Promacta Patent Expiration

Promacta is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 28 US drug patents filed from 2013 to 2015. Out of these, 14 drug patents are active and 14 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 01, 2028. Details of Promacta's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7547719 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)
Jul, 2025

(11 months from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6280959 Metal complexes
Oct, 2018

(5 years ago)

Expired
US6280959

(Pediatric)

Metal complexes
Apr, 2019

(5 years ago)

Expired
US7473686 Thrombopoietin mimetics
May, 2021

(3 years ago)

Expired
US7790704 Thrombopoietin mimetics
May, 2021

(3 years ago)

Expired
US7452874 Thrombopoietin mimetics
May, 2021

(3 years ago)

Expired
US7332481 Thrombopoietin mimetics
May, 2021

(3 years ago)

Expired
US7452874

(Pediatric)

Thrombopoietin mimetics
Nov, 2021

(2 years ago)

Expired
US7332481

(Pediatric)

Thrombopoietin mimetics
Nov, 2021

(2 years ago)

Expired
US7473686

(Pediatric)

Thrombopoietin mimetics
Nov, 2021

(2 years ago)

Expired
US7790704

(Pediatric)

Thrombopoietin mimetics
Nov, 2021

(2 years ago)

Expired
US7160870 Thrombopoietin mimetics
Nov, 2022

(1 year, 7 months ago)

Expired
US7160870

(Pediatric)

Thrombopoietin mimetics
May, 2023

(1 year, 1 month ago)

Expired
US7795293 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
May, 2023

(1 year, 1 month ago)

Expired
US7795293

(Pediatric)

3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Nov, 2023

(7 months ago)

Expired
US7547719

(Pediatric)

3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine)
Jan, 2026

(1 year, 5 months from now)

Active
US8052993 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Aug, 2027

(3 years from now)

Active
US8828430 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Aug, 2027

(3 years from now)

Active
US8062665 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Aug, 2027

(3 years from now)

Active
US8052994 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Aug, 2027

(3 years from now)

Active
US8052995 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Aug, 2027

(3 years from now)

Active
US8071129 3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Aug, 2027

(3 years from now)

Active
US8828430

(Pediatric)

3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Feb, 2028

(3 years from now)

Active
US8052993

(Pediatric)

3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Feb, 2028

(3 years from now)

Active
US8052994

(Pediatric)

3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Feb, 2028

(3 years from now)

Active
US8062665

(Pediatric)

3′-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Feb, 2028

(3 years from now)

Active
US8071129

(Pediatric)

3′-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2′-hydroxy-[1,1′-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Feb, 2028

(3 years from now)

Active
US8052995

(Pediatric)

3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine)
Feb, 2028

(3 years from now)

Active


FDA has granted several exclusivities to Promacta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Promacta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Promacta.

Exclusivity Information

Promacta holds 8 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Promacta's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 20, 2013
New Indication(I-664) Nov 16, 2015
Orphan Drug Exclusivity(ODE) Nov 20, 2015
New Indication(I-711) Jun 11, 2018
New Dosing Schedule(D-149) Jun 11, 2018
Orphan Drug Exclusivity(ODE-75) Aug 26, 2021
Pediatric Exclusivity(PED) Feb 26, 2022
Orphan Drug Exclusivity(ODE-210) Nov 16, 2025

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Several oppositions have been filed on Promacta's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Promacta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Promacta patents.

Promacta's oppositions filed in EPO

Promacta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 27, 2016, by Zbm Patents Aps. This opposition was filed on patent number EP07840632A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP07840632A Sep, 2016 Generics (U.K.) Limited Revoked
EP07840632A Sep, 2016 Galenicum Health S.L. Revoked
EP07840632A Sep, 2016 Teva Pharmaceutical Industries Ltd Revoked
EP07840632A Sep, 2016 Alfred E. Tiefenbacher (GmbH & Co. KG) Revoked
EP07840632A Sep, 2016 ZBM Patents ApS Revoked


US patents provide insights into the exclusivity only within the United States, but Promacta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Promacta's family patents as well as insights into ongoing legal events on those patents.

Promacta's family patents

Promacta has patent protection in a total of 43 countries. It's US patent count contributes only to 22.4% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Promacta.

Family Patents

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Generic Launch

Generic Release Date:

Promacta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 01, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Promacta Generics:

Eltrombopag Olamine is the generic name for the brand Promacta. 1 company has already filed for the generic of Promacta. Check out the entire list of companies who have already received approval for Promacta's generic

How can I launch a generic of Promacta before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Promacta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Promacta's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Promacta -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
50 mg and 75 mg 07 Jan, 2014 1 01 Feb, 2028
12.5 mg and 25 mg 04 Feb, 2014 1 01 Feb, 2028




About Promacta

Promacta is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating autoimmune disorders and boosting platelet count in certain patients with hepatitis C. Promacta uses Eltrombopag Olamine as an active ingredient. Promacta was launched by Novartis in 2011.

Market Authorisation Date:

Promacta was approved by FDA for market use on 20 October, 2011.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Promacta is 20 October, 2011, its NCE-1 date is estimated to be 26 February, 2021

Active Ingredient:

Promacta uses Eltrombopag Olamine as the active ingredient. Check out other Drugs and Companies using Eltrombopag Olamine ingredient

Treatment:

Promacta is used for treating autoimmune disorders and boosting platelet count in certain patients with hepatitis C.

Dosage:

Promacta is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 12.5MG ACID TABLET Prescription ORAL
EQ 50MG ACID TABLET Prescription ORAL
EQ 25MG ACID TABLET Prescription ORAL
EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET Discontinued ORAL
EQ 75MG ACID TABLET Prescription ORAL