Symdeko (copackaged) Patent Expiration

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
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
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).
US10206877 Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Apr, 2035

(10 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
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
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

(3 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, 8 months from now)

Active
US8629162 Modulators of ATP-binding cassette transporters
Jun, 2025

(8 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.

Given below is the list of recent legal activities going on the following patents of Symdeko (copackaged).

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 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 09 Apr, 2024 US11951212
Recordation of Patent Grant Mailed 09 Apr, 2024 US11951212
Email Notification 21 Mar, 2024 US11951212
Issue Notification Mailed 20 Mar, 2024 US11951212
Dispatch to FDC 05 Mar, 2024 US11951212
Application Is Considered Ready for Issue 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

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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
Patent litigations
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

Symdeko (copackaged) has patent protection in a total of 37 countries. It's US patent count contributes only to 22.5% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Symdeko (copackaged).

Family Patents

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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