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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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.
Patents protecting TRALEMENT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting TRALEMENT
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
International Patents for TRALEMENT
See the table below for patents covering TRALEMENT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20230058047 | 미량 원소 조성물, 그 제조 및 사용 방법 | ⤷ Sign Up |
| Australia | 2021300384 | Trace element compositions, methods of making and use | ⤷ Sign Up |
| European Patent Office | 4175615 | COMPOSITIONS D'OLIGO-ÉLÉMENTS, LEURS PROCÉDÉS DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Sign Up |
| China | 116096423 | 微量元素组合物、制备方法及应用 (Microelement composition, preparation method and application) | ⤷ Sign Up |
| Canada | 3186578 | COMPOSITIONS D'OLIGO-ELEMENTS, LEURS PROCEDES DE FABRICATION ET D'UTILISATION (TRACE ELEMENT COMPOSITIONS, METHODS OF MAKING AND USE) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2022006426 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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