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. Promacta's patents have been open to challenges since 26 February, 2021. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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
(2 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
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
(2 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
(2 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
(2 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
(2 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
(2 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
(2 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
(2 years 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
(2 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
(2 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
(2 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
(2 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
(2 years from now) | Active |
|
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
(8 months from now) | Active |
|
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
(1 year, 5 months 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, 11 months ago) |
Expired
|
|
US7160870 (Pediatric) | Thrombopoietin mimetics |
May, 2023
(1 year, 11 months ago) |
Expired
|
| US7160870 | Thrombopoietin mimetics |
Nov, 2022
(2 years ago) |
Expired
|
|
US7790704 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(3 years ago) |
Expired
|
|
US7473686 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(3 years ago) |
Expired
|
|
US7332481 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(3 years ago) |
Expired
|
|
US7452874 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(3 years ago) |
Expired
|
| US7332481 | Thrombopoietin mimetics |
May, 2021
(3 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
|
|
US6280959 (Pediatric) | Metal complexes |
Apr, 2019
(6 years ago) |
Expired
|
| US6280959 | Metal complexes |
Oct, 2018
(6 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Promacta's patents.
Latest Legal Activities on Promacta's Patents
Given below is the list of recent legal activities going on the following patents of Promacta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2023 | US8071129 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2023 | US8062665 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Apr, 2023 | US8052994 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Apr, 2023 | US8052995 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Apr, 2023 | US8052993 |
| Expire Patent Critical | 10 Oct, 2022 | US7790704 |
| Maintenance Fee Reminder Mailed Critical | 25 Apr, 2022 | US7790704 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Mar, 2022 | US7795293 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2022 | US8828430 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Dec, 2020 | US7547719 |
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 Dosing Schedule(D-149) | Jun 11, 2018 |
| New Indication(I-711) | 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
Eltrombopag Olamine is the generic name for the brand Promacta. 2 different companies have already filed for the generic of Promacta, with Hetero Labs Ltd V having the maximum number of approved applications. 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 |
Alternative Brands for Promacta
Promacta which is used for treating autoimmune disorders and boosting platelet count in certain patients with hepatitis C., has several other brand drugs in the same treatment category and using the same active ingredient (Eltrombopag Olamine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Novartis |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Eltrombopag Olamine, Promacta's active ingredient. Check the complete list of approved generic manufacturers for Promacta
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.
Approval Date:
Promacta was approved by FDA for market use on 20 October, 2011.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 50MG ACID | TABLET | Prescription | ORAL |
| EQ 12.5MG ACID | TABLET | Prescription | ORAL |
| EQ 25MG ACID | TABLET | Prescription | ORAL |
| EQ 75MG 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 |