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Ocaliva patents expiration

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

(1 year, 5 months ago)

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

(2 years from now)

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

(9 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).
US8377916 INTERCEPT PHARMS INC Steroids as agonists for FXR
Feb, 2022

(2 years ago)

US8058267 INTERCEPT PHARMS INC Steroids as agonists for FXR
Feb, 2022

(2 years ago)

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

(9 years from now)

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

(9 years from now)

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

(12 years from now)

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

(12 years from now)

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

(12 years from now)

Ocaliva is owned by Intercept Pharms Inc.

Ocaliva contains Obeticholic Acid.

Ocaliva has a total of 10 drug patents out of which 3 drug patents have expired.

Expired drug patents of Ocaliva are:

  • US8377916
  • US8058267
  • US7138390

Ocaliva was authorised for market use on 27 May, 2016.

Ocaliva is available in tablet;oral dosage forms.

Ocaliva can be used as 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 monotherapy in adults unable to tolerate udca.

Drug patent challenges can be filed against Ocaliva from 27 May, 2020.

The generics of Ocaliva are possible to be released after 26 April, 2036.

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

Drugs and Companies using OBETICHOLIC ACID ingredient

NCE-1 date: 27 May, 2020

Market Authorisation Date: 27 May, 2016

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...

Dosage: TABLET;ORAL

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

OCALIVA family patents

Family Patents