UNITUXIN Drug Profile
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Summary for Tradename: UNITUXIN
| High Confidence Patents: | 13 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for UNITUXIN |
Recent Clinical Trials for UNITUXIN
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Prof. Franca Fagioli | Phase 2 |
| Children's Oncology Group | Phase 2 |
| Nationwide Children's Hospital | Phase 1 |
Pharmacology for UNITUXIN
| Mechanism of Action | Glycolipid Disialoganglioside-directed Antibody Interactions |
| Established Pharmacologic Class | Glycolipid Disialoganglioside-directed Antibody |
Note on Biologic Patents
Matching patents to biologic drugs is far more complicated than for small-molecule drugs.
DrugPatentWatch employs three methods to identify biologic patents:
- Brand-side disclosures in response to biosimilar applications
- DrugPatentWatch analysis and company disclosures
- Patents from broad patent text search
These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.
These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
1) High Certainty: US Patents for UNITUXIN Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for UNITUXIN Derived from DrugPatentWatch Analysis and Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| United Therapeutics Corporation | UNITUXIN | dinutuximab | Injection | 125516 | ⤷ Start Trial | 2037-03-16 | DrugPatentWatch analysis and company disclosures |
| United Therapeutics Corporation | UNITUXIN | dinutuximab | Injection | 125516 | ⤷ Start Trial | 2032-10-03 | DrugPatentWatch analysis and company disclosures |
| United Therapeutics Corporation | UNITUXIN | dinutuximab | Injection | 125516 | ⤷ Start Trial | 2039-02-28 | DrugPatentWatch analysis and company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for UNITUXIN Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| United Therapeutics Corporation | UNITUXIN | dinutuximab | Injection | 125516 | ⤷ Start Trial | 2036-08-24 | Patent claims search |
| United Therapeutics Corporation | UNITUXIN | dinutuximab | Injection | 125516 | ⤷ Start Trial | 2037-12-06 | Patent claims search |
| United Therapeutics Corporation | UNITUXIN | dinutuximab | Injection | 125516 | ⤷ Start Trial | 2037-02-13 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for UNITUXIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 202406 | ⤷ Start Trial |
| Canada | 2565961 | ⤷ Start Trial |
| European Patent Office | 2765146 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for UNITUXIN
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 5/2022 | Austria | ⤷ Start Trial | PRODUCT NAME: TAFASITAMAB; REGISTRATION NO/DATE: EU/1/21/1570 (MITTEILUNG) 20210901 |
| C202330027 | Spain | ⤷ Start Trial | PRODUCT NAME: POLVO DESGRASADO DE SEMILLA DE ARACHIS HYPOGAEA L. (CACAHUETES); NATIONAL AUTHORISATION NUMBER: EU/1/20/1495; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1495; DATE OF FIRST AUTHORISATION IN EEA: 20201217 |
| 122023000035 | Germany | ⤷ Start Trial | PRODUCT NAME: ENTFETTETES PULVER VON ARACHIS HYPOGAEA L. SAMEN (ERDNUESSE); REGISTRATION NO/DATE: EU/1/20/1495 20201217 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
