ULTOMIRIS Drug Profile
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Summary for Tradename: ULTOMIRIS
| High Confidence Patents: | 9 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for ULTOMIRIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ULTOMIRIS |
Recent Clinical Trials for ULTOMIRIS
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Regeneron Pharmaceuticals | Phase 3 |
| Alexion Pharmaceuticals | Phase 2/Phase 3 |
| Brigham and Women's Hospital | Phase 3 |
Recent Litigation for ULTOMIRIS
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Chugai Pharmaceutical Co., Ltd. v. Alexion Pharmaceuticals, Inc. | 2018-11-15 |
Pharmacology for ULTOMIRIS
| Mechanism of Action | Complement Inhibitors |
| Established Pharmacologic Class | Complement Inhibitor |
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
- General brand-side 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 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 ULTOMIRIS Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for ULTOMIRIS Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2034-03-07 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2039-01-14 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2038-07-27 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2034-03-07 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2034-03-07 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2034-03-07 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | ULTOMIRIS | ravulizumab-cwvz | Injection | 761108 | ⤷ Sign Up | 2034-03-07 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for ULTOMIRIS Derived from Patent Text Search
No patents found based on company disclosures
International Patents for ULTOMIRIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 035025 | ⤷ Sign Up |
| South Korea | 20230082690 | ⤷ Sign Up |
| Slovenia | 2970455 | ⤷ Sign Up |
| Japan | 2021036870 | ⤷ Sign Up |
| South Korea | 101796886 | ⤷ Sign Up |
| Japan | 6894265 | ⤷ Sign Up |
| Spain | 2589230 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ULTOMIRIS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C03095795/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RAVULIZUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67278 16.02.2023 |
| C03095795/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RAVULIZUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67278 29.08.2023 |
| C02970455/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RAVULIZUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67278 24.08.2021 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
