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

See drug prices 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

See all PROLIA clinical trials

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

See all PROLIA litigation

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

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.

General brand-side disclosures

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.

Patents from broad patent text search

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

These patents were obtained from company disclosures

Glossary

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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
>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

These patents were obtained by searching patent claims