Drug profile
Apalutamide
GenericRadar assessment
Patent Radar Assessment
Grade A1
United States · 2030 Radar
Verification
HIGH
Why Grade A?
J&J identifies ERLEADA U.S. composition-of-matter patent expiry year as 2030; US8445507 is listed as a Drug Substance patent and expires 2030-09-15.
Core Patent Expiry
2030-09-15
2030 Target Event
US8445507
Composition of Matter / Drug Substance · 2030-09-15
Core API Event?
Yes
Later Blocking Patents
Yes. J&J lists additional Orange Book patents extending through 2033, 2035, 2038 and 2040.
Generic Entry Assessment
High-priority 2030 core-patent event, but generic entry in 2030 is not automatic because later patents and any PTE/litigation must be reviewed.
Patent landscape
| Country | Patent no. | Type | Expiry | Status | Verified | Opportunity |
|---|---|---|---|---|---|---|
| United States | US8445507 | Composition of Matter / Drug Substance | 2030-09-15 | Protected | Yes | 60 |
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 |
|---|---|---|---|---|---|---|---|---|
| Apalutamide | Dr. Reddy's Laboratories | India | ✓ Listed | Not verified | Not verified | Not verified | Not verified | Available / US DMF |
| Apalutamide | Hetero Labs | India | ✓ Listed | Not verified | Not verified | Not verified | Not verified | US DMF listed |
| Apalutamide | Laurus Labs | India | Not verified | Not verified | Not verified | Not verified | Not verified | Commercial supplier / verify filing |