO (COPACKAGED) and TRIKAFTA (COPACKAGED) and is included in two NDAs.
This patent has thirty-three patent family members in eleven countries.
Summary for Patent: 10,081,621
| Title: | Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide |
| Abstract: | The present invention relates to solid forms of (R)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarbox- amide (Compound 1) in substantially crystalline form (Form A) or amorphous form, pharmaceutical compositions thereof, and methods of treatment therewith. |
| Inventor(s): | Keshavarz-Shokri; Ali (San Diego, CA), Zhang; Beili (San Diego, CA), Alcacio; Tim Edward (San Diego, CA), Lee; Elaine Chungmin (Arlington, MA), Zhang; Yuegang (Wayland, MA), Krawiec; Mariusz (Marlborough, MA) |
| Assignee: | Vertex Pharmaceuticals Incorporated (Boston, MA) |
| Application Number: | 14/676,205 |
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Patent Claim Types: see list of patent claims |
Drugs Protected by US Patent 10,081,621
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-002 | Jun 21, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621 | Start Trial | |||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-002 | Jun 21, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621 | Start Trial | |||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621 | Start 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 |
International Family Members for US Patent 10,081,621
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2011230508 | Start Trial | |||
| Australia | 2016208341 | Start Trial | |||
| Australia | 2018203149 | Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
