Promacta Kit is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 16 US drug patents filed from 2015 to 2019. Out of these, 2 drug patents are active and 14 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 13, 2026. Details of Promacta Kit'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. | |||
| US6280959 | Metal complexes |
Oct, 2018
(5 years ago) |
Expired
|
| US7452874 | Thrombopoietin mimetics |
May, 2021
(3 years ago) |
Expired
|
| US7473686 | Thrombopoietin mimetics |
May, 2021
(3 years ago) |
Expired
|
| US7160870 | Thrombopoietin mimetics |
Nov, 2022
(1 year, 8 months ago) |
Expired
|
| 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 (Pediatric) | Metal complexes |
Apr, 2019
(5 years ago) |
Expired
|
| US7790704 | Thrombopoietin mimetics |
May, 2021
(3 years ago) |
Expired
|
| US7332481 | Thrombopoietin mimetics |
May, 2021
(3 years ago) |
Expired
|
|
US7473686 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(2 years ago) |
Expired
|
|
US7332481 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(2 years ago) |
Expired
|
|
US7790704 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(2 years ago) |
Expired
|
|
US7452874 (Pediatric) | Thrombopoietin mimetics |
Nov, 2021
(2 years ago) |
Expired
|
|
US7160870 (Pediatric) | Thrombopoietin mimetics |
May, 2023
(1 year, 2 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, 2 months 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
(8 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 |
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 Kit's patents.
Latest Legal Activities on Promacta Kit's Patents
Given below is the list of recent legal activities going on the following patents of Promacta Kit.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 10 Oct, 2022 | US7790704 |
| Maintenance Fee Reminder Mailed | 25 Apr, 2022 | US7790704 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Mar, 2022 | US7795293 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Dec, 2020 | US7547719 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jun, 2020 | US7473686 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 May, 2020 | US7452874 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Aug, 2019 | US7332481 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jun, 2018 | US7160870 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Mar, 2018 | US7795293 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Feb, 2018 | US7790704 |
FDA has granted several exclusivities to Promacta Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Promacta Kit, 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 Kit.
Exclusivity Information
Promacta Kit holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Promacta Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-149) | Jun 11, 2018 |
| New Indication(I-711) | Jun 11, 2018 |
| Orphan Drug Exclusivity(ODE-74) | Aug 26, 2021 |
| Orphan Drug Exclusivity(ODE) | Aug 26, 2021 |
| Pediatric Exclusivity(PED) | Feb 26, 2022 |
| ODE*(ODE*) | Nov 16, 2025 |
US patents provide insights into the exclusivity only within the United States, but Promacta Kit 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 Kit's family patents as well as insights into ongoing legal events on those patents.
Promacta Kit's family patents
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Generic Launch
Generic Release Date:
Promacta Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 13, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Promacta Kit Generics:
Eltrombopag Olamine is the generic name for the brand Promacta Kit. 1 company has already filed for the generic of Promacta Kit. Check out the entire list of companies who have already received approval for Promacta Kit's generic
How can I launch a generic of Promacta Kit before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Promacta Kit's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Promacta Kit'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 Kit -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12. mg/packet and 25 mg/packet | 22 Apr, 2022 | 1 | 13 Jul, 2025 |
About Promacta Kit
Promacta Kit is a drug owned by Novartis Pharmaceuticals Corp. It is used for increasing platelet counts in patients with chronic immune thrombocytopenia and chronic hepatitis C to facilitate interferon-based therapy. Promacta Kit uses Eltrombopag Olamine as an active ingredient. Promacta Kit was launched by Novartis in 2018.
Market Authorisation Date:
Promacta Kit was approved by FDA for market use on 27 September, 2018.
Active Ingredient:
Promacta Kit uses Eltrombopag Olamine as the active ingredient. Check out other Drugs and Companies using Eltrombopag Olamine ingredient
Treatment:
Promacta Kit is used for increasing platelet counts in patients with chronic immune thrombocytopenia and chronic hepatitis C to facilitate interferon-based therapy.
Dosage:
Promacta Kit is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 25MG ACID/PACKET | FOR SUSPENSION | Prescription | ORAL |
| EQ 12.5MG ACID/PACKET | FOR SUSPENSION | Prescription | ORAL |