Details for Patent: 8,716,338
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Which drugs does patent 8,716,338 protect, and when does it expire?
Patent 8,716,338 protects ORKAMBI and is included in two NDAs.
Protection for ORKAMBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has thirteen patent family members in thirteen countries.
Summary for Patent: 8,716,338
| Title: | Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
| Abstract: | The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith. |
| Inventor(s): | Christopher Young |
| Assignee: | Vertex Pharmaceuticals Inc |
| Application Number: | US12/568,717 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,716,338 |
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Patent Claim Types: see list of patent claims | Use; Composition; Device; Dosage form; |
Drugs Protected by US Patent 8,716,338
| 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 | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-003 | Sep 2, 2022 | RX | Yes | No | 8,716,338*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-001 | Aug 7, 2018 | RX | Yes | No | 8,716,338*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-002 | Aug 7, 2018 | RX | Yes | Yes | 8,716,338*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | 8,716,338*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||||
| Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | 8,716,338*PED | ⤷ Start Trial | Y | ⤷ 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 8,716,338
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 073709 | ⤷ Start Trial | |||
| Australia | 2009296271 | ⤷ Start Trial | |||
| Brazil | PI0919550 | ⤷ Start Trial | |||
| Canada | 2736545 | ⤷ Start Trial | |||
| Chile | 2011000642 | ⤷ Start Trial | |||
| China | 102164587 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
