Tralement is a drug owned by American Regent Inc. It is protected by 3 US drug patents filed from 2023 to 2024 out of which none have expired yet. Tralement's patents have been open to challenges since 01 May, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2041. Details of Tralement's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11998565 | Trace element compositions, methods of making and use |
Jul, 2041
(16 years from now) | Active |
| US11786548 | Trace element compositions, methods of making and use |
Jul, 2041
(16 years from now) | Active |
| US11975022 | Trace element compositions, methods of making and use |
Jul, 2041
(16 years from now) | Active |
FDA has granted several exclusivities to Tralement. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tralement, 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 Tralement.
Exclusivity Information
Tralement holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Tralement's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 30, 2024 |
US patents provide insights into the exclusivity only within the United States, but Tralement 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 Tralement's family patents as well as insights into ongoing legal events on those patents.
Tralement's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tralement's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tralement Generics:
There are no approved generic versions for Tralement as of now.
Alternative Brands for Tralement
There are several other brand drugs using the same active ingredient (Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate) as Tralement. 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 | |
|---|---|---|
| Am Regent |
|
About Tralement
Tralement is a drug owned by American Regent Inc. Tralement uses Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate as an active ingredient. Tralement was launched by Am Regent in 2021.
Approval Date:
Tralement was approved by FDA for market use on 30 June, 2021.
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 Tralement is 30 June, 2021, its NCE-1 date is estimated to be 01 May, 2023.
Active Ingredient:
Tralement uses Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate as the active ingredient. Check out other Drugs and Companies using Cupric Sulfate; Manganese Sulfate; Selenious Acid; Zinc Sulfate ingredient
Dosage:
Tralement is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) | SOLUTION | Prescription | INTRAVENOUS |
| EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) | SOLUTION | Prescription | INTRAVENOUS |