Viewing data from:

VOXZOGO

NDA

VOSORITIDE | N214938 | BIOMARIN PHARMACEUTICAL INC

3 strengths8 unique patents4 unique exclusivities

Patent Timeline

8 unique patents, 4 exclusivities by expiration date

Active (8)TodayExclusivityIPRPTAB Challenge

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

May. 20, 2030

Jun. 11, 2035

Aug. 1, 2036

Aug. 1, 2036

Aug. 1, 2036

Aug. 1, 2036

Jul. 11, 2042PGR×2

Aug. 1, 2036

NPP

Oct. 20, 2026

NCE

Nov. 19, 2026

ODE-387

Nov. 19, 2028

ODE-449

Oct. 20, 2030

PTAB Proceedings

2 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2026-00013	12233106	PGR	Ascendis Pharma A/S et al.	Trial Instituted	2025-11-24	2026-05-06
PGR2026-00055	12233106	PGR	ZYDUS LIFESCIENCES LIMITED et al.	Pending	2026-06-05	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
BIOMARIN PHARMACEUTICAL INC. v. ZYDUS LIFESCIENCES LIMITED et al 1:2026cv01005 3 patentsANDA 220670vosoritide	D.N.J.	2026-02-02	Active	—
Ascendis Pharma A/S et al v. Biomarin Pharmaceutical Inc. 4:2025cv05696 navepegritide (TransCon CNP - C-type natriuretic peptide variant)	CAND	2025-07-07	Terminated 2025-09-09	—
Ascendis Pharma A/S et al v. BioMarin Pharmaceutical Inc. 4:2025cv03302 1 patentnavepegritide (C-type natriuretic peptide / CNP)	CAND	2025-04-11	Terminated 2025-07-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)VOSORITIDE

DMF 420842025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 5, 2024	SUPPL -4	View Letter (PDF)
Oct 24, 2023	SUPPL -2	View Letter (PDF)
Nov 23, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.4MG/VIAL

RLD

8 patents4 exclusivities▴

POWDER;SUBCUTANEOUS | Approved: Nov 19, 2021

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE48267	May 20, 2030	—	—	—		—
8198242	Jun 11, 2035	—	Yes	Yes		—
9907834	Aug 1, 2036	—	—	Yes	—	—
10646550	Aug 1, 2036	—	—	Yes		—
11590204	Aug 1, 2036	—	—	Yes		—
11911446	Aug 1, 2036	—	—	—		—
12233106	Jul 11, 2042	—	—	—		—
12514906	Aug 1, 2036	—	—	Yes		—

Exclusivities (4)

Code	Date	Status
NCE	Nov 19, 2026	< 1 year
NPP	Oct 20, 2026	< 1 year
ODE-387	Nov 19, 2028	Active
ODE-449	Oct 20, 2030	Active

#002 — 0.56MG/VIAL

RLD

8 patents4 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Nov 19, 2021

#003 — 1.2MG/VIAL

RLD

8 patents4 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Nov 19, 2021