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.
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): | Young; Christopher (Waltham, MA) |
Assignee: | Vertex Pharmaceuticals Incorporated (Boston, MA) |
Application Number: | 12/568,717 |
Patent Claim Types: see list of patent claims | Compound; Dosage form; Composition; Use; Device; |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR | ⤷ Try a Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-001 | Aug 7, 2018 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR | ⤷ Try a Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | GRANULE;ORAL | 211358-002 | Aug 7, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 8716338 AND IVACAFTOR | ⤷ Try a Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-002 | Sep 28, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338 | ⤷ Try a Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | METHOD OF TREATING CYSTIC FIBROSIS IN PATIENTS WHO HAVE THE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE. | ⤷ Try a Trial | |||
Vertex Pharms Inc | ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038-001 | Jul 2, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING THE DOSAGE UNIT OF CLAIM 1 OF U.S. PATENT NO. 8,716,338 | ⤷ 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 |
International Family Members for US Patent 8,716,338
Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
---|---|---|---|---|---|
Argentina | 073709 | ⤷ Try a Trial | |||
Australia | 2009296271 | ⤷ Try a Trial | |||
Brazil | PI0919550 | ⤷ Try a Trial | |||
Canada | 2736545 | ⤷ Try a Trial | |||
Chile | 2011000642 | ⤷ Try a Trial | |||
China | 102164587 | ⤷ Try a Trial | |||
>Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |