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. Three 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.
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Questions you can ask:
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Summary for MIFEPRISTONE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 196 |
| Patent Applications: | 4,965 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIFEPRISTONE |
| What excipients (inactive ingredients) are in MIFEPRISTONE? | MIFEPRISTONE excipients list |
| DailyMed Link: | MIFEPRISTONE at DailyMed |
Recent Clinical Trials for MIFEPRISTONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Astellas Pharma US, Inc. | Phase 2 |
| Memorial Sloan Kettering Cancer Center | Phase 2 |
| Breast Cancer Research Foundation | Phase 2 |
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa Inc | MIFEPRISTONE | mifepristone | TABLET;ORAL | 211436-001 | Aug 3, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
