Alyftrek is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 33 US drug patents filed in 2025 out of which none have expired yet. Alyftrek's patents will be open to challenges from 20 December, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 10, 2043. Details of Alyftrek'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. | |||
| US11873300 | Crystalline forms of CFTR modulators |
Aug, 2040
(15 years from now) | Active |
| US11066417 | Modulators of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators |
Feb, 2039
(13 years from now) | Active |
| US9512079 | Deuterated CFTR potentiators |
May, 2032
(7 years from now) | Active |
| US9181192 | Deuterated CFTR potentiators |
May, 2032
(7 years from now) | Active |
| US8865902 | Deuterated CFTR potentiators |
May, 2032
(7 years from now) | Active |
| US10047053 | Deuterated CFTR potentiators |
May, 2032
(7 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
(1 year, 9 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). | |||
| US12186306 | Methods of treatment for cystic fibrosis |
Jan, 2043
(17 years from now) | Active |
| US11866450 | Modulators of Cystic Fibrosis Transmembrane Conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators |
Feb, 2039
(13 years from now) | Active |
| US11951212 | Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases |
Apr, 2035
(10 years from now) | Active |
| US10206877 | Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases |
Apr, 2035
(10 years from now) | Active |
| US10058546 | Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof |
Jul, 2033
(8 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 |
| 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 |
| 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 |
| 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 |
| US9974781 | Modulators of ATP-binding cassette transporters |
Apr, 2027
(2 years from now) | Active |
| US10022352 | Modulators of ATP-binding cassette transporters |
Apr, 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
(1 year, 9 months 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
(1 year, 9 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
(1 year, 9 months from now) | Active |
| US8354427 | Modulators of ATP-binding cassette transporters |
Jul, 2026
(1 year, 3 months from now) | Active |
| US8629162 | Modulators of ATP-binding cassette transporters |
Jun, 2025
(3 months from now) | Active |
FDA has granted several exclusivities to Alyftrek. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Alyftrek, 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 Alyftrek.
Exclusivity Information
Alyftrek holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Alyftrek's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 20, 2029 |
Several oppositions have been filed on Alyftrek'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 Alyftrek's generic, the next section provides detailed information on ongoing and past EP oppositions related to Alyftrek patents.
Alyftrek's Oppositions Filed in EPO
Alyftrek 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 |
| EP10708442A | Oct, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP15721912A | Feb, 2019 | Generics (U.K.) Limited | 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 Alyftrek 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 Alyftrek's family patents as well as insights into ongoing legal events on those patents.
Alyftrek's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Alyftrek's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 10, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Alyftrek Generics:
There are no approved generic versions for Alyftrek as of now.
About Alyftrek
Alyftrek is a drug owned by Vertex Pharmaceuticals Inc. Alyftrek uses Deutivacaftor; Tezacaftor; Vanzacaftor Calcium as an active ingredient. Alyftrek was launched by Vertex Pharms Inc in 2024.
Approval Date:
Alyftrek was approved by FDA for market use on 20 December, 2024.
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 Alyftrek is 20 December, 2024, its NCE-1 date is estimated to be 20 December, 2028.
Active Ingredient:
Alyftrek uses Deutivacaftor; Tezacaftor; Vanzacaftor Calcium as the active ingredient. Check out other Drugs and Companies using Deutivacaftor; Tezacaftor; Vanzacaftor Calcium ingredient
Dosage:
Alyftrek is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 125MG;50MG;EQ 10MG BASE | TABLET | Prescription | ORAL |
| 50MG;20MG;EQ 4MG BASE | TABLET | Prescription | ORAL |