MIFEPRISTONE Drug Patent Profile
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When do Mifepristone patents expire, and when can generic versions of Mifepristone launch?
Mifepristone is a drug marketed by Genbiopro and Teva Pharms Usa Inc and is included in two NDAs.
The generic ingredient in MIFEPRISTONE is mifepristone. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mifepristone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mifepristone
A generic version of MIFEPRISTONE was approved as mifepristone by GENBIOPRO on April 11th, 2019.
Summary for MIFEPRISTONE
Recent Clinical Trials for MIFEPRISTONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Women's Hospital School Of Medicine Zhejiang University | N/A |
Planned Parenthood League of Massachusetts | Phase 3 |
Corcept Therapeutics | Phase 4 |
Pharmacology for MIFEPRISTONE
Drug Class | Progestin Antagonist |
Mechanism of Action | Progestational Hormone Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for MIFEPRISTONE
Anatomical Therapeutic Chemical (ATC) Classes for MIFEPRISTONE
Paragraph IV (Patent) Challenges for MIFEPRISTONE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
KORLYM | Tablets | mifepristone | 300 mg | 202107 | 1 | 2017-12-15 |
US Patents and Regulatory Information for MIFEPRISTONE
MIFEPRISTONE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting MIFEPRISTONE
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genbiopro | MIFEPRISTONE | mifepristone | TABLET;ORAL | 091178-001 | Apr 11, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa Inc | MIFEPRISTONE | mifepristone | TABLET;ORAL | 211436-001 | Aug 3, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |