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 |
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 |
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 | ⤷ Try a Trial | 2016-12-23 | Company disclosures |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2017-04-16 | Company disclosures |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2021-06-26 | Company disclosures |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2016-12-23 | Company disclosures |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2033-03-11 | Patent claims search |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2030-10-06 | Patent claims search |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2032-10-22 | Patent claims search |
| Amgen, Inc. | PROLIA | denosumab | Injection | 125320 | ⤷ Try a Trial | 2034-07-17 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for PROLIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20190456 | ⤷ Try a Trial |
| Australia | 2019213305 | ⤷ Try a Trial |
| Poland | 336311 | ⤷ Try a Trial |
| Germany | 122010000048 | ⤷ Try a Trial |
| Poland | 190092 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PROLIA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1090039-7.L | Sweden | ⤷ Try a Trial | PRODUCT NAME: DENOSUMAB; REG. NO/DATE: EU/1/10/618/001 20100526 |
| SPC/GB10/044 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DENOSUMAB, IMMUNOGLOBULIN G2, ANTI-(HUMAN TUMOR NECROSIS FACTOR LIGAND SUPERFAMILY MEMBER 11 (HUMAN OSTEOCLAST DIFFERENTIATION FACTOR)) HUMAN MONOCLONAL AMG162 HEAVY CHAIN), DISULPHIDE WITH HUMAN MONOCLONAL AMG162 LIGHT CHAIN, DIMER.; REGISTERED: UK EU/1/10/618/001 20100528; UK EU/1/10/618/002 20100528; UK EU/1/10/618/003 20100528; UK EU/1/10/618/004 20100528 |
| CA 2010 00031 | Denmark | ⤷ Try a Trial | |
| 45/2010 | Austria | ⤷ Try a Trial | PRODUCT NAME: DENOSUMAB; REGISTRATION NO/DATE: EU/1/10/618/001-004 MITTEILUNG 20100528 |
| PA2010013 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DENOSUMABUM; REGISTRATION NO/DATE: EU/1/10/618/001, 2010 05 26, EU/1/10/618/002, 2010 05 26, EU/1/10/618/003, 2010 05 26, EU/1/10/618/004 20100526 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
