remdesivir · Gilead Sciences Inc · NDA 214787
Veklury
Earliest generic entry, as listed
28 Nov 2041
Blocked by patent: US 11491169 (pediatric extension), US 11903953 (pediatric extension), US 11975012 (pediatric extension).
Listed patents · 16 unexpired
51 Orange Book listing rows for 16 patents, including 16 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11491169 | use U-3833, U-3834, U-3835, U-3836 | 28 Nov 2041 |
| US 11491169 listing row | use U-3833 | 28 May 2041 |
| US 11491169 listing row | use U-3834 | 28 May 2041 |
| US 11491169 listing row | use U-3835 | 28 May 2041 |
| US 11491169 listing row | use U-3836 | 28 May 2041 |
| US 11491169 listing row | pediatric extension · sets the listed date | 28 Nov 2041 |
| US 11903953 | use U-3833, U-3834, U-3835, U-3836 | 28 Nov 2041 |
| US 11903953 listing row | use U-3833 | 28 May 2041 |
| US 11903953 listing row | use U-3834 | 28 May 2041 |
| US 11903953 listing row | use U-3835 | 28 May 2041 |
| US 11903953 listing row | use U-3836 | 28 May 2041 |
| US 11903953 listing row | pediatric extension · sets the listed date | 28 Nov 2041 |
| US 11975012 | use U-3833, U-3834, U-3835, U-3836 | 28 Nov 2041 |
| US 11975012 listing row | use U-3833 | 28 May 2041 |
| US 11975012 listing row | use U-3834 | 28 May 2041 |
| US 11975012 listing row | use U-3835 | 28 May 2041 |
| US 11975012 listing row | use U-3836 | 28 May 2041 |
| US 11975012 listing row | pediatric extension · sets the listed date | 28 Nov 2041 |
| US 10675296 | drug product | 10 Jan 2039 |
| US 10675296 listing row | drug product | 10 Jul 2038 |
| US 10675296 listing row | pediatric extension | 10 Jan 2039 |
| US 11266681 | use U-3831, U-3832 | 10 Jan 2039 |
| US 11266681 listing row | use U-3831 | 10 Jul 2038 |
| US 11266681 listing row | use U-3832 | 10 Jul 2038 |
| US 11266681 listing row | pediatric extension | 10 Jan 2039 |
| US 11975017 | drug product | 10 Jan 2039 |
| US 11975017 listing row | drug product | 10 Jul 2038 |
| US 11975017 listing row | pediatric extension | 10 Jan 2039 |
| US 10695361 | use U-3829, U-3830, U-3831, U-3832 | 16 Mar 2037 |
| US 10695361 listing row | use U-3829 | 16 Sep 2036 |
| US 10695361 listing row | use U-3830 | 16 Sep 2036 |
| US 10695361 listing row | use U-3831 | 16 Sep 2036 |
| US 10695361 listing row | use U-3832 | 16 Sep 2036 |
| US 10695361 listing row | pediatric extension | 16 Mar 2037 |
| US 11007208 | use U-3829, U-3830, U-3831, U-3832 | 16 Mar 2037 |
| US 11007208 listing row | use U-3829 | 16 Sep 2036 |
| US 11007208 listing row | use U-3830 | 16 Sep 2036 |
| US 11007208 listing row | use U-3831 | 16 Sep 2036 |
| US 11007208 listing row | use U-3832 | 16 Sep 2036 |
| US 11007208 listing row | pediatric extension | 16 Mar 2037 |
| US 11382926 | use U-3829, U-3830, U-3831, U-3832 | 16 Mar 2037 |
| US 11382926 listing row | use U-3829 | 16 Sep 2036 |
| US 11382926 listing row | use U-3830 | 16 Sep 2036 |
| US 11382926 listing row | use U-3831 | 16 Sep 2036 |
| US 11382926 listing row | use U-3832 | 16 Sep 2036 |
| US 11382926 listing row | pediatric extension | 16 Mar 2037 |
| US 9724360 | drug substance, drug product | 29 Apr 2036 |
| US 9724360 listing row | drug substance, drug product | 29 Oct 2035 |
| US 9724360 listing row | pediatric extension | 29 Apr 2036 |
| US 9949994 | drug substance | 29 Apr 2036 |
| US 9949994 listing row | drug substance | 29 Oct 2035 |
| US 9949994 listing row | pediatric extension | 29 Apr 2036 |
| US 10065958 | drug substance | 18 May 2033 |
| US 10065958 listing row | drug substance | 18 Nov 2032 |
| US 10065958 listing row | pediatric extension | 18 May 2033 |
| US 11492353 | drug substance | 8 Jun 2032 |
| US 11492353 listing row | drug substance | 8 Dec 2031 |
| US 11492353 listing row | pediatric extension | 8 Jun 2032 |
| US 8008264 | drug substance, drug product | 6 Mar 2030 |
| US 8008264 listing row | drug substance, drug product | 6 Sep 2029 |
| US 8008264 listing row | pediatric extension | 6 Mar 2030 |
| US 8318682 | drug substance, drug product | 22 Oct 2029 |
| US 8318682 listing row | drug substance, drug product | 22 Apr 2029 |
| US 8318682 listing row | pediatric extension | 22 Oct 2029 |
| US RE46762 | drug substance, drug product | 22 Oct 2029 |
| US RE46762 listing row | drug substance, drug product | 22 Apr 2029 |
| US RE46762 listing row | pediatric extension | 22 Oct 2029 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 28 Aug 2027 |
| NPP | new patient population | 28 Feb 2027 |
| PED | pediatric (6 months added) | 13 Jan 2027 |
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
- Exclusivity expires within 90 days PED · 214787-002Exclusivity expires 13 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 214787-001Exclusivity expires 13 Jan 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214787 · 001 · RLD | powder, intravenous | 100MG/VIAL | 28 Nov 2041 |
| 214787 · 002 · RLD · discontinued | solution, intravenous | 100MG/20ML (5MG/ML) | 28 Nov 2041 |
Expired or delisted (3)
- M-301 · 13 Jul 2026
- PED · 22 Apr 2026
- NCE · 22 Oct 2025