Trikafta (copackaged) is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 32 US drug patents filed from 2019 to 2023 out of which none have expired yet. Trikafta (Copackaged)'s patents have been open to challenges since 22 October, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 08, 2037. Details of Trikafta (copackaged)'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. | |||
| US11453655 | Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator |
Dec, 2037
(13 years from now) | Active |
| US10793547 | Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator |
Dec, 2037
(13 years from now) | Active |
| US11426407 | Modulators of cystic fibrosis transmembrane conductance regulator |
Oct, 2035
(10 years from now) | Active |
| US10758534 | NA |
Oct, 2035
(10 years from now) | Active |
| US7776905 | Modulators of ATP-binding cassette transporters |
Jun, 2027
(2 years from now) | Active |
| US7495103 | Modulators of ATP-binding cassette transporters |
May, 2027
(2 years from now) | Active |
| US7645789 | Indole derivatives as CFTR modulators |
May, 2027
(2 years from now) | Active |
| US8623905 | Modulators of ATP-binding cassette transporters |
May, 2027
(2 years from now) | Active |
| US10239867 | Modulators of ATP-binding cassette transporters |
Apr, 2027
(2 years from now) | Active |
| US11639347 | Modulators of ATP-binding cassette transporters |
Apr, 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 |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11517564 | Methods of treatment for cystic fibrosis |
Dec, 2037
(13 years from now) | Active |
| US11179367 | Pharmaceutical compositions for treating cystic fibrosis |
Dec, 2037
(13 years from now) | Active |
| US9012496 | Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof |
Jul, 2033
(8 years from now) | Active |
| US10272046 | Pharmaceutical composition and administrations thereof |
Feb, 2033
(8 years from now) | Active |
| US11752106 | 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 |
| US11147770 | Pharmaceutical composition and administrations thereof |
Feb, 2033
(8 years from now) | Active |
| US10081621 | Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide |
Mar, 2031
(6 years from now) | Active |
| US11578062 | Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide |
Mar, 2031
(6 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 |
| US8415387 | Modulators of ATP-binding cassette transporters |
Nov, 2027
(2 years from now) | Active |
| US8324242 | Modulators of ATP-binding cassette transporters |
Aug, 2027
(2 years from now) | Active |
| US8598181 | Modulators of ATP-binding cassette transporters |
May, 2027
(2 years from now) | Active |
| US10022352 | Modulators of ATP-binding cassette transporters |
Apr, 2027
(2 years from now) | Active |
| US9974781 | Modulators of ATP-binding cassette transporters |
Apr, 2027
(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 |
| 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 |
| US8354427 | Modulators of ATP-binding cassette transporters |
Jul, 2026
(1 year, 7 months from now) | Active |
| US8629162 | Modulators of ATP-binding cassette transporters |
Jun, 2025
(6 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 Trikafta (copackaged)'s patents.
Latest Legal Activities on Trikafta (copackaged)'s Patents
Given below is the list of recent legal activities going on the following patents of Trikafta (copackaged).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Apr, 2024 | US10793547 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Mar, 2024 | US10758534 |
| Electronic Review Critical | 24 May, 2023 | US11578062 |
| Post Issue Communication - Certificate of Correction | 05 May, 2023 | US11578062 |
| Electronic Review Critical | 03 May, 2023 | US11639347 |
| Email Notification Critical | 03 May, 2023 | US11639347 |
| Patent Issue Date Used in PTA Calculation Critical | 02 May, 2023 | US11639347 |
| Miscellaneous Communication to Applicant - No Action Count | 02 May, 2023 | US11639347 |
| Mail Miscellaneous Communication to Applicant | 02 May, 2023 | US11639347 |
| Recordation of Patent eGrant | 02 May, 2023 | US11639347 |
FDA has granted several exclusivities to Trikafta (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Trikafta (copackaged), 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 Trikafta (copackaged).
Exclusivity Information
Trikafta (copackaged) holds 7 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Trikafta (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 08, 2024 |
| New Chemical Entity Exclusivity(NCE) | Oct 21, 2024 |
| New Product(NP) | Apr 26, 2026 |
| Orphan Drug Exclusivity(ODE-275) | Oct 21, 2026 |
| Orphan Drug Exclusivity(ODE-323) | Dec 21, 2027 |
| Orphan Drug Exclusivity(ODE-357) | Jun 08, 2028 |
| Orphan Drug Exclusivity(ODE-433) | Apr 26, 2030 |
Several oppositions have been filed on Trikafta (copackaged)'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 Trikafta (copackaged)'s generic, the next section provides detailed information on ongoing and past EP oppositions related to Trikafta (copackaged) patents.
Trikafta (copackaged)'s Oppositions Filed in EPO
Trikafta (copackaged) 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 Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
| EP17204189A | Sep, 2021 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP15849396A | May, 2021 | Generics [UK] Limited | 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 Trikafta (copackaged) 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 Trikafta (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Trikafta (copackaged)'s Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trikafta (copackaged)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 08, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trikafta (copackaged) Generics:
There are no approved generic versions for Trikafta (copackaged) as of now.
About Trikafta (copackaged)
Trikafta (Copackaged) is a drug owned by Vertex Pharmaceuticals Inc. It is used for treating cystic fibrosis in patients with specific genetic mutations. Trikafta (Copackaged) uses Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor as an active ingredient. Trikafta (Copackaged) was launched by Vertex Pharms Inc in 2021.
Approval Date:
Trikafta (copackaged) was approved by FDA for market use on 08 June, 2021.
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 Trikafta (copackaged) is 08 June, 2021, its NCE-1 date is estimated to be 22 October, 2023.
Active Ingredient:
Trikafta (copackaged) uses Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor as the active ingredient. Check out other Drugs and Companies using Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor ingredient
Treatment:
Trikafta (copackaged) is used for treating cystic fibrosis in patients with specific genetic mutations.
Dosage:
Trikafta (copackaged) is available in the following dosage forms - granules form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG,37.5MG,25MG; 75MG | TABLET | Prescription | ORAL |
| 80MG, 60MG, 40MG;59.5MG | GRANULES | Prescription | ORAL |
| 100MG, 75MG, 50MG;75MG | GRANULES | Prescription | ORAL |
| 100MG,75MG,50MG; 150MG | TABLET | Prescription | ORAL |