Drug

Teriparatide

As of the edition of 20 October 2026, Teriparatide is a protein: marketed, first approved in 1987 (US); acts on PTH1R; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2017
Kind
Protein
Brand name
Parathar
First approved
23 December 1987 (US)
Approvals on record
18 in 5 regions
Holder of the most recent approval
Apsen Farmaceutica; 12 holders in all
Withdrawn from market
24 November 2020 (in some regions)
Registered trials
112, 10 stopped early
Disease areas
Bones, joints and muscles; Nutrition and metabolism; Injuries; Hormones; Nervous system; Pregnancy and women's health

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

3 companies on route B because of this drug.

Companies on route B for this drug

In the product

3 companies are on route B because of Teriparatide.

Target

GeneProteinUniProt
PTH1RParathyroid hormone/parathyroid hormone-related peptide receptorQ03431

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated211262
Phase 112911
Phase 2251515
Phase 3242201
Phase 4302221
All trials112

Who has held its approvals

CompanyRoleYears
SanofiApplicant1987 to now
Eli LillyApplicant, Later holder and Lead sponsor of trials1996 to now
Asahi Kasei TherapeuticsApplicant2011 to now
Ligand PharmaceuticalsLater holder and Lead sponsor of trials2015 to now
AlvogenAcquired holder2020 to now
SUN Pharmaceutical IndustriesAcquired holder2022 to now
AlmajectLater holder2024 to now
Apsen FarmaceuticaApplicant2026 to now