MIFEPRISTONE | N202107 | CORCEPT THERAPEUTICS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| PGR2019-00048 | 10195214 | PGR | Teva Pharmaceuticals USA, Inc. | Final Written Decision | 2019-05-07 | — |
| IPR2018-01494 | 8921348 | IPR | Neptune Generics LLC | Final Written Decision | 2018-08-02 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC. 2 patentsANDA 211436mifepristone | D.N.J. | 2023-03-17 | Terminated 2023-05-15 | — |
CORCEPT THERAPEUTICS, INC. v. HIKMA PHARMACEUTICALS USA INC. 4 patentsANDA 215242mifepristone | D.N.J. | 2021-03-12 | Terminated 2022-12-09 | — |
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC. et al 1 patentANDA 211436mifepristone | D.N.J. | 2019-12-13 | Terminated 2020-03-27 | — |
CORCEPT THERAPEUTICS, INC. v. SUN PHARMA GLOBAL FZE et al 3 patentsANDA 213387mifepristone | D.N.J. | 2019-07-22 | Terminated 2021-06-17 | — |
CORCEPT THERAPEUTICS, INC. v. TEVA PHARMACEUTICALS USA, INC. et al 3 patentsANDA 211436mifepristone | D.N.J. | 2019-02-08 | Terminated 2019-02-21 | — |
| D.N.J. | 2018-03-15 | Terminated 2022-02-03 | Julien Xavier Neals |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nicholas W. Brown, Attorney General of Washington, et. al. FDA-2025-P-3287 · 57 docket documents Nicholas W. Brown, Attorney General of Washington, along with Attorneys General and officials from eighteen other states and the District of Columbia, filed this citizen petition requesting that the FDA remove the Mifepristone REMS Program entirely, or alternatively, exercise discretion to not enfor | Other | 2025-08-26 | Open | Nicholas W. Brown, Attorney General of Washington, et. al. |
Citizen Petition from American Association of Pro-Life Obstetricians and Gyne... FDA-2025-P-3288 · 16 docket documents The American Association of Pro-Life Obstetricians and Gynecologists and allied groups filed this citizen petition requesting that the FDA deny a supplemental new drug indication (NDI) application for mifepristone use in miscarriage management, citing insufficient real-world safety data on hemorrhag | 505(q) | 2025-08-22 | Denied | American Association of Pro-Life Obstetricians and Gynecologists, et al. |
Citizen Petition from American Association of Pro-Life Obstetricians and Gyne... FDA-2025-P-3130 · 16 docket documents The American Association of Pro-Life Obstetricians and Gynecologists and allied organizations filed this citizen petition on August 13, 2025, requesting that FDA deny a supplemental new drug indication (NDI) application for mifepristone in miscarriage management and requesting that FDA strengthen th | 505(q) | 2025-08-15 | Withdrawn | American Association of Pro-Life Obstetricians and Gynecologists, et al. |
Citizen Petition from Attorney General of Massachusetts, et al. FDA-2025-P-1576 · 23 docket documents The Commonwealth of Massachusetts, along with California, New Jersey, and New York, filed this citizen petition requesting that the FDA remove the Mifepristone REMS Program for Mifeprex and generic Mifepristone Tablets 200 mg, or alternatively, exercise enforcement discretion and not enforce the Pre | Other | 2025-06-06 | Open | Attorney General of Massachusetts, et al. |
Citizen Petition from James Brinkruff FDA-2025-P-1242 · 4 docket documents James Brinkruff MD filed this citizen petition requesting that the FDA immediately suspend approval of mifepristone (Mifeprex) pending a comprehensive safety review, citing a study identifying a serious adverse event rate exceeding 10% in real-world telehealth use conditions that diverge significant | Other | 2025-05-14 | Open | James Brinkruff |
Citizen Petition from American College of Obstetricians and Gynecologists FDA-2025-P-0377 · 10 docket documents The American College of Obstetricians and Gynecologists, Society of Family Planning, and Society for Maternal-Fetal Medicine filed this citizen petition requesting that FDA remove the Mifepristone Shared System Risk Evaluation and Mitigation Strategy (REMS) program, including all Elements to Assure | Other | 2025-02-04 | Open | American College of Obstetricians and Gynecologists |
Citizen Petition from American Association of Pro-Life Obstetricians and Gyne... FDA-2025-P-0102 · 3 docket documents The American Association of Pro-Life Obstetricians and Gynecologists filed this petition on December 20, 2024, refiled January 7, 2025, requesting that the FDA require additional safety studies under anticipated use conditions before approving mifepristone for miscarriage management, and if approved | 505(q) | 2025-01-10 | Denied | American Association of Pro-Life Obstetricians and Gynecologists |
Citizen Petition from Students for Life of America FDA-2024-P-5967 · 3 docket documents Students for Life of America filed this citizen petition under Section 505 of the Food Drug and Cosmetic Act, the Clean Water Act, and the Endangered Species Act, requesting that the FDA refrain from modifying the approved use of Mifepristone to include miscarriage care until the agency complies wit | 505(q) | 2025-01-02 | Denied | Students for Life of America |
Citizen Petition from Students for Life of America FDA-2024-P-5891 · 3 docket documents Students for Life of America filed this petition under Section 505 of the Food, Drug and Cosmetic Act and the Clean Water Act and Endangered Species Act, requesting that the FDA refrain from modifying the approved use of mifepristone to include miscarriage care until the agency complies with state w | Other | 2024-12-20 | Withdrawn | Students for Life of America |
Citizen Petition from American Association of Pro-Life Obstetricians and Gyne... FDA-2024-P-5892 · 3 docket documents The American Association of Pro-Life Obstetricians and Gynecologists and allied groups filed this citizen petition on December 20, 2024, requesting that FDA require additional safety studies before approving mifepristone for miscarriage management, and if approved, that FDA establish a Risk Evaluati | Other | 2024-12-20 | Withdrawn | American Association of Pro-Life Obstetricians and Gynecologists, et al. |
Citizen Petition from Students for Life of America FDA-2023-P-3328 · 6 docket documents Students for Life of America filed this citizen petition under 21 C.F.R. § 10.30 and Section 505 of the Food, Drug and Cosmetic Act, requesting that the FDA revoke its 2000 approval of the Population Council's new drug application for mifepristone (Mifeprex), the 2019 approval of GenBioPro's generic | Other | 2023-08-04 | Denied | Students for Life of America |
Citizen Petition from Students for Life of America FDA-2023-P-1528 · 6 docket documents Students for Life of America filed this citizen petition on April 19, 2023, requesting that the FDA revoke its approvals and modifications of mifepristone under section 505 of the Food, Drug and Cosmetic Act and section 7 of the Endangered Species Act, arguing that the FDA failed to consult with the | Other | 2023-04-19 | Denied | Students for Life of America |
Citizen Petition from Students for Life of America FDA-2022-P-3209 · 3 docket documents Students for Life of America filed this citizen petition under 21 C.F.R. § 10.30 and Section 505-1 of the Food Drug and Cosmetic Act requesting that the FDA reverse the 2016 and 2021 modifications to mifepristone's Risk Evaluation and Mitigation Strategy and restore the 2011 REMS, which would requir | Other | 2022-12-15 | Denied | Students for Life of America |
Citizen Petition from STUDENTS FOR LIFE OF AMERICA FDA-2022-P-2872 · 6 docket documents Students for Life of America filed this citizen petition on November 15, 2022, under 21 C.F.R. § 10.30 and Section 505-1 of the Food, Drug, and Cosmetic Act requesting that the FDA modify the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone to require prescribers to include a medical | Other | 2022-11-15 | Denied | STUDENTS FOR LIFE OF AMERICA |
Citizen Petition from the American College of Obstetrician and Gynecologists FDA-2022-P-2425 · 54 docket documents The American College of Obstetricians and Gynecologists filed this citizen petition on October 4, 2022, requesting that the FDA ask Danco Laboratories to submit a Supplemental New Drug Application to add miscarriage management as an indication to the mifepristone label and to eliminate or modify the | Other | 2022-10-06 | Denied | the American College of Obstetrician and Gynecologists |
Citizen Petition from American Association of Pro-Life Obstetricians and Gyne... FDA-2019-P-1534 · 15 docket documents The American Association of Pro-Life Obstetricians and Gynecologists and American College of Pediatricians filed this citizen petition on March 29, 2019, requesting that the FDA restore and strengthen elements of the original Mifeprex (mifepristone) regimen approved in 2000, including limiting use t | 505(q) | 2019-04-01 | Partially Denied | American Association of Pro-Life Obstetricians and Gynecologists and American College of Pediatricians |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8921348 | Aug 27, 2028 | — | — | — | — | |
| 9829495 | Aug 15, 2036 | — | — | — | — | |
| 9943526 | Apr 20, 2036 | — | — | — | — | |
| 10006924 | Aug 12, 2036 | — | — | — | — | |
| 10151763 | Jan 18, 2037 | — | — | — | — | |
| 10166242 | Apr 20, 2036 | — | — | — | — | |
| 10166243 | Apr 20, 2036 | — | — | — | — | |
| 10195214 | Jun 19, 2037 | — | — | — | — | |
| 10231983 | Aug 22, 2038 | — | — | — | — | |
| 10314850 | Aug 22, 2038 | — | — | — | — | |
| 10495650 | Aug 12, 2036 | — | — | — | — | |
| 10500216 | Mar 5, 2033 | — | — | — | — | |
| 10660904 | Apr 20, 2036 | — | — | — | — | |
| 10780097 | Aug 22, 2038 | — | — | — | — | |
| 10842800 | Jun 19, 2037 | — | — | — | — | |
| 10842801 | Nov 15, 2032 | — | — | — | — | |
| 11969435 | Jun 19, 2037 | — | — | — | — | |
| 12097210 | Jun 19, 2037 | — | — | — | — |