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Serving 500+ biopharmaceutical companies globally:

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Generated: July 28, 2017

DrugPatentWatch Database Preview

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 one NDA. It is available from one supplier. There are fifteen 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.

Summary for NDA: 206038

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:15

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG;200MG
Approval Date:Jul 2, 2015TE:RLD:Yes
Patent:► SubscribePatent Expiration:May 20, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Nov 8, 2026Product Flag?Substance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Aug 5, 2027Product Flag?Substance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
US Department of Justice
Baxter
Deloitte
Moodys
Boehringer Ingelheim
Farmers Insurance
Julphar
McKinsey
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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