Mulpleta is a drug owned by Vancocin Italia Srl. It is protected by 4 US drug patents filed in 2018. Out of these, 3 drug patents are active and 1 has expired. Mulpleta's patents have been open to challenges since 31 July, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 29, 2031. Details of Mulpleta'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. | |||
| US8530668 | Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor |
Jan, 2030
(4 years from now) | Active |
| US8889722 | Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor |
Jul, 2028
(3 years from now) | Active |
| US7601746 | Compounds exhibiting thrombopoietin receptor agonism |
Sep, 2024
(9 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9427402 | Preparation for improving solubility of poorly soluble drug |
Sep, 2031
(6 years 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 Mulpleta's patents.
Latest Legal Activities on Mulpleta's Patents
Given below is the list of recent legal activities going on the following patents of Mulpleta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Withdrawal of Application for PTE Critical | 06 May, 2024 | US7601746 |
| Patent Term Extension Certificate Critical | 06 May, 2024 | US8889722 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Feb, 2024 | US9427402 |
| Notice of Final Determination -Election Required | 09 Feb, 2024 | US7601746 |
| Notice of Final Determination -Election Required | 09 Feb, 2024 | US8889722 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 02 Feb, 2024 | US7601746 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 02 Feb, 2024 | US8889722 |
| Email Notification Critical | 25 Jan, 2024 | US7601746 |
| Email Notification Critical | 25 Jan, 2024 | US8889722 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Jan, 2024 | US7601746 |
FDA has granted several exclusivities to Mulpleta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mulpleta, 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 Mulpleta.
Exclusivity Information
Mulpleta holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Mulpleta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 31, 2023 |
US patents provide insights into the exclusivity only within the United States, but Mulpleta 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 Mulpleta's family patents as well as insights into ongoing legal events on those patents.
Mulpleta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mulpleta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 29, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mulpleta Generics:
There are no approved generic versions for Mulpleta as of now.
About Mulpleta
Mulpleta is a drug owned by Vancocin Italia Srl. It is used for managing thrombocytopenia in adult patients with chronic liver disease undergoing a procedure. Mulpleta uses Lusutrombopag as an active ingredient. Mulpleta was launched by Vancocin Italia in 2018.
Approval Date:
Mulpleta was approved by FDA for market use on 31 July, 2018.
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 Mulpleta is 31 July, 2018, its NCE-1 date is estimated to be 31 July, 2022.
Active Ingredient:
Mulpleta uses Lusutrombopag as the active ingredient. Check out other Drugs and Companies using Lusutrombopag ingredient
Treatment:
Mulpleta is used for managing thrombocytopenia in adult patients with chronic liver disease undergoing a procedure.
Dosage:
Mulpleta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG | TABLET | Prescription | ORAL |