ARANESP Drug Profile
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Summary for Tradename: ARANESP
| High Confidence Patents: | 2 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for ARANESP |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARANESP |
Recent Clinical Trials for ARANESP
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Region Stockholm | Phase 2 |
| Novartis Pharmaceuticals | Phase 1/Phase 2 |
| H. Lee Moffitt Cancer Center and Research Institute | Phase 1/Phase 2 |
Recent Litigation for ARANESP
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Ameranth, Inc. v. Starbucks Corporation | 2013-05-06 |
Pharmacology for ARANESP
| Physiological Effect | Increased Erythroid Cell Production |
| Established Pharmacologic Class | Erythropoiesis-stimulating Agent |
| Chemical Structure | Erythropoietin |
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 ARANESP Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for ARANESP Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2003-12-13 | Company disclosures |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2024-05-15 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for ARANESP Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2033-03-11 | Patent claims search |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2036-04-01 | Patent claims search |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2032-02-15 | Patent claims search |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| Amgen, Inc. | ARANESP | darbepoetin alpha | Injection | 103951 | ⤷ Try a Trial | 2036-06-13 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for ARANESP
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2004331671 | ⤷ Try a Trial |
| Japan | S61501627 | ⤷ Try a Trial |
| Slovakia | 279959 | ⤷ Try a Trial |
| Czech Republic | 443885 | ⤷ Try a Trial |
| Denmark | 172611 | ⤷ Try a Trial |
| Denmark | 0668351 | ⤷ Try a Trial |
| Czech Republic | 291229 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ARANESP
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 01C0050 | France | ⤷ Try a Trial | PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 20010608 |
| SPC/GB01/055 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DARBEPOETIN ALFA; REGISTERED: UK EU/1/01/185/001-030 20010608 |
| SZ 43/2001 | Austria | ⤷ Try a Trial | PRODUCT NAME: DARBEPOETIN-ALFA |
| PA2004015 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DARBEPOETINAS ALFA (ASN30 THR32 VAL87 ASN88 THR90 EPO); REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608 |
| 132001900976055 | Italy | ⤷ Try a Trial | AUTHORISATION NUMBER(S) AND DATE(S): EU/1/01/185/1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18-19- 20-21-22-23-24-25-26-27-28-29-30, 20010608 |
| 10199059 | Germany | ⤷ Try a Trial | PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608 |
| SPC028/2001 | Ireland | ⤷ Try a Trial | SPC028/2001: 20031204, EXPIRES: 20160607 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
