Details for New Drug Application (NDA): 206038
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NDA 206038 describes ORKAMBI, which is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty patents protecting this drug. Additional details are available on the ORKAMBI profile page.
The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.
The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.
Summary for 206038
| Tradename: | ORKAMBI |
| Applicant: | Vertex Pharms Inc |
| Ingredient: | ivacaftor; lumacaftor |
| Patents: | 20 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 206038
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 206038
Suppliers and Packaging for NDA: 206038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-700 | 51167-700-02 | 4 CARTON in 1 BOX (51167-700-02) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK |
| ORKAMBI | ivacaftor; lumacaftor | TABLET;ORAL | 206038 | NDA | Vertex Pharmaceuticals Incorporated | 51167-809 | 51167-809-01 | 4 CARTON in 1 BOX (51167-809-01) / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG;200MG | ||||
| Approval Date: | Jul 2, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 28, 2023 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE | ||||||||
| Regulatory Exclusivity Expiration: | Jul 2, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR F508DEL MUTATION IN THE CFTR GENE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 12 YEARS OR OLDER WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE TABLET COMPRISING LUMACAFTOR AS RECITED IN CLAIM 1, 19, OR 21 OF U.S. PATENT NO. 10,076,513 AND IVACAFTOR | ||||||||
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