Last Updated: May 11, 2026

VIEKIRA PAK (COPACKAGED) Drug Patent Profile


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When do Viekira Pak (copackaged) patents expire, and when can generic versions of Viekira Pak (copackaged) launch?

Viekira Pak (copackaged) is a drug marketed by Abbvie and is included in one NDA. There are fifteen patents protecting this drug.

This drug has five hundred and sixty-five patent family members in fifty-two countries.

The generic ingredient in VIEKIRA PAK (COPACKAGED) is dasabuvir sodium; ombitasvir, paritaprevir, ritonavir. Additional details are available on the dasabuvir sodium; ombitasvir, paritaprevir, ritonavir profile page.

DrugPatentWatch® Generic Entry Outlook for Viekira Pak (copackaged)

Viekira Pak (copackaged) was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 13, 2032. This may change due to patent challenges or generic licensing.

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIEKIRA PAK (COPACKAGED)
Generic Entry Date for VIEKIRA PAK (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;ORAL

*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 VIEKIRA PAK (COPACKAGED)

VIEKIRA PAK (COPACKAGED) is protected by fifteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIEKIRA PAK (COPACKAGED) is ⤷  Start Trial.

This potential generic entry date is based on patent ⤷  Start Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir, paritaprevir, ritonavir TABLET;ORAL 206619-001 Dec 19, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir, paritaprevir, ritonavir TABLET;ORAL 206619-001 Dec 19, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbvie VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir, paritaprevir, ritonavir TABLET;ORAL 206619-001 Dec 19, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Abbvie VIEKIRA PAK (COPACKAGED) dasabuvir sodium; ombitasvir, paritaprevir, ritonavir TABLET;ORAL 206619-001 Dec 19, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VIEKIRA PAK (COPACKAGED)

International Patents for VIEKIRA PAK (COPACKAGED)

When does loss-of-exclusivity occur for VIEKIRA PAK (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7060
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 3240
Patent: COMPOSICIONES SOLIDAS PARA TRATAMIENTO DE INFECCIONES DEL HCV (HEPATITIS C)
Estimated Expiration: ⤷  Start Trial

Patent: 3398
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 2505
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 4816
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Australia

Patent: 10258769
Patent: Anti-viral compounds to treat HCV infection
Estimated Expiration: ⤷  Start Trial

Patent: 11264823
Patent: Solid compositions
Estimated Expiration: ⤷  Start Trial

Patent: 11316506
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Brazil

Patent: 2012031500
Estimated Expiration: ⤷  Start Trial

Patent: 2013005701
Patent: compostos antivirais
Estimated Expiration: ⤷  Start Trial

Patent: 2012031500
Estimated Expiration: ⤷  Start Trial

Patent: 1004894
Patent: compostos antivirais
Estimated Expiration: ⤷  Start Trial

Canada

Patent: 37601
Patent: COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 02180
Patent: COMPOSITIONS SOLIDES (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 07847
Patent: COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 19894
Patent: COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 28495
Patent: COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 47910
Patent: COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 38547
Patent: COMPOSES ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 97170
Patent: DERIVES ANTI-VIRAUX DE TETRAHYDROFURANE (ANTI-VIRAL TETRAHYDROFURANE DERIVATIVES)
Estimated Expiration: ⤷  Start Trial

Chile

Patent: 11000689
Patent: Compuesto derivado de ((4-terbutilfenil)pirrolidin-2,5-diil)bis(4,1-fenilen)sustituido, inhibidor de la replicacion del vhc; composicion farmaceutica; util en el tratamiento de una infeccion por vhc.
Estimated Expiration: ⤷  Start Trial

Patent: 12003470
Patent: Una composicion solida que comprende 1) un compuesto inhibidor del hcv de formula definida, o una sal farmaceuticamente aceptable de este, en una forma amorfa, 2) un polimero hidrofilico, y opcionalmente 3) un agente tensoactivo; su proceso de preparacion, util para tratar una infeccion del hcv.
Estimated Expiration: ⤷  Start Trial

Patent: 13000970
Patent: Compuestos derivados de heterociclos nitrogenados sustituidos; sus composiciones farmaceuticas, y uso como inhiibidores de la replicacion del hcv para el tratamiento de la hepatitis c.
Estimated Expiration: ⤷  Start Trial

Patent: 13002299
Patent: Compuestos derivados de heterociclos, inhibidores de la replicacion del virus de la hepatitis c; composicion farmaceutica que los comprende; util en el tratamiento de una infeccion por vhc. (divisional solicitud 689-2011).
Estimated Expiration: ⤷  Start Trial

Patent: 14000059
Patent: Compuestos derivados de heterociclos nitrogenados sustituidos; proceso de preparacion; compuesto intermediario; composiciones farmaceuticas; utiles como inhiibidores de la replicacion del hcv para tratar la hepatitis c. (div. sol. 970-13)
Estimated Expiration: ⤷  Start Trial

China

Patent: 2333772
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 3153988
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 3172620
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 3209686
Patent: Solid compositions
Estimated Expiration: ⤷  Start Trial

Patent: 3354808
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 3596941
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 3819459
Patent: Anti-Viral Compounds
Estimated Expiration: ⤷  Start Trial

Patent: 3819537
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 4193729
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 6986861
Patent: 抗病毒化合物 (Anti-viral compounds)
Estimated Expiration: ⤷  Start Trial

Patent: 8350016
Patent: 抗病毒四氢呋喃衍生物 (Anti-viral tetrahydrofurane derivatives)
Estimated Expiration: ⤷  Start Trial

Colombia

Patent: 40538
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 60490
Patent: Composiciones solidas
Estimated Expiration: ⤷  Start Trial

Patent: 61348
Patent: Compuestos antivirales
Estimated Expiration: ⤷  Start Trial

Costa Rica

Patent: 120650
Patent: COMPOSICIONES SÓLIDAS
Estimated Expiration: ⤷  Start Trial

Patent: 130170
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 140021
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Croatia

Patent: 0130671
Estimated Expiration: ⤷  Start Trial

Patent: 0150017
Estimated Expiration: ⤷  Start Trial

Patent: 0150926
Estimated Expiration: ⤷  Start Trial

Patent: 0151389
Estimated Expiration: ⤷  Start Trial

Patent: 0160408
Estimated Expiration: ⤷  Start Trial

Patent: 0181658
Estimated Expiration: ⤷  Start Trial

Cyprus

Patent: 14356
Estimated Expiration: ⤷  Start Trial

Patent: 16060
Estimated Expiration: ⤷  Start Trial

Patent: 16748
Estimated Expiration: ⤷  Start Trial

Patent: 17188
Estimated Expiration: ⤷  Start Trial

Patent: 17456
Estimated Expiration: ⤷  Start Trial

Patent: 22267
Estimated Expiration: ⤷  Start Trial

Patent: 15012
Estimated Expiration: ⤷  Start Trial

Patent: 17031
Estimated Expiration: ⤷  Start Trial

Denmark

Patent: 68890
Estimated Expiration: ⤷  Start Trial

Patent: 55376
Estimated Expiration: ⤷  Start Trial

Patent: 79854
Estimated Expiration: ⤷  Start Trial

Patent: 28481
Estimated Expiration: ⤷  Start Trial

Patent: 92346
Estimated Expiration: ⤷  Start Trial

Patent: 54892
Estimated Expiration: ⤷  Start Trial

Dominican Republic

Patent: 011000087
Patent: Compuestos eficaces para inhibir la replicación del virus de la hepatitis c("HCV")
Estimated Expiration: ⤷  Start Trial

Patent: 012000307
Patent: COMPOSICIONES SOLIDAS
Estimated Expiration: ⤷  Start Trial

Patent: 013000078
Patent: COMPUESTO DERIVADO DE HETEROCICLOS NITROGENADOS SUSTITUIDOS, EFICAZ COMO INHIBIDOR DE LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C, COMPOSICIÓN QUE LO COMPRENDE Y SU USO
Estimated Expiration: ⤷  Start Trial

Patent: 013000185
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Ecuador

Patent: 11010937
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 13010937
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 13012382
Patent: COMPOSICIONES SÓLIDAS
Estimated Expiration: ⤷  Start Trial

Patent: 13012622
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 14012622
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 17064986
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Eurasian Patent Organization

Patent: 0031
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 3570
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 4100
Patent: МЕТИЛ {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-ДИФТОР-4-[4-(4-ФТОРФЕНИЛ)ПИПЕРИДИН-1-ИЛ]ФЕНИЛ}-5-(6-ФТОР-2-{(2S)-1-[N-(МЕТОКСИКАРБОНИЛ)-О-МЕТИЛ-L-ТРЕОНИЛ]ПИРРОЛИДИН-2-ИЛ}-1H-БЕНЗИМИДАЗОЛ-5-ИЛ)ПИРРОЛИДИН-2-ИЛ]-6-ФТОР-1H-БЕНЗИМИДАЗОЛ-2-ИЛ}ПИРРОЛИДИН-2-ИЛ]-3-МЕТОКСИ-1-ОКСОБУТАН-2-ИЛ}КАРБАМАТ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ЕГО, И СПОСОБ ЛЕЧЕНИЯ ИНФЕКЦИИ ГЕПАТИТА C (METHYL {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-DIFLUORO-4-[4-(4-FLUOROPHENYL)PIPERIDIN-1-YL]PHENYL}-5-(6-FLUORO-2-{(2S)-1-[N-(METHOXYCARBONYL)-O-METHYL-L-THREONYL]PYRROLIDIN-2-yl}-1H-BENZIMIDAZOL-5-YL)PYRROLIDIN-2-YL]-6-FLUORO-1H-BENZIMIDAZOL-2-YL}PYRROLIDIN-1-YL]-3-METHOXY-1-OXOBUTAN-2-YL}CARBAMATE, PHARMACEUTICAL COMPOSITION COMPRISING SAME, AND METHOD OF TREATING HCV INFECTION)
Estimated Expiration: ⤷  Start Trial

Patent: 4538
Patent: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ СОЕДИНЕНИЕ С АНТИ-ВГС (HCV) АКТИВНОСТЬЮ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A COMPOUND WITH ANTI-HCV ACTIVITY)
Estimated Expiration: ⤷  Start Trial

Patent: 6848
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ (ANTIVIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 3332
Patent: СПОСОБ ПОЛУЧЕНИЯ МЕТИЛ {(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-ДИФТОР-4-[4-(4-ФТОРФЕНИЛ)ПИПЕРИДИН-1-ИЛ]ФЕНИЛ}-5-(6-ФТОР-2-{(2S)-1-[N-(МЕТОКСИКАРБОНИЛ)-О-МЕТИЛ-L-ТРЕОНИЛ]ПИРРОЛИДИН-2-ИЛ}-1Н-БЕНЗИМИДАЗОЛ-5-ИЛ)ПИРРОЛИДИН-2-ИЛ]-6-ФТОР-1Н-БЕНЗИМИДАЗОЛ-2-ИЛ}ПИРРОЛИДИН-1-ИЛ]-3-МЕТОКСИ-1-ОКСОБУТАН-2-ИЛ} КАРБАМАТА (PROCESS FOR PREPARING METHYL{(2S,3R)-1-[(2S)-2-{5-[(2R,5R)-1-{3,5-DIFLUORO-4-[4-(4-FLUOROPHENYL)PIPERIDINE-1-YL]PHENYL}-5-(6-FLUORO-2-{(2S)-1-[N-(METHOXYCARBONYL)-O-METHYL-L-THREONYL]PYRROLIDINE-2-YL}-1H-BENZIMIDAZOLE-5-YL)pyrrolidinePYRROLIDINE-2-YL]-6-FLUORO-1H-BENZIMIDAZOLE-2-YL}PYRROLIDINE-1-YL]-3-METHOXY-1-OXOBUTANE-2-YL}CARBAMATE)
Estimated Expiration: ⤷  Start Trial

Patent: 1170401
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Start Trial

Patent: 1291394
Patent: ТВЕРДЫЕ КОМПОЗИЦИИ
Estimated Expiration: ⤷  Start Trial

Patent: 1300495
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Start Trial

Patent: 1301158
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Start Trial

Patent: 1390538
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Start Trial

Patent: 1400115
Patent: ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Start Trial

European Patent Office

Patent: 37781
Patent: COMPOSÉS ANTIVIRAUX POUR LE TRAITEMENT D'INFECTIONS HCV (ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION)
Estimated Expiration: ⤷  Start Trial

Patent: 68890
Patent: Inhibiteurs de la hépatite C (Hepatitis C virus inhibitors)
Estimated Expiration: ⤷  Start Trial

Patent: 55376
Patent: Composés hétérocycliques comme inhibiteurs du virus de'l hepatite C (HCV) (Heterocyclic compounds as inhibitors of hepatitis C virus (HCV))
Estimated Expiration: ⤷  Start Trial

Patent: 79854
Patent: COMPOSITIONS SOLIDES (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 27651
Patent: COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 28481
Patent: Dérivés hétérocycliques trisubstitués comme inhibiteurs de la réplication du virus de l'hépatite C HCV (Trisubstituted heterocycles as replication inhibitors of hepatitis C virus HCV)
Estimated Expiration: ⤷  Start Trial

Patent: 51885
Patent: COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 78334
Patent: COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 92346
Patent: Dérivé antiviraux de 2,5-dibenzimidazol-5-yl-1-phényl-pyrrolidine (An antiviral 1-phenyl-2,5-dibenzimidazol-5-yl-pyrrolidine derivative)
Estimated Expiration: ⤷  Start Trial

Patent: 92726
Patent: Composés antiviraux (Anti-viral compounds)
Estimated Expiration: ⤷  Start Trial

Patent: 53531
Patent: Composés antiviraux (Antiviral compounds)
Estimated Expiration: ⤷  Start Trial

Patent: 54892
Patent: COMPOSITIONS SOLIDES (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 44642
Patent: DÉRIVÉS ANTI-VIRAUX DE TÉTRAHYDROFURANE (ANTI-VIRAL TETRAHYDROFURANE DERIVATIVES)
Estimated Expiration: ⤷  Start Trial

Patent: 38106
Patent: COMPOSÉS ANTIVIRAUX (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 56318
Patent: COMPOSITIONS SOLIDES (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

France

Patent: C1040
Estimated Expiration: ⤷  Start Trial

Guatemala

Patent: 1100074
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 1200332
Patent: COMPOSICIONES SÒLIDAS
Estimated Expiration: ⤷  Start Trial

Patent: 1300093
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 1300093A
Patent: COMPUESTOS ANTIVIRALES (SOLICITUD DIVISIONAL FRACCIONARIA DE LA SOLICITUD A-2013-00093)
Estimated Expiration: ⤷  Start Trial

Hong Kong

Patent: 52620
Patent: 治療 感染的抗病毒化合物 (ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION HCV)
Estimated Expiration: ⤷  Start Trial

Patent: 61245
Patent: HEPATITIS C VIRUS INHIBITORS
Estimated Expiration: ⤷  Start Trial

Patent: 70739
Patent: 作為丙型肝炎病毒 抑制劑的雜環化合物 (HETEROCYCLIC COMPOUNDS AS INHIBITORS OF HEPATITIS C VIRUS (HCV) (HCV))
Estimated Expiration: ⤷  Start Trial

Patent: 84068
Patent: 固體組合物 (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 86415
Patent: 作為丙型肝炎病毒 的複製抑制劑的三取代雜環 (TRISUBSTITUTED HETEROCYCLES AS REPLICATION INHIBITORS OF HEPATITIS C VIRUS HCV HCV)
Estimated Expiration: ⤷  Start Trial

Patent: 88717
Patent: 種抗病毒 -苯基- -二苯並咪唑- -基-吡咯烷衍生物 (AN ANTIVIRAL 1-PHENYL-2,5-DIBENZIMIDAZOL-5-YL-PYRROLIDINE DERIVATIVE 1--25--5--)
Estimated Expiration: ⤷  Start Trial

Hungary

Patent: 25758
Estimated Expiration: ⤷  Start Trial

Patent: 26832
Estimated Expiration: ⤷  Start Trial

Patent: 28825
Estimated Expiration: ⤷  Start Trial

Patent: 39719
Estimated Expiration: ⤷  Start Trial

Patent: 500019
Estimated Expiration: ⤷  Start Trial

Patent: 700040
Estimated Expiration: ⤷  Start Trial

Israel

Patent: 1792
Patent: דימתיל (2s,2's)-1,'1-((2s,2's)-2,'2-(4,'4-((2s,5s)-1-(4-טרט-בוטילפניל)פירולידין-5,2-דיאיל)ביס(1,4 פנילן))ביס (אזאנדיאיל)ביס(אוקסומתילן)ביס(פירולידין-1,2-דיאיל))ביס(3- מתיל-1-אוקסובוטן-1,2-דיאיל)דיקארבמאט והרכב רוקחי המכיל אותו (Dimethyl (2s, 2's)-1, 1'-((2s,2's)-2,2'-(4,4' -((2s,5s)-1 -(4-tert-butylphenyl) pyrrolidine-2,5 -diyl) bis (4,1 phenylene)) bis (azanediyl) bis (oxomethylene) bis (pyrrolidine-2,1-diyl)) bis (3-methyl-1-oxobutane-2,1 -diyl) dicarbamate and a pharmaceutical composition comprising same)
Estimated Expiration: ⤷  Start Trial

Patent: 3535
Patent: הרכבים תרופתיים מוצקים (Solid pharmaceutical compositions)
Estimated Expiration: ⤷  Start Trial

Patent: 5010
Patent: מתיל (2s,3r)-1-((1s)-2-(-2-(-5-((2r,3r)-1-(3,5,דיפלואורו-4-(4-(4-פלואורופניל)פיפרידינ-1-איל(פניל)-5-(6-פלואורו-2-((2s)-1-(n-(מתוקסיקרבוניל)-o-מתיל-l-תראוניל)פירולידינ-1-איל)-1י-בנזואימידזול-5-איל)פירולידין-2-איל)-6-פלואורו-1h-בנזאימידזול-2-איל)פירולידינ-1-איל)-3-מתוקסי-1-אוקסובוטאנ-2-איל)קרבאמט והרכב רוקחי המכיל אותו (Methyl {(2s,3r)-1-[(2s)-2-{5-[(2r,5r)-1-{3,5-difluoro-4-[4-(4-fluorophenyl)piperidin-1-yl]phenyl}-5-(6-fluoro-2-{(2s)-1-[n-(methoxycarbonyl)-o-methyl-l-threonyl]pyrrolidin-2-yl}-1h-benzimidazol-5-yl)pyrrolidin-2-yl]-6-fluoro-1h-benzimidazol-2-yl}pyrrolidin-1-yl]-3-methoxy-1-oxobutan-5 2-yl}carbamate and a pharmaceutical composition comprising it)
Estimated Expiration: ⤷  Start Trial

Patent: 9248
Patent: תרכובות נגד נגיפים והרכבים רוקחיים המכילים אותן (Anti-viral compounds and pharmaceutical compositions comprising same)
Estimated Expiration: ⤷  Start Trial

Patent: 3857
Patent: תרכובות נגד נגיפים (Anti-viral compounds)
Estimated Expiration: ⤷  Start Trial

Patent: 4781
Patent: תרכובות נגד נגיפים (Anti-viral compounds)
Estimated Expiration: ⤷  Start Trial

Patent: 1206
Patent: תרכובות אנטי-וירליות (Anti-viral compounds)
Estimated Expiration: ⤷  Start Trial

Japan

Patent: 30514
Estimated Expiration: ⤷  Start Trial

Patent: 14356
Estimated Expiration: ⤷  Start Trial

Patent: 34085
Estimated Expiration: ⤷  Start Trial

Patent: 06253
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Patent: 11838
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Patent: 22699
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Patent: 59830
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Patent: 59736
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Patent: 86147
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Patent: 43135
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Patent: 90202
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Patent: 12529534
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Patent: 13528225
Estimated Expiration: ⤷  Start Trial

Patent: 13539791
Estimated Expiration: ⤷  Start Trial

Patent: 14065710
Patent: ANTI-VIRAL COMPOUNDS FOR TREATING HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 14144973
Patent: ANTI-VIRAL COMPOUND FOR TREATING HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 14504296
Estimated Expiration: ⤷  Start Trial

Patent: 14510063
Estimated Expiration: ⤷  Start Trial

Patent: 16106075
Patent: 抗ウィルス化合物 (ANTI-VIRUS COMPOUND)
Estimated Expiration: ⤷  Start Trial

Patent: 16128456
Patent: HCV感染を治療するための抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS FOR TREATING HCV INFECTION)
Estimated Expiration: ⤷  Start Trial

Patent: 17171680
Patent: HCV感染を治療するための抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION)
Estimated Expiration: ⤷  Start Trial

Patent: 18065828
Patent: 抗ウィルス化合物 (ANTI-VIRUS COMPOUND)
Estimated Expiration: ⤷  Start Trial

Patent: 18529671
Patent: 抗ウィルス性テトラヒドロフラン誘導体
Estimated Expiration: ⤷  Start Trial

Patent: 19194254
Patent: HCV感染を治療するための抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS FOR TREATING HCV INFECTION)
Estimated Expiration: ⤷  Start Trial

Patent: 20059696
Patent: 抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 21035964
Patent: 抗ウィルス化合物 (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Lithuania

Patent: 54892
Estimated Expiration: ⤷  Start Trial

Patent: 368890
Estimated Expiration: ⤷  Start Trial

Patent: 692346
Estimated Expiration: ⤷  Start Trial

Patent: 2017033
Estimated Expiration: ⤷  Start Trial

Luxembourg

Patent: 668
Estimated Expiration: ⤷  Start Trial

Patent: 0038
Estimated Expiration: ⤷  Start Trial

Malaysia

Patent: 4064
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 4607
Patent: SOLID COMPOSITIONS
Estimated Expiration: ⤷  Start Trial

Patent: 6633
Patent: HETEROCYCLIC COMPOUNDS AS INHIBITORS OF HEPATITIS C VIRUS (HCV)
Estimated Expiration: ⤷  Start Trial

Mexico

Patent: 9989
Patent: COMPUESTOS ANTI-VIRALES. (ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION.)
Estimated Expiration: ⤷  Start Trial

Patent: 4092
Patent: COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Start Trial

Patent: 6264
Patent: COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Start Trial

Patent: 11005673
Patent: COMPUESTOS ANTI-VIRALES PARA TRATAR INFECCION POR VHC. (ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION.)
Estimated Expiration: ⤷  Start Trial

Patent: 12014384
Patent: COMPOSICIONES SOLIDAS. (SOLID COMPOSITIONS.)
Estimated Expiration: ⤷  Start Trial

Patent: 13004150
Patent: CONPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Start Trial

Patent: 13006951
Patent: COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Start Trial

Patent: 13009763
Patent: COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Start Trial

Patent: 18002707
Patent: DERIVADOS DE TETRAHIDROFURANO ANTIVIRALES. (ANTI-VIRAL TETRAHYDROFURANE DERIVATIVES.)
Estimated Expiration: ⤷  Start Trial

Patent: 20002151
Patent: COMPUESTOS ANTIVIRALES. (ANTI-VIRAL COMPOUNDS.)
Estimated Expiration: ⤷  Start Trial

Montenegro

Patent: 201
Patent: PRIPRAVCI U KRUTOM STANJU (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 328
Patent: ANTIVIRUSNI 2, 5-DIBENZIMIDAZOL- 5- IL-1-FENIL- PIROLIDINDERIVAT (An antiviral 1- phenyl- 2,5-dibenzimidazol-5-yl-pyrrolidine derivative)
Estimated Expiration: ⤷  Start Trial

Netherlands

Patent: 0731
Estimated Expiration: ⤷  Start Trial

Patent: 0901
Estimated Expiration: ⤷  Start Trial

New Zealand

Patent: 1973
Patent: ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 5440
Patent: SOLID COMPOSITIONS COMPRISING AN HCV INHIBITOR
Estimated Expiration: ⤷  Start Trial

Patent: 6645
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 5562
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Norway

Patent: 15012
Estimated Expiration: ⤷  Start Trial

Patent: 17057
Estimated Expiration: ⤷  Start Trial

Patent: 21039
Estimated Expiration: ⤷  Start Trial

Peru

Patent: 110679
Patent: DERIVADOS DE (4-TERT-BUTILFENIL)PIRROLIDIN-2,5-DIFENIL COMO INHIBIDORES DEL HCV
Estimated Expiration: ⤷  Start Trial

Patent: 131036
Patent: COMPOSICIONES SOLIDAS QUE COMPRENDEN COMPUESTOS ANTI-HCV
Estimated Expiration: ⤷  Start Trial

Patent: 140038
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 140835
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 141083
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Philippines

Patent: 012502442
Estimated Expiration: ⤷  Start Trial

Patent: 013500708
Estimated Expiration: ⤷  Start Trial

Patent: 015500289
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Poland

Patent: 68890
Estimated Expiration: ⤷  Start Trial

Patent: 55376
Estimated Expiration: ⤷  Start Trial

Patent: 79854
Estimated Expiration: ⤷  Start Trial

Patent: 28481
Estimated Expiration: ⤷  Start Trial

Patent: 92346
Estimated Expiration: ⤷  Start Trial

Patent: 54892
Estimated Expiration: ⤷  Start Trial

Portugal

Patent: 68890
Estimated Expiration: ⤷  Start Trial

Patent: 55376
Estimated Expiration: ⤷  Start Trial

Patent: 79854
Estimated Expiration: ⤷  Start Trial

Patent: 92346
Estimated Expiration: ⤷  Start Trial

Patent: 54892
Estimated Expiration: ⤷  Start Trial

San Marino

Patent: 01500263
Patent: COMPOSIZIONI SOLIDE
Estimated Expiration: ⤷  Start Trial

Patent: 01800532
Estimated Expiration: ⤷  Start Trial

Serbia

Patent: 854
Patent: INHIBITORI HEPATITIS C VIRUSA (HEPATITIS C VIRUS INHIBITORS)
Estimated Expiration: ⤷  Start Trial

Patent: 856
Patent: HETEROCIKLIČNA JEDINJENJA KAO INHIBITORI HEPATITIS C VIRUSA (HETEROCYCLIC COMPOUNDS AS INHIBITORS OF HEPATITIS C VIRUS (HCV))
Estimated Expiration: ⤷  Start Trial

Patent: 282
Patent: ČVRSTE SMEŠE (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 619
Patent: ANTIVIRUSNI DERIVAT 1-FENIL-2,5-DIBENZIMIDAZOL-5-IL-PIROLIDINA (AN ANTIVIRAL 1-PHENYL-2,5-DIBENZIMIDAZOL-5-YL-PYRROLIDINE DERIVATIVE)
Estimated Expiration: ⤷  Start Trial

Patent: 790
Patent: TRISUPSTITUISANI HETEROCIKLI KAO INHIBITORI REPLIKACIJE VIRUSA HEPATITISA C HCV (TRISUBSTITUTED HETEROCYCLES AS REPLICATION INHIBITORS OF HEPATITIS C VIRUS HCV)
Estimated Expiration: ⤷  Start Trial

Patent: 982
Patent: ČVRSTI SASTAVI (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Singapore

Patent: 201702522U
Patent: ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 1708
Patent: ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 6251
Patent: SOLID COMPOSITIONS
Estimated Expiration: ⤷  Start Trial

Patent: 8951
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Slovenia

Patent: 68890
Estimated Expiration: ⤷  Start Trial

Patent: 55376
Estimated Expiration: ⤷  Start Trial

Patent: 79854
Estimated Expiration: ⤷  Start Trial

Patent: 28481
Estimated Expiration: ⤷  Start Trial

Patent: 92346
Estimated Expiration: ⤷  Start Trial

Patent: 54892
Estimated Expiration: ⤷  Start Trial

South Africa

Patent: 1102425
Patent: ANTI-VIRAL COMPOUNDS.
Estimated Expiration: ⤷  Start Trial

Patent: 1203502
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 1203503
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 1300112
Patent: SOLID COMPOSITIONS
Estimated Expiration: ⤷  Start Trial

Patent: 1302269
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 1705519
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 1903284
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

South Korea

Patent: 1452916
Estimated Expiration: ⤷  Start Trial

Patent: 1481395
Estimated Expiration: ⤷  Start Trial

Patent: 1586215
Estimated Expiration: ⤷  Start Trial

Patent: 1677481
Estimated Expiration: ⤷  Start Trial

Patent: 1831154
Estimated Expiration: ⤷  Start Trial

Patent: 1990936
Estimated Expiration: ⤷  Start Trial

Patent: 2059386
Estimated Expiration: ⤷  Start Trial

Patent: 120117620
Patent: ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 130053440
Patent: 고체 조성물 (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 140032338
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 140037974
Patent: ANTI-VIRAL COMPOUNDS TO TREAT HCV INFECTION
Estimated Expiration: ⤷  Start Trial

Patent: 140143152
Patent: ANTI-VIRAL COMPOUNDS
Estimated Expiration: ⤷  Start Trial

Patent: 150008151
Patent: SOLID COMPOSITIONS
Estimated Expiration: ⤷  Start Trial

Patent: 180023014
Patent: 고체 조성물 (SOLID COMPOSITIONS)
Estimated Expiration: ⤷  Start Trial

Patent: 180026775
Patent: 항바이러스 화합물 (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Spain

Patent: 14934
Estimated Expiration: ⤷  Start Trial

Patent: 11440
Estimated Expiration: ⤷  Start Trial

Patent: 26908
Estimated Expiration: ⤷  Start Trial

Patent: 46767
Estimated Expiration: ⤷  Start Trial

Patent: 60842
Estimated Expiration: ⤷  Start Trial

Patent: 65536
Estimated Expiration: ⤷  Start Trial

Patent: 24246
Estimated Expiration: ⤷  Start Trial

Patent: 91625
Estimated Expiration: ⤷  Start Trial

Taiwan

Patent: 1102063
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 1204713
Patent: Solid compositions
Estimated Expiration: ⤷  Start Trial

Patent: 1238948
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 1247648
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 1334778
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 1347759
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 1412707
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 1519891
Patent: Anti-viral compounds
Estimated Expiration: ⤷  Start Trial

Patent: 02070
Estimated Expiration: ⤷  Start Trial

Patent: 19874
Estimated Expiration: ⤷  Start Trial

Patent: 69780
Estimated Expiration: ⤷  Start Trial

Patent: 86159
Estimated Expiration: ⤷  Start Trial

Patent: 87700
Estimated Expiration: ⤷  Start Trial

Patent: 86660
Estimated Expiration: ⤷  Start Trial

Patent: 21611
Estimated Expiration: ⤷  Start Trial

Turkey

Patent: 1815161
Estimated Expiration: ⤷  Start Trial

Ukraine

Patent: 3052
Patent: ПРОТИВІРУСНІ СПОЛУКИ[ПРОТИВОВИРУСНЫЕ СОЕДИНЕНИЯ (ANTI-VIRAL COMPOUNDS)
Estimated Expiration: ⤷  Start Trial

Patent: 5434
Patent: ТВЕРДАЯ КОМПОЗИЦИЯ И СПОСОБ ЛЕЧЕНИЯ ГЕПАТИТА С;ТВЕРДА КОМПОЗИЦІЯ ТА СПОСІБ ЛІКУВАННЯ ВІРУСУ ГЕПАТИТУ С (SOLID COMPOSITION AND METHOD FOR TREATMENT OF HEPATITIS C)
Estimated Expiration: ⤷  Start Trial

Patent: 8904
Patent: ПРОТИВІРУСНІ СПОЛУКИ
Estimated Expiration: ⤷  Start Trial

Patent: 3048
Patent: ПРОТИВІРУСНІ СПОЛУКИ
Estimated Expiration: ⤷  Start Trial

Patent: 8080
Patent: ПРОТИВІРУСНІ СПОЛУКИ
Estimated Expiration: ⤷  Start Trial

Uruguay

Patent: 699
Patent: COMPUESTOS ANTIVIRALES EFICACES PARA INHIBIR LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C ("HCV"), PROCESOS, COMPOSICIONES, Y MÉTODOS RELACIONADOS
Estimated Expiration: ⤷  Start Trial

Patent: 446
Patent: COMPOSICIONES SOLIDAS
Estimated Expiration: ⤷  Start Trial

Patent: 667
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

Patent: 983
Patent: COMPUESTOS ANTIVIRALES EFICACES PARA INHIBIR LA REPLICACIÓN DEL VIRUS DE LA HEPATITIS C ("HCV") Y C OMPOSICIONES RELACIONADAS
Estimated Expiration: ⤷  Start Trial

Patent: 266
Patent: COMPUESTOS ANTIVIRALES
Estimated Expiration: ⤷  Start Trial

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 VIEKIRA PAK (COPACKAGED) around the world.

Country Patent Number Title Estimated Expiration
Poland 2368882 ⤷  Start Trial
Denmark 2468286 ⤷  Start Trial
European Patent Office 2130534 ⤷  Start Trial
Lithuania 2805726 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIEKIRA PAK (COPACKAGED)

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2692346 1790050-7 Sweden ⤷  Start Trial PRODUCT NAME: PIBRENTASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/17/1213 20170728
2368890 300731 Netherlands ⤷  Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2692346 122017000074 Germany ⤷  Start Trial PRODUCT NAME: PIBRENTASVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1213 20170726
2203431 CA 2015 00014 Denmark ⤷  Start Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

VIEKIRA PAK (COPACKAGED) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is VIEKIRA PAK's Place in the Hepatitis C Market?

VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir, and dasabuvir) is a regimen for the treatment of chronic hepatitis C virus (HCV) infection. It was developed by AbbVie and received U.S. Food and Drug Administration (FDA) approval in December 2014. VIEKIRA PAK represents a significant entry into the then-emerging market of direct-acting antiviral (DAA) therapies for HCV, a class of drugs that revolutionized treatment by offering higher cure rates and shorter treatment durations compared to older interferon-based regimens.

The drug is indicated for adult patients with genotype 1 (GT1) chronic HCV infection, specifically including those with cirrhosis. VIEKIRA PAK's development and market entry coincided with a period of intense competition and rapid innovation in the HCV therapeutic landscape. Other major players, including Gilead Sciences with its Harvoni and Sovaldi, and Merck & Co. with its Zepatier, also launched or were developing similar DAA regimens. This competitive environment significantly influenced pricing strategies, market access, and the overall financial trajectory of drugs like VIEKIRA PAK.

The introduction of VIEKIRA PAK was positioned as a pan-genotypic, interferon-free option for a specific genotype. Its packaging and dosing regimen were designed for ease of use, aiming to improve patient adherence. The regimen's efficacy was demonstrated in clinical trials, showing high sustained virologic response (SVR) rates, the primary endpoint for HCV cure.

Key characteristics of VIEKIRA PAK:

  • Active Ingredients: Ombitasvir, paritaprevir, ritonavir, dasabuvir
  • Indication: Treatment of chronic hepatitis C virus genotype 1 infection in adults.
  • Development: AbbVie Inc.
  • FDA Approval Date: December 2014
  • Mechanism of Action: Targets multiple stages of the HCV replication cycle, including NS3/4A protease, NS5A protein, and NS5B polymerase.

The initial market reception for VIEKIRA PAK was shaped by its novel mechanism of action and the significant unmet need for effective, tolerable HCV treatments. However, the competitive intensity and rapid obsolescence of earlier DAA generations presented considerable challenges.

What Has Been VIEKIRA PAK's Financial Performance?

AbbVie's financial reporting provides insight into VIEKIRA PAK's commercial performance. Following its launch, the drug initially contributed to AbbVie's revenue growth in the HCV segment. However, the highly competitive nature of the HCV market, coupled with the development of newer, broader-spectrum DAAs and the eventual decline in the overall patient pool seeking treatment for chronic HCV, led to a significant decrease in VIEKIRA PAK's sales over time.

AbbVie reported substantial sales for its HCV products in the initial years post-launch. For instance, in 2015, AbbVie's HCV product sales reached $3.2 billion, with VIEKIRA PAK being a primary contributor. By 2016, these sales further increased to $4.7 billion. However, the market dynamics shifted rapidly. Competition from Gilead's Harvoni, which offered a pan-genotypic solution with high cure rates for multiple genotypes, exerted significant pressure.

HCV Product Sales for AbbVie (in billions USD):

Year Total HCV Sales
2015 3.2
2016 4.7
2017 2.7
2018 1.4
2019 0.7
2020 0.2

Source: AbbVie Inc. Annual Reports [1, 2, 3, 4, 5, 6]

The decline from 2016 onwards reflects several factors:

  • Increased Competition: The market became saturated with highly effective DAA regimens that often covered a wider range of HCV genotypes.
  • Market Saturation: A substantial portion of the prevalent HCV patient population requiring treatment was addressed by earlier DAA launches.
  • Pricing Pressures: Intense competition led to significant price negotiations with payers and pharmacy benefit managers (PBMs), impacting gross revenue and net sales.
  • Pipeline Evolution: AbbVie itself introduced newer HCV therapies like Mavyret (glecaprevir/pibrentasvir) in 2017, which offered broader genotype coverage and a shorter treatment duration, effectively cannibalizing sales of VIEKIRA PAK. Mavyret became AbbVie's flagship HCV product.

By 2020, AbbVie's HCV franchise sales had significantly diminished, with VIEKIRA PAK and its related products no longer representing a substantial revenue stream for the company. The drug's financial trajectory demonstrates a common pattern in the pharmaceutical industry where innovation, competition, and market evolution can lead to rapid ascents followed by sharp declines in sales for specific therapeutic agents.

What are the Key Patent Expirations and Market Exclusivity Considerations?

The patent landscape and market exclusivity periods for VIEKIRA PAK are critical for understanding its long-term commercial viability and the potential for generic competition. AbbVie's intellectual property portfolio for VIEKIRA PAK encompassed patents covering the active pharmaceutical ingredients (APIs), formulations, methods of use, and manufacturing processes.

Key Patents and Exclusivity:

  • Composition of Matter Patents: These patents typically provide the longest period of exclusivity and cover the chemical structure of the active ingredients. For VIEKIRA PAK's components (ombitasvir, paritaprevir, ritonavir, dasabuvir), these patents would have been filed around the time of discovery and development. Given the 2014 approval date, the primary composition of matter patents would likely have an initial term extending approximately 20 years from the filing date, potentially with patent term extensions (PTEs) granted by regulatory authorities to compensate for regulatory review delays.
  • Method of Use Patents: These patents cover specific therapeutic applications of the drug, such as its use in treating GT1 HCV infection with or without cirrhosis.
  • Formulation Patents: These patents protect the specific dosage forms and delivery systems used in VIEKIRA PAK.
  • Data Exclusivity: In addition to patent protection, regulatory agencies grant periods of data exclusivity upon drug approval. In the United States, New Chemical Entity (NCE) exclusivity typically lasts for 5 years. For VIEKIRA PAK, as a new combination product, the exact nature and duration of exclusivity granted would depend on the specific regulatory pathways pursued. In Europe, a similar framework exists with market protection periods.

Generic Competition Outlook:

The expiration of key composition of matter patents is the primary trigger for generic competition. While specific patent expiry dates can be complex due to multiple patents, patent challenges, and PTEs, the core patents protecting the APIs in VIEKIRA PAK would have begun to expire in the late 2020s and early 2030s.

  • Early Market Entry for Generics: Once the foundational patents expire and any granted PTEs lapse, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with the FDA. The first generic to file a successful ANDA may be eligible for 180 days of market exclusivity.
  • Impact of Mavyret: AbbVie's own introduction of Mavyret, which offers broader coverage and a shorter treatment regimen, significantly predated the full expiration of VIEKIRA PAK's core patents. Mavyret itself is now facing or will soon face generic competition as its patent protection also nears expiration.
  • Declining Market Size: The overall market for HCV treatments has contracted due to the high cure rates achieved with DAAs and the shrinking pool of untreated patients. This smaller market size means that the financial impact of generic entry on a drug like VIEKIRA PAK may be less dramatic than for blockbuster drugs in larger, growing therapeutic areas.

Summary of Exclusivity Considerations:

  • Patent Term Extension (PTE): Likely applied to extend patent life beyond the standard 20 years from filing, compensating for FDA review time.
  • Orphan Drug Exclusivity: Not applicable to VIEKIRA PAK, as it was not designated as an orphan drug.
  • New Chemical Entity (NCE) Exclusivity: Potentially granted for novel components, contributing to market protection.
  • Generic Entry Timing: Dependent on the expiration of core composition of matter patents and PTEs, anticipated in the late 2020s to early 2030s. The commercial impact will be mitigated by the drug's declining market share and the overall market contraction.

The strategic introduction of Mavyret by AbbVie was a proactive measure to maintain market leadership in HCV, effectively managing the lifecycle of its HCV franchise in anticipation of VIEKIRA PAK's eventual patent expiry and the broader market shifts.

What is the Competitive Landscape and its Impact on VIEKIRA PAK?

The hepatitis C market at the time of VIEKIRA PAK's launch was characterized by rapid scientific advancement and intense competition from multiple pharmaceutical companies. This dynamic environment profoundly impacted VIEKIRA PAK's market penetration, pricing power, and long-term financial outlook.

Key Competitors and Regimens:

  1. Gilead Sciences:

    • Sovaldi (sofosbuvir): Approved in December 2013, Sovaldi was a foundational DAA, often used in combination with other agents.
    • Harvoni (ledipasvir/sofosbuvir): Approved in October 2014, Harvoni was a pan-genotypic, all-oral, single-tablet regimen for GT1 HCV, directly competing with VIEKIRA PAK. Its broad applicability and convenience made it a formidable competitor.
    • Epclusa (sofosbuvir/velpatasvir): Approved in June 2016, Epclusa offered pan-genotypic coverage for all six major HCV genotypes, further intensifying competition and offering a more comprehensive solution.
  2. Merck & Co.:

    • Zepatier (elbasvir/grazoprevir): Approved in January 2016, Zepatier offered a combination regimen for GT1 and GT4 HCV, providing another alternative to VIEKIRA PAK and Harvoni.
  3. AbbVie's Mavyret (glecaprevir/pibrentasvir):

    • Approved in August 2017, Mavyret was AbbVie's next-generation HCV treatment. It provided pan-genotypic coverage and a shorter treatment duration (8 weeks for most patients), positioning it as a superior option to VIEKIRA PAK and other earlier regimens. Mavyret effectively superseded VIEKIRA PAK within AbbVie's own portfolio.

Impact of Competition:

  • Pricing Wars and Rebates: The sheer number of highly effective DAA regimens led to aggressive price negotiations with payers and PBMs. This resulted in significant price reductions through rebates and discounts, impacting the net sales of all HCV drugs, including VIEKIRA PAK. While list prices were high, actual realized prices were considerably lower.
  • Market Share Erosion: Gilead's Harvoni, with its pan-genotypic coverage, quickly captured significant market share. VIEKIRA PAK, being primarily indicated for GT1, faced a more limited patient pool compared to pan-genotypic options.
  • Accelerated Obsolescence: The rapid pace of innovation meant that newer, more effective, or more convenient regimens could quickly make older ones less attractive, even if they were still clinically effective. Mavyret's approval accelerated this process for VIEKIRA PAK.
  • Shifting Treatment Paradigms: The widespread success of DAAs led to a rapid decline in the prevalence of treated HCV patients. The market shifted from rapid growth to a more mature and contracting phase, further reducing the commercial opportunity for single-genotype or older DAA regimens.
  • R&D Prioritization: Pharmaceutical companies increasingly focused their R&D efforts on next-generation treatments or other therapeutic areas as the HCV market matured and became highly competitive, impacting the long-term investment in VIEKIRA PAK.

The competitive landscape therefore dictated that VIEKIRA PAK's commercial success was constrained from its inception. Its ability to capture and retain market share was constantly challenged by superior or broader-acting competitor products, ultimately limiting its financial trajectory and leading to its eventual obsolescence within AbbVie's HCV portfolio.

What are the Regulatory and Reimbursement Challenges?

Navigating the regulatory approval process and securing favorable reimbursement for VIEKIRA PAK were critical steps in its market introduction and commercialization. These processes presented significant hurdles, common to high-cost, innovative therapies, and were compounded by the unique dynamics of the HCV market.

Regulatory Pathway:

  • FDA Review: VIEKIRA PAK underwent a standard review process by the U.S. Food and Drug Administration (FDA). Its approval in December 2014 was based on data from Phase III clinical trials (e.g., the SAPPHIRE-I and SAPPHIRE-II studies) demonstrating high SVR rates in patients with GT1 HCV.
  • Labeling Restrictions: The initial indication was for GT1 HCV. While effective, this specificity limited its addressable patient population compared to pan-genotypic regimens approved later.
  • Combination Approval: As a fixed-dose combination, the review process also assessed the safety and efficacy of the co-formulated components and their interactions.

Reimbursement Landscape:

  • High Cost of DAAs: Direct-acting antivirals, including VIEKIRA PAK, were introduced at high price points. This triggered significant concerns from payers (insurance companies, PBMs, government programs like Medicare and Medicaid) regarding the affordability and cost-effectiveness of these therapies.
  • Payer Restrictions: To manage costs, payers implemented various access restrictions:
    • Prior Authorization: Requiring physicians to obtain approval before prescribing the drug, often necessitating proof of disease severity, prior treatment failure, or specific genotype.
    • Step Therapy: Mandating that patients try less expensive or older treatments first before approving a newer, more expensive DAA like VIEKIRA PAK.
    • Formulary Exclusions: Excluding certain drugs from preferred placement on formularies, making them less accessible or more expensive for patients.
    • Quantity Limits: Restricting the amount of medication a patient could receive within a given timeframe.
  • PBM Negotiations: Pharmacy Benefit Managers (PBMs) played a crucial role in negotiating rebates and discounts with manufacturers. These negotiations significantly influenced the net price of VIEKIRA PAK and were a key determinant of its formulary placement and patient access.
  • Value-Based Agreements: In some instances, payers explored value-based agreements where payment was tied to treatment outcomes (e.g., achieving SVR). While not universally adopted, these models aimed to align payer and manufacturer interests.
  • Competition's Role in Reimbursement: The availability of multiple highly effective DAAs from competitors like Gilead created leverage for payers. They could demand steeper discounts and more favorable terms to include a drug like VIEKIRA PAK on their formularies, especially when pan-genotypic options offered broader coverage.
  • AbbVie's Strategy with Mavyret: AbbVie's subsequent launch of Mavyret, with its pan-genotypic coverage and shorter treatment duration, was also informed by reimbursement challenges. Mavyret was designed to be a more competitive offering from a cost-effectiveness and access perspective, particularly given its shorter treatment course.

The reimbursement environment for VIEKIRA PAK was therefore characterized by a constant tension between the clinical need for curative HCV therapies and the economic pressures on healthcare systems. Successfully navigating these challenges required extensive health economics and outcomes research, robust market access teams, and a willingness to engage in complex negotiations with payers and PBMs. The success of VIEKIRA PAK, like other DAAs, was as much a function of payer acceptance and formulary access as it was of its clinical efficacy.

What is the Future Outlook for VIEKIRA PAK?

The future outlook for VIEKIRA PAK is one of continued decline and eventual market withdrawal, driven by the natural evolution of the pharmaceutical market, competitive pressures, and the success of next-generation therapies.

Key Factors Influencing Future Trajectory:

  • Continued Market Contraction: The global market for hepatitis C treatments is contracting. The initial wave of treatment needs has largely been met. The remaining patient pool is smaller, often more complex to treat (e.g., individuals with treatment-experienced cases, liver disease, or co-infections), or faces access barriers.
  • Dominance of Next-Generation DAAs: AbbVie's own Mavyret, along with other pan-genotypic regimens, has largely replaced VIEKIRA PAK in clinical practice due to its broader genotype coverage, shorter treatment duration, and demonstrated real-world effectiveness. Mavyret's 8-week curative regimen for most patients has become the standard of care.
  • Generic Competition Anticipation: As mentioned previously, the expiration of key patents protecting VIEKIRA PAK's active ingredients will pave the way for generic versions. While the market size will likely be small by the time generics enter, it will further erode any remaining revenue.
  • AbbVie's Portfolio Prioritization: AbbVie will continue to prioritize marketing and sales efforts on its more advanced and commercially successful HCV products, primarily Mavyret. Investment in VIEKIRA PAK will be minimal.
  • Limited New Indications or Development: It is highly unlikely that VIEKIRA PAK will see significant new indications or further clinical development. Its therapeutic niche has been fully occupied by superior alternatives.
  • Potential for Obsolescence and Discontinuation: As sales dwindle and it becomes commercially unviable to maintain the product, AbbVie may eventually choose to discontinue VIEKIRA PAK. This decision would be based on sales volume, manufacturing costs, and strategic portfolio management.

Projected Sales Trajectory:

AbbVie's financial reports have already shown a dramatic decrease in HCV product sales attributed to VIEKIRA PAK and its associated components. This trend is expected to continue with sales reaching negligible levels in the coming years.

  • Near-term (1-2 years): Sales will likely remain low, primarily serving residual demand or specific patient populations not covered by newer regimens.
  • Mid-term (3-5 years): Generic entry could commence, further diminishing sales. AbbVie may begin phasing out support for the product.
  • Long-term (5+ years): VIEKIRA PAK is expected to be effectively obsolete, with very limited or no commercial presence.

The trajectory of VIEKIRA PAK serves as a case study for the rapid lifecycle of innovative drugs in highly competitive therapeutic areas. Despite its initial success as a groundbreaking DAA, its market position was transient, superseded by subsequent innovations.

Key Takeaways

  • VIEKIRA PAK, an early direct-acting antiviral regimen for genotype 1 hepatitis C, achieved significant initial sales for AbbVie but experienced a rapid decline due to intense competition and market evolution.
  • AbbVie's HCV franchise sales peaked in 2016 and have since significantly contracted, with VIEKIRA PAK being largely superseded by AbbVie's own pan-genotypic Mavyret.
  • Key patents protecting VIEKIRA PAK's active ingredients are expected to expire in the late 2020s to early 2030s, opening the door for generic competition, though the market size will be considerably smaller.
  • The competitive landscape, dominated by pan-genotypic regimens from Gilead Sciences and subsequently AbbVie's own Mavyret, eroded VIEKIRA PAK's market share and contributed to pricing pressures.
  • Regulatory approval was followed by significant reimbursement challenges, including payer restrictions and intense price negotiations, which impacted net sales and market access.
  • The future outlook for VIEKIRA PAK is one of continued decline and eventual obsolescence, as market contraction, the dominance of next-generation therapies, and generic entry render it commercially unviable.

Frequently Asked Questions

1. When did VIEKIRA PAK receive U.S. FDA approval?

VIEKIRA PAK received U.S. FDA approval in December 2014.

2. What hepatitis C genotypes is VIEKIRA PAK indicated for?

VIEKIRA PAK is indicated for adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

3. Did AbbVie develop any successor drugs to VIEKIRA PAK?

Yes, AbbVie developed Mavyret (glecaprevir/pibrentasvir), a pan-genotypic and shorter-duration regimen, which has largely replaced VIEKIRA PAK within AbbVie's portfolio.

4. What is the primary reason for VIEKIRA PAK's declining sales?

The primary reasons for VIEKIRA PAK's declining sales include intense competition from other direct-acting antivirals (especially pan-genotypic ones), the evolution of treatment standards to include newer, more effective regimens, and the natural contraction of the overall hepatitis C treatment market.

5. When can generic versions of VIEKIRA PAK be expected?

Generic versions of VIEKIRA PAK are anticipated to become available following the expiration of key composition of matter patents and any associated patent term extensions, which are generally expected in the late 2020s to early 2030s.

Citations

[1] AbbVie Inc. (2016). AbbVie Reports Fourth Quarter and Full Year 2015 Financial Results. [Press Release]. [2] AbbVie Inc. (2017). AbbVie Reports Fourth Quarter and Full Year 2016 Financial Results. [Press Release]. [3] AbbVie Inc. (2018). AbbVie Reports Fourth Quarter and Full Year 2017 Financial Results. [Press Release]. [4] AbbVie Inc. (2019). AbbVie Reports Fourth Quarter and Full Year 2018 Financial Results. [Press Release]. [5] AbbVie Inc. (2020). AbbVie Reports Fourth Quarter and Full Year 2019 Financial Results. [Press Release]. [6] AbbVie Inc. (2021). AbbVie Reports Fourth Quarter and Full Year 2020 Financial Results. [Press Release].

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