sofosbuvir; velpatasvir; voxilaprevir · Gilead Sciences Inc · NDA 209195
Vosevi
Earliest generic entry, as listed
1 Dec 2037
Blocked by patent: US 11338007 (pediatric extension).
Listed patents · 18 unexpired
47 Orange Book listing rows for 18 patents, including 14 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11338007 | drug product, use U-2039, U-2040 | 1 Dec 2037 |
| US 11338007 listing row | drug product, use U-2039 | 1 Jun 2037 |
| US 11338007 listing row | drug product, use U-2040 | 1 Jun 2037 |
| US 11338007 listing row | pediatric extension · sets the listed date | 1 Dec 2037 |
| US 10912814 | drug product | 1 Jun 2037 |
| US 11116783 | drug product, use U-2039, U-2040 | 30 Jul 2034 |
| US 11116783 listing row | drug product, use U-2039 | 30 Jan 2034 |
| US 11116783 listing row | drug product, use U-2040 | 30 Jan 2034 |
| US 11116783 listing row | pediatric extension | 30 Jul 2034 |
| US 9296782 | drug substance, drug product | 17 Jul 2034 |
| US 8575135 | drug substance, drug product, use U-2039, U-2040 | 16 May 2033 |
| US 8575135 listing row | drug substance, drug product, use U-2039 | 16 Nov 2032 |
| US 8575135 listing row | drug substance, drug product, use U-2040 | 16 Nov 2032 |
| US 8575135 listing row | pediatric extension | 16 May 2033 |
| US 8921341 | drug substance, drug product, use U-2039, U-2040 | 16 May 2033 |
| US 8921341 listing row | drug substance, drug product, use U-2039 | 16 Nov 2032 |
| US 8921341 listing row | drug substance, drug product, use U-2040 | 16 Nov 2032 |
| US 8921341 listing row | pediatric extension | 16 May 2033 |
| US 8940718 | drug substance, drug product, use U-2039, U-2040 | 16 May 2033 |
| US 8940718 listing row | drug substance, drug product, use U-2039 | 16 Nov 2032 |
| US 8940718 listing row | drug substance, drug product, use U-2040 | 16 Nov 2032 |
| US 8940718 listing row | pediatric extension | 16 May 2033 |
| US 9868745 | drug substance, drug product | 16 Nov 2032 |
| US 8618076 | drug substance, drug product, use U-2039, U-2040 | 11 Jun 2031 |
| US 8618076 listing row | drug substance, drug product, use U-2039 | 11 Dec 2030 |
| US 8618076 listing row | drug substance, drug product, use U-2040 | 11 Dec 2030 |
| US 8618076 listing row | pediatric extension | 11 Jun 2031 |
| US 9284342 | drug substance, drug product, use U-2039, U-2040 | 13 Mar 2031 |
| US 9284342 listing row | drug substance, drug product, use U-2039 | 13 Sep 2030 |
| US 9284342 listing row | drug substance, drug product, use U-2040 | 13 Sep 2030 |
| US 9284342 listing row | pediatric extension | 13 Mar 2031 |
| US 7964580 | drug substance, drug product, use U-2039, U-2040 | 26 Sep 2029 |
| US 7964580 listing row | drug substance, drug product, use U-2039 | 26 Mar 2029 |
| US 7964580 listing row | drug substance, drug product, use U-2040 | 26 Mar 2029 |
| US 7964580 listing row | pediatric extension | 26 Sep 2029 |
| US 8633309 | drug substance, drug product, use U-2039, U-2040 | 26 Sep 2029 |
| US 8633309 listing row | drug substance, drug product, use U-2039 | 26 Mar 2029 |
| US 8633309 listing row | drug substance, drug product, use U-2040 | 26 Mar 2029 |
| US 8633309 listing row | pediatric extension | 26 Sep 2029 |
| US 8889159 | drug substance, drug product, use U-2039, U-2040 | 26 Sep 2029 |
| US 8889159 listing row | drug substance, drug product, use U-2039 | 26 Mar 2029 |
| US 8889159 listing row | drug substance, drug product, use U-2040 | 26 Mar 2029 |
| US 8889159 listing row | pediatric extension | 26 Sep 2029 |
| US 8334270 | drug substance, drug product, use U-2039, U-2040 | 21 Sep 2028 |
| US 8334270 listing row | drug substance, drug product, use U-2039 | 21 Mar 2028 |
| US 8334270 listing row | drug substance, drug product, use U-2040 | 21 Mar 2028 |
| US 8334270 listing row | pediatric extension | 21 Sep 2028 |
| US 8580765 | drug substance, drug product, use U-2039, U-2040 | 21 Sep 2028 |
| US 8580765 listing row | drug substance, drug product, use U-2039 | 21 Mar 2028 |
| US 8580765 listing row | drug substance, drug product, use U-2040 | 21 Mar 2028 |
| US 8580765 listing row | pediatric extension | 21 Sep 2028 |
| US 8735372 | drug substance, drug product, use U-2039, U-2040 | 21 Sep 2028 |
| US 8735372 listing row | drug substance, drug product, use U-2039 | 21 Mar 2028 |
| US 8735372 listing row | drug substance, drug product, use U-2040 | 21 Mar 2028 |
| US 8735372 listing row | pediatric extension | 21 Sep 2028 |
| US 9085573 | drug substance, drug product, use U-2039, U-2040 | 21 Sep 2028 |
| US 9085573 listing row | drug substance, drug product, use U-2039 | 21 Mar 2028 |
| US 9085573 listing row | drug substance, drug product, use U-2040 | 21 Mar 2028 |
| US 9085573 listing row | pediatric extension | 21 Sep 2028 |
| US 8957046 | use U-2039, U-2040 | 21 Mar 2028 |
| US 8957046 listing row | use U-2039 | 21 Mar 2028 |
| US 8957046 listing row | use U-2040 | 21 Mar 2028 |
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 |
|---|---|---|---|
| 209195 · 001 · RLD | tablet, oral | 400MG;100MG;100MG | 1 Dec 2037 |