Drug profile
Dabrafenib
GenericRadar assessment
Patent Radar Assessment
Grade A2
United States · 2030 Radar
Verification
HIGH
Why Grade A?
FDA 2026 Orange Book lists multiple TAFINLAR patents in 2030 with DS/DP flags, including US7994185 and US8415345 (2030-01-20) and US8703781 (2030-10-15).
Core Patent Expiry
2030-01-20
2030 Target Event
US7994185
Drug Substance / Drug Product · 2030-01-20
Core API Event?
Yes
Later Blocking Patents
Yes. TAFINLAR also has later method-of-use protection, including a 2033 patent event; pediatric extensions shift some 2030 dates by six months.
Generic Entry Assessment
Strong 2030 Drug Substance radar candidate. Generic-launch timing requires review of pediatric extensions, indication-specific patents and trametinib combination landscape.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US7994185 | Drug Substance / Drug Product | 2030-01-20 | Protected | Yes | 70 |
API sourcing
Regulatory filing labels distinguish verified/listed records from records that have not yet been verified. “Not verified” does not mean that a filing does not exist.
| API | Manufacturer | Country | US DMF | KDMF | Japan MF | CEP | EU GMP | Status |
|---|---|---|---|---|---|---|---|---|
| Dabrafenib mesylate | Guangdong Raffles Pharmatech Co Ltd | China | ✓ Listed | Not verified | Not verified | Not verified | Not verified | Active DMF |
| Dabrafenib mesylate | Valary Lab Private Limited | India | ✓ Listed | Not verified | Not verified | Not verified | ✓ Listed | Active DMF / GMP record |
| Dabrafenib mesylate | Viyash Scientific Ltd | India | ✓ Listed | Not verified | Not verified | Not verified | ✓ Listed | Active DMF / GMP record |
| Dabrafenib mesylate | Zhejiang Ausun Pharmaceutical Co., Ltd. | China | ✓ Listed | Not verified | Not verified | Not verified | ✓ Listed | Active DMF / GMP record |