Chronic Hepatitis C Therapeutics

1. Daklinza patent expiration

Treatment: Method of inhibiting hepatitis c virus; Method of inhibiting hepatitis c virus with daklinza and at least one additional compound having anti-hcv activity

DAKLINZA IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9421192 BRISTOL MYERS Hepatitis C virus inhibitors
Aug, 2027

(1 year, 5 months from now)

US8629171 BRISTOL MYERS Crystalline form of methyl ((1S)-1-((25)-2-(5-(4'-(2-((25)-1((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-2-pyrrolidinyl)-1H-imidazol-2-yl)-1-pyrrolidinyl)carbonyl)-2-methylpropyl)carbamate dihydrochloride salt
Jun, 2031

(5 years from now)

US8642025 BRISTOL MYERS Hepatitis C virus inhibitors
Aug, 2027

(1 year, 5 months from now)

US8329159 BRISTOL MYERS Hepatitis C virus inhibitors
Jul, 2029

(3 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8900566 BRISTOL MYERS Hepatitis C virus inhibitors
Aug, 2027

(1 year, 5 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-161) Feb 05, 2019
New Dosing Schedule(D-162) Feb 05, 2019
New Indication(I-726) Feb 05, 2019
New Indication(I-727) Feb 05, 2019
New Chemical Entity Exclusivity(NCE) Jul 24, 2020

Drugs and Companies using DACLATASVIR DIHYDROCHLORIDE ingredient

NCE-1 date: 25 July, 2019

Market Authorisation Date: 24 July, 2015

Dosage: TABLET

More Information on Dosage

DAKLINZA family patents

Family Patents

2. Incivek patent expiration

Treatment: Method of treating chronic hepatitis c

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7820671 VERTEX Peptidomimetic protease inhibitors
Feb, 2025

(11 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8431615 VERTEX Dose forms
May, 2028

(2 years from now)

US8529882 VERTEX Peptidomimetic protease inhibitors
Aug, 2021

(4 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 23, 2016

Drugs and Companies using TELAPREVIR ingredient

NCE-1 date: 24 May, 2015

Market Authorisation Date: 23 May, 2011

Dosage: TABLET

More Information on Dosage

INCIVEK family patents

Family Patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. Olysio patent expiration

Treatment: Method of treating hepatitis c

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8349869 JANSSEN Macrocylic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)

US8754106 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)

US8741926 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)

US9040562 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)

US8148399 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Sep, 2029

(3 years from now)

US9856265 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)

US7671032 JANSSEN HCV NS-3 serine protease inhibitors
May, 2025

(9 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9353103 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)

US9623022 JANSSEN Macrocyclic inhibitors of hepatitis C virus
Jul, 2026

(5 months from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-697) Nov 05, 2017
New Dosing Schedule(D-151) Oct 05, 2018
New Indication(I-717) Oct 05, 2018
New Chemical Entity Exclusivity(NCE) Nov 22, 2018
M(M-171) Feb 26, 2019
M(M-179) May 20, 2019

Drugs and Companies using SIMEPREVIR SODIUM ingredient

NCE-1 date: 22 November, 2017

Market Authorisation Date: 22 November, 2013

Dosage: CAPSULE

More Information on Dosage

OLYSIO family patents

Family Patents

4. Rebetol patent expiration

Treatment: Method of using ribavirin in combination with pegylated interferon alpha-2b to treat patients with chronic hepatitis c; Method of using riba...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6524570 SCHERING Polyethylene glycol modified interferon therapy
Nov, 2016

(9 years ago)

US6524570

(Pediatric)

SCHERING Polyethylene glycol modified interferon therapy
May, 2017

(8 years ago)

US6472373 SCHERING Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Sep, 2017

(8 years ago)

US6461605 SCHERING Continuous low-dose cytokine infusion therapy
Nov, 2016

(9 years ago)

US6177074 SCHERING Polyethylene glycol modified interferon therapy
Nov, 2016

(9 years ago)

US6790837 SCHERING Ribavirin syrup formulations
Apr, 2023

(2 years ago)

US6790837

(Pediatric)

SCHERING Ribavirin syrup formulations
Oct, 2023

(2 years ago)

US6461605

(Pediatric)

SCHERING Continuous low-dose cytokine infusion therapy
May, 2017

(8 years ago)

US6177074

(Pediatric)

SCHERING Polyethylene glycol modified interferon therapy
May, 2017

(8 years ago)

US6172046

(Pediatric)

SCHERING Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
Mar, 2018

(7 years ago)

US6172046 SCHERING Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
Sep, 2017

(8 years ago)

US6472373

(Pediatric)

SCHERING Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Mar, 2018

(7 years ago)




Drugs and Companies using RIBAVIRIN ingredient

Market Authorisation Date: 29 July, 2003

Dosage: SOLUTION

How can I launch a generic of REBETOL before it's drug patent expiration?
More Information on Dosage

REBETOL family patents

Family Patents

5. Rebetol patent expiration

Treatment: Method of tx a pt suspected of having hepatitis c by admin, in combination, a conjugate comprising peg 12000 & interferon alfa-2b in an amt of from 0.5mcg/kg to 2mcg/kg, once weekly, and ribavirin; Me...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6177074

(Pediatric)

MERCK Polyethylene glycol modified interferon therapy
May, 2017

(8 years ago)

US6524570

(Pediatric)

MERCK Polyethylene glycol modified interferon therapy
May, 2017

(8 years ago)

US6472373 MERCK Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Sep, 2017

(8 years ago)

US6172046 MERCK Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
Sep, 2017

(8 years ago)

US6461605 MERCK Continuous low-dose cytokine infusion therapy
Nov, 2016

(9 years ago)

US6172046

(Pediatric)

MERCK Combination therapy for eradicating detectable HCV-RNA in patients having chronic Hepatitis C infection
Mar, 2018

(7 years ago)

US6177074 MERCK Polyethylene glycol modified interferon therapy
Nov, 2016

(9 years ago)

US6472373

(Pediatric)

MERCK Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Mar, 2018

(7 years ago)

US6524570 MERCK Polyethylene glycol modified interferon therapy
Nov, 2016

(9 years ago)

US6461605

(Pediatric)

MERCK Continuous low-dose cytokine infusion therapy
May, 2017

(8 years ago)




Drugs and Companies using RIBAVIRIN ingredient

Market Authorisation Date: 03 June, 1998

Dosage: CAPSULE

How can I launch a generic of REBETOL before it's drug patent expiration?
More Information on Dosage

REBETOL family patents

Family Patents

6. Sovaldi patent expiration

Treatment: For the treatment of hepatitis c; For the treatment of genotype 1, 2, 3 or 4 chronic hepatitis c virus (hcv) infection as a component of a c...

SOVALDI's oppositions filed in EPO
SOVALDI IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9085573 GILEAD NA
Mar, 2028

(2 years from now)

US8334270 GILEAD NA
Mar, 2028

(2 years from now)

US8580765 GILEAD NA
Mar, 2028

(2 years from now)

US7964580 GILEAD NA
Mar, 2029

(3 years from now)

US8618076 GILEAD Nucleoside phosphoramidates
Dec, 2030

(4 years from now)

US9284342 GILEAD Nucleoside phosphoramidates
Sep, 2030

(4 years from now)

US8633309 GILEAD Nucleoside phosphoramidates
Mar, 2029

(3 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8633309

(Pediatric)

GILEAD Nucleoside phosphoramidates
Sep, 2029

(3 years from now)

US8889159 GILEAD Compositions and methods for treating hepatitis C virus
Mar, 2029

(3 years from now)

US9549941 GILEAD Compositions and methods for treating hepatitis C virus
Mar, 2029

(3 years from now)

US8334270

(Pediatric)

GILEAD NA
Sep, 2028

(2 years from now)

US8580765

(Pediatric)

GILEAD NA
Sep, 2028

(2 years from now)

US7964580

(Pediatric)

GILEAD NA
Sep, 2029

(3 years from now)

US8618076

(Pediatric)

GILEAD Nucleoside phosphoramidates
Jun, 2031

(5 years from now)

US8889159

(Pediatric)

GILEAD Compositions and methods for treating hepatitis C virus
Sep, 2029

(3 years from now)

US9085573

(Pediatric)

GILEAD NA
Sep, 2028

(2 years from now)

US9284342

(Pediatric)

GILEAD Nucleoside phosphoramidates
Mar, 2031

(5 years from now)

US9549941

(Pediatric)

GILEAD Compositions and methods for treating hepatitis C virus
Sep, 2029

(3 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 06, 2018
New Patient Population(NPP) Apr 07, 2020
Orphan Drug Exclusivity(ODE) Apr 07, 2024
ODE*(ODE*) Aug 28, 2026
Orphan Drug Exclusivity(ODE-135) Apr 07, 2024
Pediatric Exclusivity(PED) Oct 07, 2024
Orphan Drug Exclusivity(ODE-258) Aug 28, 2026

Drugs and Companies using SOFOSBUVIR ingredient

Market Authorisation Date: 28 August, 2019

Dosage: PELLETS; TABLET

How can I launch a generic of SOVALDI before it's drug patent expiration?
More Information on Dosage

SOVALDI family patents

Family Patents

7. Victrelis patent expiration

Treatment: Treatment of chronic hepatitis c (chc) genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients (>=18 yea...

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE43298 MERCK Peptides as NS3-serine protease inhibitors of hepatitis C virus
Dec, 2024

(1 year, 2 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7772178 MERCK Pharmaceutical formulations and methods of treatment using the same
Nov, 2027

(1 year, 8 months from now)

US8119602 MERCK Administration of HCV protease inhibitors in combination with food to improve bioavailability
Mar, 2027

(1 year, 23 days from now)




Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Feb 13, 2016
M(M-126) Feb 27, 2016
New Chemical Entity Exclusivity(NCE) May 13, 2016

Drugs and Companies using BOCEPREVIR ingredient

NCE-1 date: 14 May, 2015

Market Authorisation Date: 13 May, 2011

Dosage: CAPSULE

More Information on Dosage

VICTRELIS family patents

Family Patents