FDA Orange Book
Is there a generic for Tymlos?
Tymlos contains abaloparatide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tymlos (abaloparatide). The Orange Book shows its last listed patent expires January 10, 2040.
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Tymlos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 3.12MG/1.56ML (2MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 208743, held by RADIUS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tymlos patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8748382 | October 3, 2027 | Method of use | U-3543 | 208743 |
| 8748382 | October 3, 2027 | Method of use | U-2009 | 208743 |
| 8148333 | November 8, 2027 | Drug product | None | 208743 |
| 7803770 | April 28, 2031 | Method of use | U-2009 | 208743 |
| RE49444 | April 28, 2031 | Method of use | U-2009 | 208743 |
| RE49444 | April 28, 2031 | Method of use | U-3543 | 208743 |
| 11782041 | April 30, 2038 | Drug product | U-2009 | 208743 |
| 11782041 | April 30, 2038 | Drug product | U-3543 | 208743 |
| 11977067 | April 30, 2038 | Drug product | None | 208743 |
| 10996208 | April 30, 2038 | Drug product | None | 208743 |
| 11680942 | January 10, 2040 | Method of use | U-3322 | 208743 |
| 11255842 | January 10, 2040 | Method of use | U-3322 | 208743 |
Tymlos NDC codes
Questions
Is there a generic for Tymlos?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tymlos (abaloparatide). The Orange Book shows its last listed patent expires January 10, 2040.
What is the generic name for Tymlos?
The active ingredient in Tymlos is abaloparatide, per the FDA Orange Book.
When does the Tymlos patent expire?
The last patent listed for Tymlos in the Orange Book expires January 10, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.