REPATHA Drug Profile
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Summary for Tradename: REPATHA
| High Confidence Patents: | 11 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for REPATHA |
| Recent Clinical Trials: | See clinical trials for REPATHA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for REPATHA |
Recent Clinical Trials for REPATHA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | Phase 4 |
| Hamad Medical Corporation | Phase 4 |
| Colorado Prevention Center | Phase 4 |
Recent Litigation for REPATHA
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Baxalta Incorporated v. Genentech, Inc. | 2022-02-10 |
| Amgen Inc. v. Sanofi | 2017-01-11 |
| Amgen Inc. v. Sanofi | 2014-11-16 |
Pharmacology for REPATHA
| Mechanism of Action | PCSK9 Inhibitors |
| Established Pharmacologic Class | PCSK9 Inhibitor |
| Chemical Structure | Antibodies, Monoclonal |
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 REPATHA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for REPATHA Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2027-08-23 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for REPATHA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2032-10-22 | Patent claims search |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2037-07-03 | Patent claims search |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2035-10-12 | Patent claims search |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2037-01-12 | Patent claims search |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2038-10-30 | Patent claims search |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2033-03-14 | Patent claims search |
| Amgen Inc. | REPATHA | evolocumab | Injection | 125522 | ⤷ Sign Up | 2034-09-23 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for REPATHA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20100057070 | ⤷ Sign Up |
| European Patent Office | 2615113 | ⤷ Sign Up |
| South Korea | 101702194 | ⤷ Sign Up |
| South Korea | 101494932 | ⤷ Sign Up |
| Singapore | 10201710183T | ⤷ Sign Up |
| Peru | 20091006 | ⤷ Sign Up |
| Japan | 6638009 | ⤷ Sign Up |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for REPATHA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2016C/030 | Belgium | ⤷ Sign Up | PRODUCT NAME: EVOLOCUMAB; AUTHORISATION NUMBER AND DATE: EU/1/15/1016 20150721 |
| CR 2016 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: EVOLOCUMAB; REG. NO/DATE: EU/1/15/1016 20150721 |
| 300818 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EVOLOCUMAB; REGISTRATION NO/DATE: EU/1/15/1016 20150721 |
| C20160021 | Estonia | ⤷ Sign Up | ;REG NO/DATE: EU/1/15/1016 21.07.2015; NATIONAL AUTHORISATION NUMBER: EMA/690314/2022 15.09.2022 |
| CA 2016 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: EVOLOCUMAB; REG. NO/DATE: EU/1/15/1016 20150721 |
| 122016000059 | Germany | ⤷ Sign Up | PRODUCT NAME: ALIROCUMAB; REGISTRATION NO/DATE: EU/1/15/1031 20150923 |
| 93180 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ALIROCUMAB OU UN DERIVE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (PRALUENT); FIRST REGISTRATION DATE: 20150923 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
