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YORVIPATH

NDA

PALOPEGTERIPARATIDE | N216490 | ASCENDIS PHARMA BONE DISEASES AS

3 strengths9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 2 exclusivities by expiration date

Active (9)TodayExclusivity

2026

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Today

Apr. 30, 2031

Sep. 28, 2037

Sep. 28, 2037

Sep. 28, 2037

Sep. 28, 2037

Sep. 28, 2037

Sep. 28, 2037

Nov. 12, 2042

Sep. 28, 2037

NCE

Aug. 9, 2029

ODE-492

Aug. 9, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 20, 2025	SUPPL -5	View Letter (PDF)
Aug 12, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)

RLD

9 patents2 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Aug 9, 2024

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8906847	Apr 30, 2031	—	Yes	Yes		—
11590207	Sep 28, 2037	—	—	—		—
11759504	Sep 28, 2037	—	—	Yes	—	—
11857603	Sep 28, 2037	—	—	—		—
11890326	Sep 28, 2037	—	Yes	Yes	—	—
11918628	Sep 28, 2037	—	Yes	Yes	—	—
12295989	Sep 28, 2037	—	—	—		—
12403182	Nov 12, 2042	—	—	Yes		—
12453778	Sep 28, 2037	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Aug 9, 2029	Active
ODE-492	Aug 9, 2031	Active

#002 — EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)

RLD

9 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Aug 9, 2024

#003 — EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML)

RLD

9 patents2 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Aug 9, 2024

Change History (2)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Palopegteriparatide (Yorvipath) received designation as a restricted distribution program product under NDA 216490, supplement 003.

Old: No

New: Yes

MODIFIEDrs7/1/2026

Palopegteriparatide (Yorvipath) received rare disease designation status under NDA 216490, supplement 002.

Old: No

New: Yes