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 three 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.
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:
- What is the 5 year forecast for TRALEMENT?
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- What is Average Wholesale Price for TRALEMENT?
Summary for TRALEMENT
International Patents: | 6 |
US Patents: | 3 |
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 |
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 three US patents and one FDA Regulatory Exclusivity.
International Patents for TRALEMENT
See the table below for patents covering TRALEMENT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 116096423 | 微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application) | ⤷ Subscribe |
European Patent Office | 4175615 | COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2022006426 | ⤷ Subscribe | |
Canada | 3186578 | COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Subscribe |
South Korea | 20230058047 | 미량 원소 조성물, 그 제조 및 사용 방법 | ⤷ Subscribe |
Australia | 2021300384 | Trace element compositions, methods of making and use | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
TRALEMENT Market Analysis and Financial Projection Experimental
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