ARCALYST Drug Profile
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Summary for Tradename: ARCALYST
| High Confidence Patents: | 3 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for ARCALYST |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARCALYST |
Recent Clinical Trials for ARCALYST
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Stanley Cohen | Early Phase 1 |
| Regeneron Pharmaceuticals | Early Phase 1 |
| Regeneron Pharmaceuticals | Phase 2 |
Recent Litigation for ARCALYST
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Janssen Biotech, Inc. v. Amgen Inc. | 2022-11-29 |
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 ARCALYST Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for ARCALYST Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2013-10-20 | Company disclosures |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2018-09-25 | Company disclosures |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2018-09-25 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for ARCALYST Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2034-04-21 | Patent claims search |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2031-03-09 | Patent claims search |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2034-12-04 | Patent claims search |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2037-01-12 | Patent claims search |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2034-08-04 | Patent claims search |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2032-05-11 | Patent claims search |
| Kiniksa Pharmaceuticals (uk), Ltd. | ARCALYST | rilonacept | For Injection | 125249 | ⤷ Try a Trial | 2035-05-12 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for ARCALYST
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1035377 | ⤷ Try a Trial |
| Germany | 69932832 | ⤷ Try a Trial |
| Japan | 2002525119 | ⤷ Try a Trial |
| New Zealand | 510720 | ⤷ Try a Trial |
| Poland | 348529 | ⤷ Try a Trial |
| Japan | 3902728 | ⤷ Try a Trial |
| China | 100345970 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ARCALYST
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 122010000023 | Germany | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023 |
| 2010C/021 | Belgium | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT; AUTHORISATION NUMBER AND DATE: EU/1/09/582/001 20091026 |
| CR 2010 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT; REG. NO/DATE: EU/1/09/582/001 20091023 |
| 15/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023 |
| SPC/GB10/027 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT; REGISTERED: UK EU/1/09/582/001 20091023 |
| 10C0025 | France | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023 |
| SZ 15/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: RILONACEPT |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
