Prescription medicine
Palopegteriparatide Brand names: Yorvipath
Palopegteriparatide (Yorvipath) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the palopegteriparatide FDA label on DailyMed (effective August 12, 2026, Ascendis Pharma, Endocrinology, Inc.); the NDA 216490 record on Drugs@FDA; every palopegteriparatide label on DailyMed.
Highlights of the record
FDA label of August 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageYORVIPATH is indicated for the treatment of hypoparathyroidism in adults.
Forms and strengths
- 0.56ml
- 0.98ml
- 1.4ml
Injection (solution).
On the market
- Earliest approval on file
- August 9, 2024 Yorvipath, Ascendis Pharma Bone; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 12, 2042 Yorvipath injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 368 through July 30, 2026
What is palopegteriparatide used for?
From the label: indications and usageYORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. ( 1 ) Limitations of Use: Not studied for acute post-surgical hypoparathyroidism. ( 1 ) Titration scheme only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. ( 1 ) Limitations of Use YORVIPATH was not studied for acute post-surgical hypoparathyroidism. […]
FDA pharmacologic class: Parathyroid Hormone Analog.
Source: FDA drug label (Yorvipath), Ascendis Pharma, Endocrinology, Inc., effective August 12, 2026 (SPL set a1fa23fd-c434-443e-9a17-5750578c8602), via openFDA; the full label on DailyMed
What does the patient leaflet for palopegteriparatide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about YORVIPATH?YORVIPATH may cause serious side effects, including: Allergic (hypersensitivity) reactions, including anaphylaxis. Stop taking YORVIPATH and get medical help right away if you have any of the following symptoms of an allergic reaction: swelling of your face, lips, mouth, or tongue breathing problems fainting, dizziness, feeling lightheaded (low blood pressure) fast heartbeat itching rash hives High levels of calcium in the blood (hypercalcemia). YORVIPATH can cause some people to have higher blood calcium levels than normal. Your health care provider should check your blood calcium before you start and during your treatment with YORVIPATH. Tell your health care provider if you have nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness, and irregular heartbeat. Hypercalcemia is more likely to occur within the first 3 months of starting YORVIPATH, but it may occur at any time. Low levels of calcium in the blood (hypocalcemia). People who stop using, miss, or change a dose of YORVIPATH may have an increased risk of low blood calcium levels, but hypocalcemia may occur at any time. Tell your health care provider if you have tingling in your fingertips, toes, lips or tongue, muscle spasms or cramps, oral numbness, depression, have problems thinking or remembering, abnormal heart rhythms, and seizures. Possible bone cancer (osteosarcoma). Tell your health care provider right away if you have pain in any areas of your body that does not go away or any new or unusual lumps or swelling under your skin that is tender to touch. These are some of the signs and symptoms of osteosarcoma and your health care provider may need to do further tests. […]
From the patient leaflet: How should I store YORVIPATH?Before first use, store YORVIPATH in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze. Store away from heat. Store in the package with the pen cap on in order to protect from light. After first use, store at room temperature below 86°F (30°C). Keep the pen cap on the prefilled pen in order to protect from light. Throw away each pen 14 days after first use. Keep YORVIPATH and all medicines out of the reach of children.
Source: FDA drug label (Yorvipath), Ascendis Pharma, Endocrinology, Inc., effective August 12, 2026 (SPL set a1fa23fd-c434-443e-9a17-5750578c8602), via openFDA; the full label on DailyMed
Is there a generic for palopegteriparatide (Yorvipath)?
No generic palopegteriparatide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Yorvipath injection: the compound patent runs to September 28, 2037, and the last listed entry to November 12, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the palopegteriparatide label say about other medicines?
The palopegteriparatide label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | Affected by Serum Calcium Digoxin YORVIPATH increases serum calcium, therefore, concomitant use with digoxin (which has a narrow therapeutic index) may predispose patients to digitalis toxicity if hypercalcemia develops. |
| Teriparatide | warnings and precautions | An increased incidence of osteosarcoma (a malignant bone tumor) has been reported in male and female rats treated with PTH analogs, including teriparatide. |
Source: FDA drug label (Yorvipath), Ascendis Pharma, Endocrinology, Inc., effective August 12, 2026 (SPL set a1fa23fd-c434-443e-9a17-5750578c8602), via openFDA; the full label on DailyMed
What do FAERS reports show for palopegteriparatide?
The FDA Adverse Event Reporting System holds 368 reports that list palopegteriparatide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 90 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other parathyroid hormone analogs
- the pharmacologic class, with prices and generics
- Palopegteriparatide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other