Darbepoetin alpha - Biologic Drug Details

Summary for darbepoetin alpha

Tradenames:	1
High Confidence Patents:	2
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for darbepoetin alpha

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:

1. 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.

2. 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.

3. 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 darbepoetin alpha Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for darbepoetin alpha Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2003-12-13	Company disclosures
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2024-05-15	Company disclosures

3) Low Certainty: US Patents for darbepoetin alpha Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2033-03-11	Patent claims search
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2039-02-26	Patent claims search
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2031-04-20	Patent claims search
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2036-04-01	Patent claims search
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2032-02-15	Patent claims search
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2039-02-26	Patent claims search
Amgen Inc.	ARANESP	darbepoetin alpha	Injection	103951		2039-02-26	Patent claims search

International Patents for darbepoetin alpha

Country	Patent Number	Estimated Expiration
Germany	10199059
Japan	H1095799
Japan	H1072366
Latvia	10972
Czech Republic	91795
Czech Republic	497290
Hong Kong	1010398

Supplementary Protection Certificates for darbepoetin alpha

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 43/2001	Austria		PRODUCT NAME: DARBEPOETIN-ALFA
10199059	Germany		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608
132001900976055	Italy		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
300075	Netherlands		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 20010608
SPC028/2001	Ireland		SPC028/2001: 20031204, EXPIRES: 20160607
43/2001	Austria		PRODUCT NAME: DARBEPOETIN-ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608
PA2004015	Lithuania		PRODUCT NAME: DARBEPOETINAS ALFA (ASN30 THR32 VAL87 ASN88 THR90 EPO); REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608