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.
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.
Summary for TRALEMENT
| US Patents: | 0 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRALEMENT
Generic Entry Date for TRALEMENT*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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 |
Anatomical Therapeutic Chemical (ATC) Classes for TRALEMENT
US Patents and Regulatory Information for TRALEMENT
TRALEMENT is protected by zero US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRALEMENT is ⤷ Try a Trial.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting TRALEMENT
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | TRALEMENT | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376-001 | Jul 2, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Am Regent | TRALEMENT | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376-002 | Dec 2, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
