SOLIRIS Drug Profile
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Summary for Tradename: SOLIRIS
| High Confidence Patents: | 3 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for SOLIRIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SOLIRIS |
Recent Clinical Trials for SOLIRIS
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Turgut Ardika PTY LTD | Phase 1 |
| NovelMed Therapeutics | Phase 2 |
| Regeneron Pharmaceuticals | Phase 3 |
Recent Litigation for SOLIRIS
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Alexion Pharmaceuticals, Inc. v. Samsung Bioepis Co. Ltd. | 2024-05-20 |
| Alexion Pharmaceuticals, Inc. v. Samsung Bioepis Co. Ltd. | 2024-01-03 |
| Janssen Biotech, Inc. v. Amgen Inc. | 2022-11-29 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Samsung Bioepis Co., Ltd. | 2023-05-31 |
| Samsung Bioepis Co., Ltd. | 2023-05-18 |
| Amgen Inc. | 2019-02-28 |
Pharmacology for SOLIRIS
| 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 SOLIRIS Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for SOLIRIS Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2019-03-12 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2027-03-15 | Company disclosures |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2027-03-15 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for SOLIRIS Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2032-02-15 | Patent claims search |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2034-01-02 | Patent claims search |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2029-11-05 | Patent claims search |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2033-01-04 | Patent claims search |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2039-05-17 | Patent claims search |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2026-09-10 | Patent claims search |
| Alexion Pharmaceuticals, Inc. | SOLIRIS | eculizumab | Injection | 125166 | ⤷ Sign Up | 2033-03-19 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for SOLIRIS
Supplementary Protection Certificates for SOLIRIS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C300433 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620 |
| SPC002/2010 | Ireland | ⤷ Sign Up | SPC002/2010: 20100902, EXPIRES: 20200430 |
| 132010901820871 | Italy | ⤷ Sign Up | PRODUCT NAME: ECULIZUMAB(SOLIRIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/393/001, 20070620 |
| 10C0016 | France | ⤷ Sign Up | PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620 |
| 12/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: ECULIZUMAB; REGISTRATION NO/DATE: EU/1/07/393/001 20070620 |
| CA 2010 00003 | Denmark | ⤷ Sign Up | |
| SPC/GB10/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ECULIZUMAB; REGISTERED: UK EU/1/07/393/001 20070620 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
