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 is one patent protecting this drug and one Paragraph IV challenge.
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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for TRALEMENT
International Patents: | 6 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 2 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for TRALEMENT
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 |
US Patents and Regulatory Information for TRALEMENT
TRALEMENT is protected by one US patents and one FDA Regulatory Exclusivity.
Patents protecting TRALEMENT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting TRALEMENT
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
International Patents for TRALEMENT
See the table below for patents covering TRALEMENT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2022006426 | ⤷ Try a Trial | |
European Patent Office | 4175615 | COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Try a Trial |
Canada | 3186578 | COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Try a Trial |
China | 116096423 | 微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application) | ⤷ Try a Trial |
South Korea | 20230058047 | 미량 원소 조성물, 그 제조 및 사용 방법 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |