Eculizumab - Biologic Drug Details
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Summary for eculizumab
| Tradenames: | 1 |
| High Confidence Patents: | 3 |
| Applicants: | 1 |
| BLAs: | 1 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for eculizumab |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for eculizumab |
Recent Clinical Trials for eculizumab
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Alexion | N/A |
| AstraZeneca | N/A |
| Alexion | Phase 3 |
Recent Litigation for eculizumab
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 eculizumab
| 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 eculizumab Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for eculizumab 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 eculizumab 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 |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for eculizumab
Supplementary Protection Certificates for eculizumab
| 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 | |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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