Kalydeco is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 13 US drug patents filed from 2015 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 27, 2033. Details of Kalydeco's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| 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 |
| US7495103 | Modulators of ATP-binding cassette transporters |
May, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8629162 | Modulators of ATP-binding cassette transporters |
Jun, 2025
(10 months from now) | Active |
| US8354427 | Modulators of ATP-binding cassette transporters |
Jul, 2026
(1 year, 11 months 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 |
| 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 |
| US8324242 | Modulators of ATP-binding cassette transporters |
Aug, 2027
(3 years from now) | Active |
| US10646481 | Pharmaceutical composition and administrations thereof |
Aug, 2029
(5 years from now) | Active |
| US11564916 | Pharmaceutical composition and administrations thereof |
Aug, 2029
(5 years from now) | Active |
| US11752106 | Pharmaceutical composition and administrations thereof |
Feb, 2033
(8 years from now) | Active |
| US11147770 | Pharmaceutical composition and administrations thereof |
Feb, 2033
(8 years from now) | Active |
| US10272046 | Pharmaceutical composition and administrations thereof |
Feb, 2033
(8 years from now) | Active |
| US8883206 | Pharmaceutical composition and administrations thereof |
Feb, 2033
(8 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 Kalydeco's patents.
Latest Legal Activities on Kalydeco's Patents
Given below is the list of recent legal activities going on the following patents of Kalydeco.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Jul, 2024 | US8354427 |
| 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 |
| Patent Issue Date Used in PTA Calculation | 12 Sep, 2023 | US11752106 |
| Email Notification | 12 Sep, 2023 | US11752106 |
| Patent eGrant Notification | 12 Sep, 2023 | US11752106 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11752106 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11752106 |
| Recordation of Patent Grant Mailed | 12 Sep, 2023 | US11752106 |
| Email Notification | 24 Aug, 2023 | US11752106 |
FDA has granted several exclusivities to Kalydeco. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kalydeco, 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 Kalydeco.
Exclusivity Information
Kalydeco holds 12 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Kalydeco's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 31, 2017 |
| New Indication(I-740) | Feb 21, 2017 |
| Orphan Drug Exclusivity(ODE-20) | Jan 31, 2019 |
| Orphan Drug Exclusivity(ODE) | Jan 31, 2019 |
| Orphan Drug Exclusivity(ODE-188) | Mar 17, 2022 |
| New Patient Population(NPP) | May 03, 2026 |
| Orphan Drug Exclusivity(ODE-190) | May 17, 2024 |
| Orphan Drug Exclusivity(ODE-189) | Jul 31, 2024 |
| Orphan Drug Exclusivity(ODE-199) | Aug 15, 2025 |
| Orphan Drug Exclusivity(ODE-236) | Apr 29, 2026 |
| Orphan Drug Exclusivity(ODE-338) | Dec 21, 2027 |
| Orphan Drug Exclusivity(ODE-435) | May 03, 2030 |
Several oppositions have been filed on Kalydeco'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 Kalydeco's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kalydeco patents.
Kalydeco's oppositions filed in EPO
Kalydeco has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 03, 2017, by Georg Kalhammer/Stephan Teipel. This opposition was filed on patent number EP06848237A. 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 PatentanwƤlte 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 |
US patents provide insights into the exclusivity only within the United States, but Kalydeco 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 Kalydeco's family patents as well as insights into ongoing legal events on those patents.
Kalydeco's family patents
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Generic Launch
Generic Release Date:
Kalydeco's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 27, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kalydeco Generics:
There are no approved generic versions for Kalydeco as of now.
How can I launch a generic of Kalydeco before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kalydeco's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kalydeco's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Kalydeco -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg | 10 Jun, 2020 | 1 | 13 Aug, 2029 | ||
| 25 mg, 50 mg and 75 mg | 13 Apr, 2022 | 1 | 27 Feb, 2033 |
About Kalydeco
Kalydeco is a drug owned by Vertex Pharmaceuticals Inc. It is used for treating Cystic Fibrosis by targeting specific CFTR mutations with Ivacaftor treatment. Kalydeco uses Ivacaftor as an active ingredient. Kalydeco was launched by Vertex Pharms Inc in 2023.
Market Authorisation Date:
Kalydeco was approved by FDA for market use on 03 May, 2023.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Kalydeco is 03 May, 2023, its NCE-1 date is estimated to be 01 February, 2016
Active Ingredient:
Kalydeco uses Ivacaftor as the active ingredient. Check out other Drugs and Companies using Ivacaftor ingredient
Treatment:
Kalydeco is used for treating Cystic Fibrosis by targeting specific CFTR mutations with Ivacaftor treatment.
Dosage:
Kalydeco is available in granule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5.8MG/PACKET | GRANULE | Prescription | ORAL |
| 50MG/PACKET | GRANULE | Prescription | ORAL |
| 25MG/PACKET | GRANULE | Prescription | ORAL |
| 75MG/PACKET | GRANULE | Prescription | ORAL |
| 13.4MG/PACKET | GRANULE | Prescription | ORAL |
Kalydeco is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2013 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 13, 2029. Details of Kalydeco's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| 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 |
| US7495103 | Modulators of ATP-binding cassette transporters |
May, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8629162 | Modulators of ATP-binding cassette transporters |
Jun, 2025
(10 months from now) | Active |
| US8354427 | Modulators of ATP-binding cassette transporters |
Jul, 2026
(1 year, 11 months 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 |
| 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 |
| US8324242 | Modulators of ATP-binding cassette transporters |
Aug, 2027
(3 years from now) | Active |
| US10646481 | Pharmaceutical composition and administrations thereof |
Aug, 2029
(5 years from now) | Active |
| US11564916 | Pharmaceutical composition and administrations thereof |
Aug, 2029
(5 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 Kalydeco's patents.
Latest Legal Activities on Kalydeco's Patents
Given below is the list of recent legal activities going on the following patents of Kalydeco.
| Event | Date | Patent/Publication |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Jul, 2024 | US8354427 |
| 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 |
| Patent Issue Date Used in PTA Calculation | 12 Sep, 2023 | US11752106 |
| Email Notification | 12 Sep, 2023 | US11752106 |
| Patent eGrant Notification | 12 Sep, 2023 | US11752106 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11752106 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11752106 |
| Recordation of Patent Grant Mailed | 12 Sep, 2023 | US11752106 |
| Email Notification | 24 Aug, 2023 | US11752106 |
FDA has granted several exclusivities to Kalydeco. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kalydeco, 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 Kalydeco.
Exclusivity Information
Kalydeco holds 12 exclusivities out of which 9 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Kalydeco's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 31, 2017 |
| New Indication(I-740) | Feb 21, 2017 |
| New Indication(I-705) | Dec 30, 2017 |
| Orphan Drug Exclusivity(ODE-20) | Jan 31, 2019 |
| Orphan Drug Exclusivity(ODE) | Jan 31, 2019 |
| New Patient Population(NPP) | Jul 31, 2020 |
| Orphan Drug Exclusivity(ODE-186) | Feb 21, 2021 |
| Orphan Drug Exclusivity(ODE-187) | Dec 29, 2021 |
| Orphan Drug Exclusivity(ODE-190) | May 17, 2024 |
| Orphan Drug Exclusivity(ODE-189) | Jul 31, 2024 |
| Orphan Drug Exclusivity(ODE-199) | Aug 15, 2025 |
| Orphan Drug Exclusivity(ODE-338) | Dec 21, 2027 |
Several oppositions have been filed on Kalydeco'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 Kalydeco's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kalydeco patents.
Kalydeco's oppositions filed in EPO
Kalydeco has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 03, 2017, by Georg Kalhammer/Stephan Teipel. This opposition was filed on patent number EP06848237A. 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 PatentanwƤlte 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 |
US patents provide insights into the exclusivity only within the United States, but Kalydeco 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 Kalydeco's family patents as well as insights into ongoing legal events on those patents.
Kalydeco's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response š„³
Generic Launch
Generic Release Date:
Kalydeco's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 13, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kalydeco Generics:
There are no approved generic versions for Kalydeco as of now.
How can I launch a generic of Kalydeco before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kalydeco's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kalydeco's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Kalydeco -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg | 10 Jun, 2020 | 1 | 13 Aug, 2029 | ||
| 25 mg, 50 mg and 75 mg | 13 Apr, 2022 | 1 | 27 Feb, 2033 |
About Kalydeco
Kalydeco is a drug owned by Vertex Pharmaceuticals Inc. It is used for treating Cystic Fibrosis by targeting specific CFTR mutations with Ivacaftor treatment. Kalydeco uses Ivacaftor as an active ingredient. Kalydeco was launched by Vertex Pharms in 2019.
Market Authorisation Date:
Kalydeco was approved by FDA for market use on 20 May, 2019.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Kalydeco is 20 May, 2019, its NCE-1 date is estimated to be 01 February, 2016
Active Ingredient:
Kalydeco uses Ivacaftor as the active ingredient. Check out other Drugs and Companies using Ivacaftor ingredient
Treatment:
Kalydeco is used for treating Cystic Fibrosis by targeting specific CFTR mutations with Ivacaftor treatment.
Dosage:
Kalydeco is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |