TRALEMENT Drug Patent Profile
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Which patents cover Tralement, and when can generic versions of Tralement launch?
Tralement is a drug marketed by Am Regent and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has six patent family members in six countries.
The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this compound. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Tralement
Tralement was eligible for patent challenges on April 30, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 1, 2041. This may change due to patent challenges or generic licensing.
There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Questions you can ask:
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Summary for TRALEMENT
International Patents: | 6 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 2 |
Drug Prices: | Drug price information for TRALEMENT |
What excipients (inactive ingredients) are in TRALEMENT? | TRALEMENT excipients list |
DailyMed Link: | TRALEMENT at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRALEMENT
Generic Entry Date for TRALEMENT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for TRALEMENT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
American Regent, Inc. | Phase 4 |
Pharmacology for TRALEMENT
Drug Class | Copper Absorption Inhibitor Paramagnetic Contrast Agent |
Mechanism of Action | Magnetic Resonance Contrast Activity |
Physiological Effect | Decreased Copper Ion Absorption |
Paragraph IV (Patent) Challenges for TRALEMENT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TRALEMENT | Injection | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | 0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL) | 209376 | 1 | 2023-11-16 |
TRALEMENT | Injection | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | 0.3 mg/mL, 55 mcg/mL, 60 mcg/mL, 3 mg/mL (5 mL) | 209376 | 3 | 2023-11-14 |
US Patents and Regulatory Information for TRALEMENT
TRALEMENT is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRALEMENT is ⤷ Try for Free.
This potential generic entry date is based on patent 12,150,957.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
International Patents for TRALEMENT
When does loss-of-exclusivity occur for TRALEMENT?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 21300384
Patent: Trace element compositions, methods of making and use
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 86578
Patent: COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
Estimated Expiration: ⤷ Try for Free
China
Patent: 6096423
Patent: 微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application)
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 75615
Patent: COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE)
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 230058047
Patent: 미량 원소 조성물, 그 제조 및 사용 방법
Estimated Expiration: ⤷ Try for Free
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TRALEMENT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2021300384 | Trace element compositions, methods of making and use | ⤷ Try for Free |
China | 116096423 | 微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application) | ⤷ Try for Free |
European Patent Office | 4175615 | COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2022006426 | ⤷ Try for Free | |
South Korea | 20230058047 | 미량 원소 조성물, 그 제조 및 사용 방법 | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Tralement
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