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Last Updated: November 2, 2024

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-one 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 206038
Tradename:ORKAMBI
Applicant:Vertex Pharms Inc
Ingredient:ivacaftor; lumacaftor
Patents:21
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206038
Generic Entry Date for 206038*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

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:RXDosage:TABLET;ORALStrength125MG;200MG
Approval Date:Jul 2, 2015TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Dec 4, 2028Product Flag?YSubstance 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
Patent:⤷  Sign UpPatent Expiration:Dec 4, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING A PHARMACEUTICAL COMPOSITION ACCORDING TO CLAIM 2 OF U.S. PATENT NO. 10,597,384, FURTHER COMPRISING IVACAFTOR
Patent:⤷  Sign UpPatent Expiration:Aug 13, 2029Product Flag?YSubstance Flag?Delist Request?

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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 verification 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.