bosentan · Actelion · NDA 021290, 209279
Tracleer
2 of 3 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 7959945.
FDA has approved 1 generic application (ANDA) for Tracleer, though its earliest generic-entry date is 28 Dec 2027 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7959945 | product | 28 Dec 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
- 25 Oct 2026Generic approved · 209279-00117 Feb 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021290 · 001 · RLD | tablet, oral | 62.5MG | open |
| 021290 · 002 · RLD | tablet, oral | 125MG | open |
| 209279 · 001 · RLD | tablet, for suspension, oral | 32MG | 28 Dec 2027 |
Expired or delisted (1)
- US 8309126 · product · 15 May 2026