abaloparatide · Radius · NDA 208743
Tymlos
Earliest generic entry, as listed
10 Jan 2040
Blocked by patent: US 11255842, US 11680942. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
12 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11255842 | use U-3322 · sets the listed date | 10 Jan 2040 |
| US 11680942 | use U-3322 · sets the listed date | 10 Jan 2040 |
| US 10996208 | drug product | 30 Apr 2038 |
| US 11782041 | drug product, use U-2009, U-3543 | 30 Apr 2038 |
| US 11782041 listing row | drug product, use U-2009 | 30 Apr 2038 |
| US 11782041 listing row | drug product, use U-3543 | 30 Apr 2038 |
| US 11977067 | drug product | 30 Apr 2038 |
| US 7803770 | use U-2009 | 28 Apr 2031 |
| US RE49444 | use U-2009, U-3543 | 28 Apr 2031 |
| US RE49444 listing row | use U-2009 | 28 Apr 2031 |
| US RE49444 listing row | use U-3543 | 28 Apr 2031 |
| US 8148333 | drug product | 8 Nov 2027 |
| US 8748382 | use U-2009, U-3543 | 3 Oct 2027 |
| US 8748382 listing row | use U-2009 | 3 Oct 2027 |
| US 8748382 listing row | use U-3543 | 3 Oct 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208743 · 001 · RLD | solution, subcutaneous | 3.12MG/1.56ML (2MG/ML) | 10 Jan 2040 |