Prescription medicine

Abaloparatide Brand names: Tymlos

Abaloparatide (Tymlos) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the abaloparatide FDA label on DailyMed (effective August 11, 2026, Radius Health, Inc.); the NDA 208743 record on Drugs@FDA; every abaloparatide label on DailyMed.

Highlights of the record

FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.

Forms and strengths

3.12 mg/1.56ml

Injection (solution).

On the market

Earliest approval on file: April 28, 2017 Tymlos, Radius; Drugs@FDA’s file, where older or withdrawn approvals can be missing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: January 10, 2040 Tymlos 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: 29,258 through July 30, 2026

What is abaloparatide used for?

From the label: indications and usage
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1.1 ) Treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. […]

Conditions named in the indications of abaloparatide's FDA labels, with every medicine labeled for each:

Osteoporosis

FDA pharmacologic class: Parathyroid Hormone-Related Peptide Analog.

Source: FDA drug label (Tymlos), Radius Health, Inc., effective August 11, 2026 (SPL set 712143d9-e21e-4013-bb3b-3426a21060a8), via openFDA; the full label on DailyMed

What does the patient leaflet for abaloparatide 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 TYMLOS?
TYMLOS may cause serious side effects including: Allergic (hypersensitivity) reactions, including anaphylaxis. Stop taking TYMLOS 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 Possible bone cancer (osteosarcoma). During animal drug testing, the medicine in TYMLOS caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take TYMLOS will have a higher chance of getting osteosarcoma. Tell your healthcare provider right away if you have pain in your bones, 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.

From the patient leaflet: How should I store TYMLOS?
Before first use, store TYMLOS pens in the refrigerator between 36°F to 46°F (2°C to 8°C). After first use, store your TYMLOS pen for up to 30 days at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze the TYMLOS pen or expose it to heat. Do not use TYMLOS after the expiration date printed on the pen and packaging. Throw away the TYMLOS pen after 30 days even if some medicine is left in the pen (see " Instructions for Use "). Keep TYMLOS and all medicines out of the reach of children.

Source: FDA drug label (Tymlos), Radius Health, Inc., effective August 11, 2026 (SPL set 712143d9-e21e-4013-bb3b-3426a21060a8), via openFDA; the full label on DailyMed

Is there a generic for abaloparatide (Tymlos)?

No generic abaloparatide is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 9 patents for Tymlos injection, the last expiring on January 10, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2017 earliest approval on file
2040 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for abaloparatide?

The FDA Adverse Event Reporting System holds 29,258 reports that list abaloparatide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 313 are coded as a death and 2,046 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. Reports rose sharply in 2025 (6,306, against a median of 2,039 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.

Reports received each year

The most reported reactions

Headache (named in the label)5,123
Nausea (named in the label)3,913
Dizziness (named in the label)3,860
Fatigue (named in the label)3,419
Product Dose Omission Issue (a use or a product term, not a reaction)2,654
Heart Rate Increased2,593
Arthralgia (named in the label)2,343
Palpitations (named in the label)2,225

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as abaloparatide?

2 other medicines are given the same way (subcutaneous) and in the same FDA class as abaloparatide or labeled mainly for the same use (osteoporosis), the same class first. Osteoporosis lists all 16 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (subcutaneous)	Pharmacy cost	Shortage
Denosumab	Osteoporosis	none listed	$1,862.74 per mL 60 mg/mL syringe	No current entry
Teriparatide	Osteoporosis	4 labelers	$479.95 per mL 560 mcg/2.24 mL pen	No current entry

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Abaloparatide side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other