TASIMELTEON | N205677 | VANDA PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-10-01 | Terminated 2022-12-14 | — | |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 2 patentsANDA 211601tasimelteon | D. Del. | 2020-08-21 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc. et al 1 patentANDA 211654tasimelteon | D. Del. | 2020-03-03 | Terminated 2022-01-19 | — |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2020-01-22 | Terminated 2022-12-14 | — |
| D. Del. | 2020-01-21 | Terminated 2022-12-14 | — | |
| D. Del. | 2019-12-30 | Terminated 2022-12-14 | — | |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2019-11-26 | Terminated 2022-12-14 | — |
| D. Del. | 2019-04-12 | Terminated 2022-12-14 | — | |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 1 patentANDA 211601tasimelteon | D. Del. | 2019-03-22 | Terminated 2022-12-14 | — |
Vanda Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc. et al 7 patentsANDA 211654tasimelteon | D. Del. | 2018-05-07 | Terminated 2022-01-19 | — |
| D. Del. | 2018-05-07 | Terminated 2022-12-14 | — | |
Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. 6 patentsANDA 211601tasimelteon | D. Del. | 2018-04-30 | Terminated 2022-12-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from McDermott Will & Emery (on behalf of Vanda Pharmaceutic... FDA-2023-P-1388 Vanda Pharmaceuticals Inc., through counsel at McDermott Will & Emery, filed this citizen petition under 21 U.S.C. § 355(j) requesting that FDA revoke approval of ANDA No. 211601 submitted by Teva Pharmaceuticals USA, Inc. for 20 mg tasimelteon capsules and order a recall of the product, arguing tha | 505(q) | 2023-04-11 | Open | McDermott Will & Emery (on behalf of Vanda Pharmaceuticals Inc.) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE46604 | Jan 25, 2033 | — | — | — | — | |
| 9060995 | Jan 25, 2033 | — | — | — | — | |
| 9539234 | Jan 25, 2033 | — | — | — | — | |
| 9549913 | Jan 25, 2033 | — | — | — | — | |
| 9730910 | May 17, 2034 | — | — | — | — | |
| 9855241 | Jan 25, 2033 | — | — | — | — | |
| 10071977 | Feb 12, 2035 | — | Yes | Yes | — | — |
| 10149829 | Jan 25, 2033 | — | — | — | — | |
| 10179119 | Aug 29, 2035 | — | — | — | — | |
| 10376487 | Jul 27, 2035 | — | — | — | — | |
| 10449176 | Jan 25, 2033 | — | — | — | — | |
| 10610510 | Jan 25, 2033 | — | — | — | — | |
| 10610511 | Oct 10, 2034 | — | — | — | — | |
| 10829465 | Feb 12, 2035 | — | Yes | Yes | — | — |
| 10945988 | Jan 25, 2033 | — | — | — | — | |
| 10980770 | Jan 25, 2033 | — | — | — | — | |
| 11141400 | Oct 10, 2034 | — | — | — | — | |
| 11266622 | Aug 29, 2035 | — | — | — | — | |
| 11285129 | Jan 25, 2033 | — | — | — | — | |
| 11566011 | Feb 12, 2035 | — | Yes | Yes | — | — |
| 11633377 | Jan 25, 2033 | — | — | — | — | |
| 11759446 | Feb 21, 2041 | — | — | — | — | |
| 11760740 | Feb 12, 2035 | — | Yes | Yes | — | — |
| 11786502 | Oct 10, 2034 | — | — | — | — | |
| 11826339 | Jan 25, 2033 | — | — | — | — | |
| 11833130 | Jan 25, 2033 | — | — | — | — | |
| 11850229 | Jan 25, 2033 | — | — | — | — | |
| 11918556 | Apr 7, 2033 | — | — | — | — | |
| 11918557 | Jan 25, 2033 | — | — | — | — | |
| 12049457 | Feb 12, 2035 | — | Yes | Yes | — | — |
| 12201604 | Jan 25, 2033 | — | — | — | — |
| Code | Date | Status |
|---|---|---|
| ODE-330 | Dec 1, 2027 | Active |