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Details for Patent: 10,081,621
Which drugs does patent 10,081,621 protect, and when does it expire?
Patent 10,081,621 protects SYMDEKO (COPACKAGED) and is included in one NDA.
This patent has thirty 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 |
|
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 | 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 | |||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET, TABLET;ORAL | 210491-002 | Jun 21, 2019 | RX | Yes | Yes | 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 |
