Vosoritide - Generic Drug Details

What are the generic sources for vosoritide and what is the scope of freedom to operate?

Vosoritide is the generic ingredient in one branded drug marketed by Biomarin Pharm and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vosoritide has seventy-five patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for vosoritide

International Patents:	75
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	9
Patent Applications:	45
What excipients (inactive ingredients) are in vosoritide?	vosoritide excipients list
DailyMed Link:	vosoritide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for vosoritide

Constraining patent/regulatory exclusivity:

TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES

Dosage:

POWDER;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for vosoritide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Roopa Kanakatti Shankar	Phase 2
UCSF Benioff Children's Hospital Oakland	Phase 1/Phase 2
Andrew Dauber	Phase 2

See all vosoritide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for vosoritide

M05BX	Other drugs affecting bone structure and mineralization
M05B	DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION
M05	DRUGS FOR TREATMENT OF BONE DISEASES
M	Musculo-skeletal system

US Patents and Regulatory Information for vosoritide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	Nov 19, 2021		RX	Yes	Yes
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-001	Nov 19, 2021		RX	Yes	Yes
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	Nov 19, 2021		RX	Yes	Yes
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	Nov 19, 2021		RX	Yes	Yes
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-001	Nov 19, 2021		RX	Yes	Yes			Y	Y
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	Nov 19, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for vosoritide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
BioMarin International Limited	Voxzogo	vosoritide	EMEA/H/C/005475 Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.	Authorised	no	no	yes	2021-08-26

International Patents for vosoritide

Country	Patent Number	Title	Estimated Expiration
Poland	3175863
Japan	7336482
European Patent Office	3328416	UTILISATION DE VARIANTS DU PEPTIDE NATRIURÉTIQUE DE TYPE C POUR TRAITER LES DYSPLASIES DU SQUELETTE (USE OF C-TYPE NATRIURETIC PEPTIDE VARIANTS TO TREAT SKELETAL DYSPLASIA)
Argentina	120933	VARIANTES DE PÉPTIDOS NATRIURÉTICOS DE TIPO C
European Patent Office	4029512	VARIANTES DU PEPTIDE NATRIURÉTIQUE DE TYPE C (VARIANTS OF C-TYPE NATRIURETIC PEPTIDE)
China	102481330	Variants of c-type natriuretic peptide

Supplementary Protection Certificates for vosoritide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2432489	22C1004	France		PRODUCT NAME: VOSORITIDE; REGISTRATION NO/DATE: EU/1/21/1577 20210901
2432489	301162	Netherlands		PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/21/1577 20210901
2432489	2022C/503	Belgium		PRODUCT NAME: VOSORITIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/21/1577 20210901
2432489	C202230004	Spain		PRODUCT NAME: VOSORITIDE; NATIONAL AUTHORISATION NUMBER: EU/1/21/1577; DATE OF AUTHORISATION: 20210826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1577; DATE OF FIRST AUTHORISATION IN EEA: 20210826
2432489	LUC00248	Luxembourg		PRODUCT NAME: VOSORITIDE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/21/1577 20210901
2432489	122022000008	Germany		PRODUCT NAME: VOSORITID IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/21/1577 20210826