Liver Disease Therapeutics

1. Doptelet patent expiration

Treatment: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure; Treatment of thrombocy...

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.
US7638536 AKARX INC 2-Acylaminothiazole derivative or salt thereof
Jul, 2027

(1 year, 6 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8765764 AKARX INC 2-acylaminothiazole derivative or salt thereof
Jan, 2023

(2 years ago)

US8338429 AKARX INC 2-acylaminothiazole derivative or salt thereof
Jun, 2023

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-802) Jun 26, 2022
New Chemical Entity Exclusivity(NCE) May 21, 2023
Orphan Drug Exclusivity(ODE-246) Jun 26, 2026
New Indication(I-974) Jul 24, 2028

Drugs and Companies using AVATROMBOPAG MALEATE ingredient

NCE-1 date: 21 May, 2022

Market Authorisation Date: 21 May, 2018

Dosage: TABLET

More Information on Dosage

DOPTELET family patents

Family Patents

2. Iqirvo patent expiration

Treatment: Treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults who have had an inadequate response to udca, or as monotherapy in patients unable to tolerate u...

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.
US7943661 IPSEN Substituted 1,3-diphenylprop-2-en-1-one derivatives and preparation and uses thereof
Sep, 2024

(1 year, 3 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11857523 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US11331292 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US11185519 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US12310935 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US12295928 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US12295927 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US7632870 IPSEN Composition based on substituted 1,3-diphenylprop-2-en-1-one derivatives, preparation and uses thereof
Sep, 2024

(1 year, 3 months ago)

US11850223 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)

US12233038 IPSEN Methods of treatment of cholestatic diseases
Mar, 2037

(11 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 10, 2029
Orphan Drug Exclusivity(ODE-486) Jun 10, 2031

Drugs and Companies using ELAFIBRANOR ingredient

NCE-1 date: 10 June, 2028

Market Authorisation Date: 10 June, 2024

Dosage: TABLET

More Information on Dosage

IQIRVO 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. Livdelzi patent expiration

Treatment: Treatment of primary biliary cholangitis (pbc)

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.
US7709682 GILEAD SCIENCES INC Lysine salts of 4-((phenoxyalkyl)thio)-phenoxyacetic acid derivatives
Sep, 2026

(8 months from now)

US7301050 GILEAD SCIENCES INC 4-((phenoxyalkyl)thio)-phenoxyacetic acids and analogs
Aug, 2026

(6 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11596614 GILEAD SCIENCES INC Treatment of intrahepatic cholestatic diseases
Mar, 2035

(9 years from now)

US11406611 GILEAD SCIENCES INC Treatment of intrahepatic cholestatic diseases
Mar, 2035

(9 years from now)

US10272058 GILEAD SCIENCES INC Treatment of intrahepatic cholestatic diseases
Mar, 2035

(9 years from now)

US9486428 GILEAD SCIENCES INC Treatment of intrahepatic cholestatic diseases
Mar, 2035

(9 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 14, 2029
Orphan Drug Exclusivity(ODE-486) Aug 14, 2031

Drugs and Companies using SELADELPAR LYSINE ingredient

NCE-1 date: 14 August, 2028

Market Authorisation Date: 14 August, 2024

Dosage: CAPSULE

More Information on Dosage

LIVDELZI family patents

Family Patents

4. Livmarli patent expiration

Treatment: Treatment of cholestatic pruritus in patients with alagille syndrome (algs); Treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis...

Can you believe LIVMARLI received compensation for the extended wait time during the regulatory approval process?
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).
US11497745 MIRUM Methods for treating cholestasis
Feb, 2040

(14 years from now)

US11260053 MIRUM Bile acid recycling inhibitors and satiogens for treatment of diabetes, obesity, and inflammatory gastrointestinal conditions
May, 2031

(5 years from now)

US11229661 MIRUM Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Oct, 2032

(6 years from now)

US11229647 MIRUM Methods for treating cholestasis
Feb, 2040

(14 years from now)

US10512657 MIRUM Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Oct, 2032

(6 years from now)

US11376251 MIRUM Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases
Oct, 2032

(6 years from now)

US12350267 MIRUM NA
Oct, 2032

(6 years from now)

US12296050 MIRUM Pharmaceutical compositions comprising maralixibat and uses thereof
Oct, 2043

(17 years from now)

US11918578 MIRUM Methods for treating cholestasis
Feb, 2040

(14 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Mar 13, 2026
New Chemical Entity Exclusivity(NCE) Sep 29, 2026
New Indication(I-938) Mar 13, 2027
Orphan Drug Exclusivity(ODE-379) Sep 29, 2028
Orphan Drug Exclusivity(ODE-429) Mar 13, 2030
ODE*(ODE*) Mar 13, 2031
Orphan Drug Exclusivity(ODE-471) Mar 13, 2031
Orphan Drug Exclusivity(ODE-490) Jul 24, 2031

Drugs and Companies using MARALIXIBAT CHLORIDE ingredient

NCE-1 date: 29 September, 2025

Market Authorisation Date: 10 April, 2025

Dosage: TABLET; SOLUTION

More Information on Dosage

LIVMARLI family patents

Family Patents

5. Mulpleta patent expiration

Treatment: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure

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.
US7601746 VANCOCIN ITALIA Compounds exhibiting thrombopoietin receptor agonism
Sep, 2024

(1 year, 4 months ago)

US8889722 VANCOCIN ITALIA Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
Jul, 2028

(2 years from now)

US8530668 VANCOCIN ITALIA Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
Jan, 2030

(4 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).
US9427402 VANCOCIN ITALIA Preparation for improving solubility of poorly soluble drug
Sep, 2031

(5 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 31, 2023

Drugs and Companies using LUSUTROMBOPAG ingredient

NCE-1 date: 31 July, 2022

Market Authorisation Date: 31 July, 2018

Dosage: TABLET

More Information on Dosage

MULPLETA family patents

Family Patents

6. Ocaliva patent expiration

Treatment: Treatment of primary biliary cholangitis (pbc); Treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca, or as mono...

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.
US7138390 INTERCEPT PHARMS INC Steroids as agonists for FXR
Nov, 2022

(3 years ago)

US10174073 INTERCEPT PHARMS INC Preparation and uses of obeticholic acid
Jun, 2033

(7 years from now)

USRE48286 INTERCEPT PHARMS INC Steroids as agonists for FXR
Feb, 2027

(1 year, 1 month from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8058267 INTERCEPT PHARMS INC Steroids as agonists for FXR
Feb, 2022

(3 years ago)

US8377916 INTERCEPT PHARMS INC Steroids as agonists for FXR
Feb, 2022

(3 years ago)

US10047117 INTERCEPT PHARMS INC Preparation and uses of obeticholic acid
Sep, 2033

(7 years from now)

US10758549 INTERCEPT PHARMS INC Compositions of obeticholic acid and methods of use
Apr, 2036

(10 years from now)

US10751349 INTERCEPT PHARMS INC Compositions of obeticholic acid and methods of use
Apr, 2036

(10 years from now)

US10052337 INTERCEPT PHARMS INC Compositions of obeticholic acid and methods of use
Apr, 2036

(10 years from now)

US9238673 INTERCEPT PHARMS INC Preparation and uses of obeticholic acid
Jun, 2033

(7 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 27, 2021
Orphan Drug Exclusivity(ODE) May 27, 2023
Orphan Drug Exclusivity(ODE-119) May 27, 2023

Drugs and Companies using OBETICHOLIC ACID ingredient

NCE-1 date: 27 May, 2020

Market Authorisation Date: 27 May, 2016

Dosage: TABLET

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

OCALIVA family patents

Family Patents

7. Rezdiffra patent expiration

Treatment: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (nash) with moderate to advanced liver fibrosis (consistent with stages f2 to f3 fibrosis)

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.
US11564926 MADRIGAL Methods of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(7 years from now)

US9266861 MADRIGAL Method of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(7 years from now)

US7452882 MADRIGAL Thyroid hormone analogs
Sep, 2026

(8 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11986481 MADRIGAL Method of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(7 years from now)

US10376517 MADRIGAL Methods of synthesizing thyroid hormone analogs and polymorphs thereof
Sep, 2033

(7 years from now)

US12377104 MADRIGAL NA
Feb, 2045

(19 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 14, 2029

Drugs and Companies using RESMETIROM ingredient

NCE-1 date: 14 March, 2028

Market Authorisation Date: 14 March, 2024

Dosage: TABLET

More Information on Dosage

REZDIFFRA family patents

Family Patents

8. Terlivaz patent expiration

Treatment: A method to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function

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).
US10335452 MALLINCKRODT IRELAND Method of treating patients with hepatorenal syndrome type 1
Apr, 2037

(11 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Sep 14, 2027
Orphan Drug Exclusivity(ODE-406) Sep 14, 2029

Drugs and Companies using TERLIPRESSIN ACETATE ingredient

NCE-1 date: 14 September, 2026

Market Authorisation Date: 14 September, 2022

Dosage: POWDER

More Information on Dosage

TERLIVAZ family patents

Family Patents