Orkambi Patent Expiration

Orkambi is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 22 US drug patents filed from 2015 to 2024 out of which none have expired yet. Orkambi's patents have been open to challenges since 02 January, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2030. Details of Orkambi's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8507534 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Sep, 2030

(5 years from now)

Active
US10597384 Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Dec, 2028

(4 years from now)

Active
US7495103 Modulators of ATP-binding cassette transporters
May, 2027

(2 years from now)

Active
US8754224 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(2 years from now)

Active
US9216969 Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8993600 Modulators of ATP-binding cassette transporters
Dec, 2030

(6 years from now)

Active
US8716338 Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Sep, 2030

(5 years from now)

Active
US9192606 Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Sep, 2029

(4 years from now)

Active
US10646481 Pharmaceutical composition and administrations thereof
Aug, 2029

(4 years from now)

Active
US11564916 Pharmaceutical composition and administrations thereof
Aug, 2029

(4 years from now)

Active
US8846718 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxo1-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Jul, 2029

(4 years from now)

Active
US9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Dec, 2028

(4 years from now)

Active
US10076513 Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Dec, 2028

(4 years from now)

Active
US12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid
Dec, 2028

(4 years from now)

Active
US11052075 Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof
Dec, 2028

(4 years from now)

Active
US8653103 Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Dec, 2028

(4 years from now)

Active
US8324242 Modulators of ATP-binding cassette transporters
Aug, 2027

(2 years from now)

Active
US8410274 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(2 years from now)

Active
US9670163 Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(2 years from now)

Active
US9931334 Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide
Dec, 2026

(2 years from now)

Active
US8741933 Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

Active
US9216969 Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

Active
US7973038 Modulators of ATP-binding cassette transporters
Nov, 2026

(2 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Orkambi's patents.

Given below is the list of recent legal activities going on the following patents of Orkambi.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 04 Jun, 2024 US8324242 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 13 Nov, 2023 US10646481
Payment of Maintenance Fee, 4th Year, Large Entity 25 Sep, 2023 US10597384
Payment of Maintenance Fee, 8th Year, Large Entity 22 Jun, 2023 US9216969
Payment of Maintenance Fee, 8th Year, Large Entity 24 May, 2023 US9192606
Payment of Maintenance Fee, 8th Year, Large Entity 06 Apr, 2023 US9150552
Patent Issue Date Used in PTA Calculation 31 Jan, 2023 US11564916
Recordation of Patent Grant Mailed 31 Jan, 2023 US11564916
Email Notification 12 Jan, 2023 US11564916
Issue Notification Mailed 11 Jan, 2023 US11564916


FDA has granted several exclusivities to Orkambi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orkambi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Orkambi.

Exclusivity Information

Orkambi holds 12 exclusivities out of which 8 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Orkambi's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Sep 02, 2025
Pediatric Exclusivity(PED) Jan 02, 2023
New Chemical Entity Exclusivity(NCE) Jul 02, 2020
M(M-218) Jan 25, 2021
New Product(NP) Aug 07, 2021
Orphan Drug Exclusivity(ODE-93) Jul 02, 2022
Orphan Drug Exclusivity(ODE) Sep 28, 2023
Orphan Drug Exclusivity(ODE-123) Sep 28, 2023
Orphan Drug Exclusivity(ODE-195) Aug 07, 2025
New Strength(NS) Sep 02, 2025
Generating Antibiotic Incentives Now(GAIN) Jan 02, 2028
Orphan Drug Exclusivity(ODE-408) Sep 02, 2029

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Several oppositions have been filed on Orkambi's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Orkambi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Orkambi patents.

Orkambi's Oppositions Filed in EPO

Orkambi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 18, 2017, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP11715637A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP17204189A Sep, 2021 STADA Arzneimittel AG Granted and Under Opposition
EP17204189A Sep, 2021 Lederer & Keller Patentanwälte Partnerschaft mbB Granted and Under Opposition
EP17204189A Sep, 2021 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP10708442A Oct, 2019 Teva Pharmaceutical Industries Ltd Granted and Under Opposition
EP06848237A Nov, 2017 Georg Kalhammer/Stephan Teipel Opposition rejected
EP11715637A May, 2017 Alfred E. Tiefenbacher (GmbH & Co. KG) Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Orkambi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Orkambi's family patents as well as insights into ongoing legal events on those patents.

Orkambi's Family Patents

Orkambi has patent protection in a total of 35 countries. It's US patent count contributes only to 24.3% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Orkambi.

Family Patents

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Generic Launch

Generic Release Date:

Orkambi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Orkambi Generics:

There are no approved generic versions for Orkambi as of now.





About Orkambi

Orkambi is a drug owned by Vertex Pharmaceuticals Inc. It is used for treating cystic fibrosis in patients with the F508DEL mutation in the CFTR gene. Orkambi uses Ivacaftor; Lumacaftor as an active ingredient. Orkambi was launched by Vertex Pharms Inc in 2016.

Approval Date:

Orkambi was approved by FDA for market use on 28 September, 2016.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Orkambi is 28 September, 2016, its NCE-1 date is estimated to be 02 January, 2022.

Active Ingredient:

Orkambi uses Ivacaftor; Lumacaftor as the active ingredient. Check out other Drugs and Companies using Ivacaftor; Lumacaftor ingredient

Treatment:

Orkambi is used for treating cystic fibrosis in patients with the F508DEL mutation in the CFTR gene.

Dosage:

Orkambi is available in the following dosage forms - tablet form for oral use, granule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
125MG;200MG TABLET Prescription ORAL
125MG;100MG TABLET Prescription ORAL
125MG/PACKET;100MG/PACKET GRANULE Prescription ORAL
94MG/PACKET;75MG/PACKET GRANULE Prescription ORAL
188MG/PACKET;150MG/PACKET GRANULE Prescription ORAL


Orkambi News

Cystic fibrosis patients urge DPIIT to permit domestic production of CFTR modulators for accessibility

03 Feb, 2024

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