Home / Generic availability / Teriparatide
When will generic Teriparatide be available?
The FDA lists no patents or exclusivity for teriparatide, and 3 generic applications are already approved, so generic teriparatide is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| PARATHAR | Brand (NDA) | SANOFI AVENTIS US LLC | 1987-12-23 | |
| FORTEO | Brand (NDA) | ELI LILLY AND CO | 2002-11-26 | reference listed drug, reference standard |
| TERIPARATIDE | Generic (ANDA) | TEVA PHARMACEUTICALS USA INC | 2023-11-16 | |
| TERIPARATIDE | Generic (ANDA) | APOTEX INC | 2023-11-16 | |
| BONSITY | Brand (NDA) | ALVOGEN INC | 2019-10-04 | |
| TERIPARATIDE | Generic (ANDA) | AMPHASTAR PHARMACEUTICALS INC | 2025-12-12 | |
| TERIPARATIDE | Brand (NDA) | ALMAJECT INC | 2024-06-04 | reference listed drug, reference standard |
What a generic Teriparatide would have to match
Forms and strengths
Injection: 560 mcg/2.24 mL (250 mcg/mL) clear, colorless solution in a single-patient-use prefilled delivery device (pen) intended to deliver 28 daily doses of 20 mcg. Injection: 560 mcg/2.24 mL (250 mcg/mL) in a single-patient-use prefilled delivery device (pen) intended to deliver 28 daily doses of 20 mcg ( 3 )
How it is supplied
16.1 How Supplied FORTEO (teriparatide injection) is a clear and colorless solution, available as single-patient-use prefilled delivery device (pen) in the following package size: 560 mcg/2.24 mL (250 mcg/mL) [intended to deliver 28 daily doses of 20 mcg] NDC 0002-9678-01 (MS8400). 16.2 Storage and Handling Store FORTEO under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light. When using FORTEO, minimize the time out of the refrigerator; deliver the dose immediately following removal from the refrigerator. Do not freeze. Do not use FORTEO if it has...
Storage
Store FORTEO under refrigeration at 2° to 8°C (36° to 46°F) at all times except when administering the product. Recap the delivery device (pen) when not in use to protect the cartridge from physical damage and light. When using FORTEO, minimize the time out of the refrigerator; deliver the dose immediately following removal from the refrigerator. Do not freeze. Do not use FORTEO if it has been frozen. Throw away the device 28 days after first use.
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 2026-08-03.
Recalls involving Teriparatide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| TMC Acquisition LLC dba Tailor Made Compounding | KY | Class II | 2022-03-07 | Lack of Assurance of Sterility |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Ziconotideno patent or exclusivity listed
- Romidepsinprotection runs to December 2026
- Pasireotideprotection runs to December 2026
- Leuprolideprotection runs to January 2027
- Carfilzomibprotection runs to January 2027
Frequently asked questions
When will generic Teriparatide be available?
The FDA lists no patents or exclusivity for teriparatide, and 3 generic applications are already approved, so generic teriparatide is available in the United States.
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
- Teriparatide 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