Symdeko (copackaged) is a drug owned by Vertex Pharmaceuticals Inc. It is protected by 25 US drug patents filed from 2018 to 2024 out of which none have expired yet. Symdeko (Copackaged)'s patents have been open to challenges since 12 February, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 14, 2035. Details of Symdeko (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. | |||
| 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 |
| US8623905 | 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 |
| US11639347 | Modulators of ATP-binding cassette transporters |
Apr, 2027
(2 years from now) | Active |
| US10239867 | 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). | |||
| 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 |
| 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 |
| 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 |
| 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 |
| 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
(7 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 Symdeko (copackaged)'s patents.
Latest Legal Activities on Symdeko (copackaged)'s Patents
Given below is the list of recent legal activities going on the following patents of Symdeko (copackaged).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 09 Apr, 2024 | US11951212 |
| Patent eGrant Notification | 09 Apr, 2024 | US11951212 |
| Recordation of Patent eGrant | 09 Apr, 2024 | US11951212 |
| Mail Patent eGrant Notification | 09 Apr, 2024 | US11951212 |
| Email Notification Critical | 09 Apr, 2024 | US11951212 |
| Recordation of Patent Grant Mailed Critical | 09 Apr, 2024 | US11951212 |
| Email Notification Critical | 21 Mar, 2024 | US11951212 |
| Issue Notification Mailed Critical | 20 Mar, 2024 | US11951212 |
| Dispatch to FDC | 05 Mar, 2024 | US11951212 |
| Application Is Considered Ready for Issue Critical | 05 Mar, 2024 | US11951212 |
FDA has granted several exclusivities to Symdeko (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Symdeko (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 Symdeko (copackaged).
Exclusivity Information
Symdeko (copackaged) holds 5 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Symdeko (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Jun 21, 2022 |
| New Chemical Entity Exclusivity(NCE) | Feb 12, 2023 |
| Orphan Drug Exclusivity(ODE-173) | Feb 12, 2025 |
| Orphan Drug Exclusivity(ODE-247) | Jun 21, 2026 |
| Orphan Drug Exclusivity(ODE-335) | Dec 21, 2027 |
Several oppositions have been filed on Symdeko (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 Symdeko (copackaged)'s generic, the next section provides detailed information on ongoing and past EP oppositions related to Symdeko (copackaged) patents.
Symdeko (copackaged)'s Oppositions Filed in EPO
Symdeko (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 |
| 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 Symdeko (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 Symdeko (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Symdeko (copackaged)'s Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Symdeko (copackaged)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 14, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Symdeko (copackaged) Generics:
There are no approved generic versions for Symdeko (copackaged) as of now.
About Symdeko (copackaged)
Symdeko (Copackaged) is a drug owned by Vertex Pharmaceuticals Inc. It is used for treating cystic fibrosis in patients with specific CFTR mutations, aged 6 and older. Symdeko (Copackaged) uses Ivacaftor; Ivacaftor, Tezacaftor as an active ingredient. Symdeko (Copackaged) was launched by Vertex Pharms Inc in 2019.
Approval Date:
Symdeko (copackaged) was approved by FDA for market use on 21 June, 2019.
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 Symdeko (copackaged) is 21 June, 2019, its NCE-1 date is estimated to be 12 February, 2022.
Active Ingredient:
Symdeko (copackaged) uses Ivacaftor; Ivacaftor, Tezacaftor as the active ingredient. Check out other Drugs and Companies using Ivacaftor; Ivacaftor, Tezacaftor ingredient
Treatment:
Symdeko (copackaged) is used for treating cystic fibrosis in patients with specific CFTR mutations, aged 6 and older.
Dosage:
Symdeko (copackaged) is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG;150MG, 100MG | TABLET | Prescription | ORAL |
| 75MG;75MG, 50MG | TABLET | Prescription | ORAL |