SYMDEKO (COPACKAGED) Drug Patent Profile
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Which patents cover Symdeko (copackaged), and what generic alternatives are available?
Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty-five patents protecting this drug.
This drug has four hundred and sixteen patent family members in thirty-nine countries.
The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.
DrugPatentWatch® Generic Entry Outlook for Symdeko (copackaged)
Symdeko (copackaged) was eligible for patent challenges on February 12, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 14, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for SYMDEKO (COPACKAGED)
| International Patents: | 416 |
| US Patents: | 25 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | SYMDEKO (COPACKAGED) at DailyMed |
-patent-expirations.png "SYMDEKO (COPACKAGED) drug patent expirations")
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SYMDEKO (COPACKAGED)
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for SYMDEKO (COPACKAGED)
SYMDEKO (COPACKAGED) is protected by thirty-eight US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYMDEKO (COPACKAGED) is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SYMDEKO (COPACKAGED)
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR F508DEL AND A SECOND CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 10058546
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
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)cyclopropanecarboxa- mide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
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)cyclopropanecarboxa- mide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
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)cyclopropanecarboxa- mide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
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)cyclopropanecarboxa- mide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
Pharmaceutical composition and administrations thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11564916 CLAIM 1
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CF IN A PATIENT AGE 6 YEARS AND OLDER WHO IS HOMOZYGOUS FOR F508DEL OR HAS AT LEAST ONE CFTR GENE MUTATION RESPONSIVE TO TEZ/IVA BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE USING THE COMPOSITION RECITED IN US 11578062 CLAIM 6 OR 13
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 YEARS AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH AN EFFECTIVE AMOUNT OF TEZACAFTOR AND IVACAFTOR
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 11951212
Modulators of ATP-binding cassette transporters
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Patent Expiration: ⤷ Sign Up
Indole derivatives as CFTR modulators
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Modulators of ATP-binding cassette transporters
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Modulators of ATP-binding cassette transporters
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Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF PATIENTS WITH A MILD TO MODERATE CLINICAL PHENOTYPE OF CYSTIC FIBROSIS HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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)cyclopropanecarbox- amide and administration thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HETEROZYGOUS FOR THE F508DEL MUTATION AND A SECOND MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVING AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE
Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CYSTIC FIBROSIS PATIENTS AGES 6 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (
Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-- 3-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CYSTIC FIBROSIS PATIENTS AGES 12 AND OLDER, WHO ARE HOMOZYGOUS FOR F508DEL OR HAVE AT LEAST 1 CFTR GENE MUTATION RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND A SOLID COMPOSITION COMPRISING AMORPHOUS (
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 6 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
Modulators of ATP-binding cassette transporters
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 AND OLDER, WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR HAVE AT LEAST ONE CFTR GENE MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH TEZACAFTOR AND IVACAFTOR
FDA Regulatory Exclusivity protecting SYMDEKO (COPACKAGED)
TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR
Exclusivity Expiration: ⤷ Sign Up
FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET;ORAL | 210491-001 | Feb 12, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Vertex Pharms Inc | SYMDEKO (COPACKAGED) | ivacaftor; ivacaftor, tezacaftor | TABLET;ORAL | 210491-002 | Jun 21, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SYMDEKO (COPACKAGED)
When does loss-of-exclusivity occur for SYMDEKO (COPACKAGED)?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 15247850
Patent: Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Estimated Expiration: ⤷ Sign Up
Patent: 19250116
Patent: Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016023422
Patent: Dispersão seca por spray, composição farmacêutica e seus usos, kit e comprimido
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 44140
Patent: COMPOSITIONS PHARMACEUTIQUES DESTINEES AU TRAITEMENT DES MALADIES LIEES AU REGULATEUR DE LA CONDUCTANCE TRANSMEMBRANAIRE DE LA MUCOVISCIDOSE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 16002600
Patent: Composiciones farmacéuticas para el tratamiento de enfermedades mediadas por el regulador de conductancia transmenbrana de la fibrosis quística
Estimated Expiration: ⤷ Sign Up
Patent: 20002757
Patent: Composiciones farmacéuticas para el tratamiento de enfermedades mediadas por el regulador de conductancia transmenbrana de la fibrosis quística (divisional solicitud no. 2600-2016)
Estimated Expiration: ⤷ Sign Up
China
Patent: 6163517
Patent: 用于治疗囊性纤维化跨膜传导调节因子介导的疾病的药物组合物 (Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases)
Estimated Expiration: ⤷ Sign Up
Patent: 0840847
Patent: 用于治疗囊性纤维化跨膜传导调节因子介导的疾病的药物组合物 (Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases)
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181194
Estimated Expiration: ⤷ Sign Up
Patent: 0211012
Estimated Expiration: ⤷ Sign Up
Patent: 0230709
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20582
Estimated Expiration: ⤷ Sign Up
Patent: 24568
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 31582
Estimated Expiration: ⤷ Sign Up
Patent: 24534
Estimated Expiration: ⤷ Sign Up
Patent: 25607
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 31582
Patent: COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT DES MALADIES LIÉES AU RÉGULATEUR DE LA CONDUCTANCE TRANSMEMBRANAIRE DE LA MUCOVISCIDOSE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
Estimated Expiration: ⤷ Sign Up
Patent: 24534
Patent: COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT DES MALADIES LIÉES AU RÉGULATEUR DE LA CONDUCTANCE TRANSMEMBRANAIRE DE LA MUCOVISCIDOSE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
Estimated Expiration: ⤷ Sign Up
Patent: 25607
Patent: COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT DES MALADIES LIÉES AU RÉGULATEUR DE LA CONDUCTANCE TRANSMEMBRANAIRE DE LA MUCOVISCIDOSE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
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Patent: 23294
Patent: COMPOSITIONS PHARMACEUTIQUES POUR LE TRAITEMENT DE MALADIES INDUITES PAR LE RÉGULATEUR DE CONDUCTANCE TRANSMEMBRANAIRE DE LA FIBROSE KYSTIQUE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 25607
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 39062
Estimated Expiration: ⤷ Sign Up
Patent: 55369
Estimated Expiration: ⤷ Sign Up
Patent: 62736
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 8359
Patent: תכשירי רוקחות לטיפול במחלות קשורות למאפנני הרגולטור למוליכות הטרנסממברני של סיסטיק פיברוזה (Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases)
Estimated Expiration: ⤷ Sign Up
Patent: 6286
Patent: תכשירי רוקחות לטיפול במחלות קשורות למאפנני הרגולטור למוליכות הטרנסממברני של סיסטיק פיברוזה (Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases)
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Patent: 3422
Patent: תכשירי רוקחות לטיפול במחלות קשורות למאפנני הרגולטור למוליכות הטרנסממברני של סיסטיק פיברוזה (Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 43268
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Patent: 17511344
Patent: 嚢胞性線維症膜コンダクタンス調節因子が媒介する疾患を処置するための医薬組成物
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Mexico
Patent: 16013301
Patent: COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE ENFERMEDADES MEDIADAS POR EL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUISTICA. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES.)
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Patent: 21013638
Patent: COMPOSICIONES FARMACEUTICAS PARA EL TRATAMIENTO DE ENFERMEDADES MEDIADAS POR EL REGULADOR DE CONDUCTANCIA DE TRANSMEMBRANA DE FIBROSIS QUISTICA. (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES.)
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Morocco
Patent: 004
Patent: Compositions pharmaceutiques destinées au traitement des maladies liées au régulateur de la conductance transmembranaire de la mucoviscidose
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Patent: 476
Patent: COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT DES MALADIES LIÉES AU RÉGULATEUR DE LA CONDUCTANCE TRANSMEMBRANAIRE DE LA MUCOVISCIDOSE
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Patent: 774
Patent: COMPOSITIONS PHARMACEUTIQUES DESTINÉES AU TRAITEMENT DES MALADIES LIÉES AU RÉGULATEUR DE LA CONDUCTANCE TRANSMEMBRANAIRE DE LA MUCOVISCIDOSE
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New Zealand
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Patent: Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases
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Poland
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Portugal
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Patent: 24534
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Patent: 25607
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Russian Federation
Patent: 44460
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ОПОСРЕДОВАННЫХ МУКОВИСЦИДОЗНЫМ ТРАНСМЕМБРАННЫМ РЕГУЛЯТОРОМ ПРОВОДИМОСТИ (PHARMACEUTICAL COMPOSITIONS FOR TREATING DISEASES MEDIATED BY CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR)
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Patent: 16144479
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ОПОСРЕДОПОСРЕДОВАННЫХ МУКОВИСЦИДОЗНЫМ ТРАНСМЕМБРАННЫМ РЕГУЛЯТОРОМ ПРОВОДИМОСТИ
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Serbia
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Patent: FARMACEUTSKE KOMPOZICIJE ZA LEČENJE BOLESTI POSREDOVANIH TRANSMEMBRANSKIM REGULATOROM PROVODLJIVOSTI CISTIČNE FIBROZE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
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Patent: 140
Patent: FARMACEUTSKE KOMPOZICIJE ZA LEČENJE BOLESTI POSREDOVANIH TRANSMEMBRANSKIM REGULATOROM PROVODLJIVOSTI CISTIČNE FIBROZE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
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Patent: 400
Patent: FARMACEUTSKE KOMPOZICIJE ZA LEČENJE BOLESTI POSREDOVANIH TRANSMEMBRANSKIM REGULATOROM PROVODLJIVOSTI CISTIČNE FIBROZE (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
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Singapore
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Slovenia
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South Africa
Patent: 1606418
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South Korea
Patent: 2447581
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Patent: 160145124
Patent: 낭포성 섬유증 막전도 조절자 매개 질환 치료용 약제학적 조성물 (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
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Spain
Patent: 75858
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Patent: 85181
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Patent: 57761
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Turkey
Patent: 1809684
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Ukraine
Patent: 4567
Patent: ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ ДЛЯ ЛІКУВАННЯ ЗАХВОРЮВАНЬ, ОПОСЕРЕДКОВАНИХ МУКОВІСЦИДОЗНИМ РЕГУЛЯТОРОМ ТРАНСМЕМБРАННОЇ ПРОВІДНОСТІ (PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR MEDIATED DISEASES)
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering SYMDEKO (COPACKAGED) around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2015127334 | （Ｒ）−１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソール−５−イル）−Ｎ−（１−（２，３−ジヒドロキシプロピル）−６−フルオロ−２−（１−ヒドロキシ−２−メチルプロパン−２−イル）−１Ｈ−インドール−５−イル）シクロプロパンカルボキサミドの固体形態 (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) | ⤷ Sign Up |
| European Patent Office | 2502914 | Modulateurs de transporteurs de cassette de liaison à l ́ATP (Modulators of ATP-binding cassette transporters) | ⤷ Sign Up |
| Russian Federation | 2009142030 | МОДУЛЯТОРЫ ТРАНСПОРТЕРОВ АТФ-СВЯЗЫВАЮЩЕЙ КАССЕТЫ | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYMDEKO (COPACKAGED)
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1773816 | CA 2015 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: IVACAFTOR, N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLIN-3-CARBOXAMID ELLER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/12/782/001-002 20120723 |
| 2826776 | PA2021508,C2826776 | Lithuania | ⤷ Sign Up | PRODUCT NAME: (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOKSOL-5-IL)-N-(1-(2,3-DIHIDROKSIPROPIL)-6-FLUOR-2-(1-HIDROKSI-2-METILPROPAN-2-IL)-1H-INDOL-5-IL) CIKLOPROPANKARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS IR (B) N-(5-HIDROKSI-2,4-DITERT-BUTIL-FENIL)-4-OKSO-1H-CHINOLIN-3-KARBOKSAMIDO ARBA FARMACISKAI PRIIMTINOS JO DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/18/1306 20181031 |
| 2826776 | CR 2021 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: EN KOMBINATION AF (A) (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)CYCLOPROPANECARBOXAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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