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
(1 year, 11 months 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 |
| US11564916 | Pharmaceutical composition and administrations thereof |
Aug, 2029
(4 years from now) | Active |
| US10646481 | 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 |
| 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 |
| 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 |
| 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 |
| US9216969 | Modulators of ATP-binding cassette transporters |
Nov, 2026
(1 year, 11 months from now) | Active |
| US8741933 | Modulators of ATP-binding cassette transporters |
Nov, 2026
(1 year, 11 months from now) | Active |
| US7973038 | Modulators of ATP-binding cassette transporters |
Nov, 2026
(1 year, 11 months 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 31 Jan, 2023 | US11564916 |
| Recordation of Patent Grant Mailed Critical | 31 Jan, 2023 | US11564916 |
| Email Notification Critical | 12 Jan, 2023 | US11564916 |
| Issue Notification Mailed Critical | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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;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 |
| 125MG;200MG | TABLET | Prescription | ORAL |