PROLIA Drug Profile
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Summary for Tradename: PROLIA
| High Confidence Patents: | 10 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for PROLIA |
| Recent Clinical Trials: | See clinical trials for PROLIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PROLIA |
Recent Clinical Trials for PROLIA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Aristotle University Of Thessaloniki | Phase 4 |
| Alvotech Swiss AG | Phase 3 |
| mAbxience S.A | Phase 3 |
Recent Litigation for PROLIA
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-04-30 |
Pharmacology for PROLIA
| Mechanism of Action | RANK Ligand Blocking Activity |
| Established Pharmacologic Class | RANK Ligand 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 PROLIA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for PROLIA Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | Company disclosures | |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2016-12-23 | Company disclosures |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2017-04-16 | Company disclosures |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2021-06-26 | Company disclosures |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2016-12-23 | Company disclosures |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2016-12-23 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for PROLIA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2039-02-26 | Patent claims search |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2030-10-06 | Patent claims search |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2032-10-22 | Patent claims search |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2034-07-17 | Patent claims search |
| Amgen Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Sign Up | 2022-03-20 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for PROLIA
Supplementary Protection Certificates for PROLIA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| CA 2010 00033 | Denmark | ⤷ Sign Up | |
| 300467 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100528 |
| 44/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526 |
| SZ 45/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: DENOSUMAB |
| 495 | Finland | ⤷ Sign Up | |
| C300464 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 20100526 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
