Home / Generic availability / Abaloparatide
When will generic Abaloparatide be available?
Based on the patents and exclusivity the FDA lists today, generic abaloparatide cannot be marketed in the United States before 2040-01-10, when the last listed protection expires.
Patents listed with the FDA
9 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 8748382 | 2027-10-03 | method of use | TYMLOS |
| 8148333 | 2027-11-08 | drug product | TYMLOS |
| 7803770 | 2031-04-28 | method of use | TYMLOS |
| RE49444 | 2031-04-28 | method of use | TYMLOS |
| 10996208 | 2038-04-30 | drug product | TYMLOS |
| 11782041 | 2038-04-30 | drug product | TYMLOS |
| 11977067 | 2038-04-30 | drug product | TYMLOS |
| 11255842 | 2040-01-10 | method of use | TYMLOS |
| 11680942 | 2040-01-10 | method of use | TYMLOS |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| TYMLOS | Brand (NDA) | RADIUS HEALTH INC | 2017-04-28 | reference listed drug, reference standard |
What a generic Abaloparatide would have to match
Forms and strengths
Injection: 3120 mcg/1.56 mL (2000 mcg/mL) of abaloparatide in clear, colorless solution in a single-patient-use prefilled pen. The prefilled pen delivers 30 doses of TYMLOS, each containing 80 mcg of abaloparatide in 40 mcL. Injection: 3120 mcg/1.56 ml (2000 mcg/ml) of abaloparatide in clear, colorless solution in a single-patient-use prefilled pen. The prefilled pen delivers 30 daily doses of 80 mcg abaloparatide in 40 mcl. ( 3 )
How it is supplied
16.1 How Supplied TYMLOS (abaloparatide) injection is a clear and colorless solution, available as a pre-assembled single-patient-use disposable pen (NDC 70539-001-01) packaged in a cardboard carton (NDC 70539-001-02) with the Instructions for Use and Medication Guide. Each disposable pen embodies a glass cartridge that contains 3120 mcg of abaloparatide in 1.56 mL (2000 mcg/mL). Each pen provides a 30-day supply for once daily injection of 80 mcg abaloparatide in 40 mcL. Sterile needles are not included. 16.2 Storage and Handling Before first use, store TYMLOS under refrigeration between 2°C to 8°C (36°F to 46°F). After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do...
Storage
Before first use, store TYMLOS under refrigeration between 2°C to 8°C (36°F to 46°F). After first use, store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do not freeze or subject to heat.
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-08-11.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Macimorelinprotection runs to October 2027
- Setmelanotideprotection runs to October 2027
- Plecanatideprotection runs to January 2028
- Glucagonprotection runs to March 2028
- Bivalirudinprotection runs to July 2028
Frequently asked questions
When will generic Abaloparatide be available?
Based on the patents and exclusivity the FDA lists today, generic abaloparatide cannot be marketed in the United States before 2040-01-10, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
Related data
- Abaloparatide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book