TASIMELTEON | N205677 | VANDA PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Vanda Pharmaceuticals Inc. v. Aurobindo Pharma Limited et al 9 patentsANDA 221356tasimelteon | D. Del. | 2026-05-14 | Active | — |
| D. Del. | 2024-12-09 | Active | — | |
| D. Del. | 2024-12-09 | Active | — | |
| D. Del. | 2024-07-12 | Active | — | |
| D.N.J. | 2022-12-27 | Terminated 2023-02-10 | — | |
| D. Del. | 2021-02-24 | Terminated 2022-01-19 | — | |
| D. Del. | 2021-02-24 | Terminated 2022-12-14 | — | |
| D. Del. | 2020-10-01 | Terminated 2022-01-19 | — | |
| 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 | — |
| D. Del. | 2020-02-19 | 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. | 2019-05-17 | Terminated 2022-01-19 | — | |
| 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 LLP FDA-2023-P-1985 · 15 docket documents McDermott Will & Emery LLP, on behalf of Vanda Pharmaceuticals Inc., filed this citizen petition requesting that FDA revoke approval of ANDA No. 211654 submitted by MSN Pharmaceuticals Inc. for 20 mg tasimelteon capsules and order a recall of any distributed product because MSN's bioequivalence stud | 505(q) | 2023-05-17 | Denied | McDermott Will & Emery LLP |
Citizen Petition from McDermott Will & Emery (on behalf of Vanda Pharmaceutic... FDA-2023-P-1388 · 17 docket documents 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 | Denied | Vanda Pharmaceuticals Inc. |
Citizen Petition from McDermott Will & Emery, LLP FDA-2023-P-0344 · 8 docket documents Vanda Pharmaceuticals Inc. filed this citizen petition on January 27, 2023, requesting that the FDA revoke approval of ANDA No. 211607 submitted by Apotex Inc. and Apotex Corp for 20 mg tasimelteon capsules, contending that Apotex's label fails to satisfy the FDCA's "same labeling" and "same conditi | 505(q) | 2023-01-30 | Denied | McDermott Will & Emery, LLP |
Citizen Petition from McDermott Will & Emery, LLP FDA-2023-P-0313 · 33 docket documents Vanda Pharmaceuticals Inc. filed this petition through counsel at McDermott Will & Emery LLP requesting that the FDA revoke approval of ANDA No. 211601 for Teva Pharmaceuticals USA Inc.'s 20 mg tasimelteon capsules and order its recall, arguing that Teva's product labeling fails to comply with the r | 505(q) | 2023-01-26 | Denied | McDermott Will & Emery, LLP |
Citizen Petition from Public Citizen FDA-2015-P-2142 · 6 docket documents Public Citizen filed this citizen petition on June 11, 2015, requesting that the FDA revise the indication for tasimelteon (Hetlioz) to limit it to blind patients without light perception as originally approved in NDA 205677, require revisions to safety labeling sections including carcinogenesis and | Other | 2015-06-15 | Denied | Public Citizen |
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 |