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Ulipristal acetate - Generic Drug Details
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What are the generic sources for ulipristal acetate and what is the scope of patent protection?
Ulipristal acetate
is the generic ingredient in two branded drugs marketed by Lab Hra Pharma and Teva Pharms Usa, and is included in two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ulipristal acetate has sixty-five patent family members in twenty-eight countries.
There are six drug master file entries for ulipristal acetate. Three suppliers are listed for this compound.
Summary for ulipristal acetate
| International Patents: | 65 |
| US Patents: | 8 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 50 |
| Patent Applications: | 931 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ulipristal acetate |
| DailyMed Link: | ulipristal acetate at DailyMed |
Recent Clinical Trials for ulipristal acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Utah | Early Phase 1 |
| Merck Sharp & Dohme Corp. | Early Phase 1 |
| HOPE Research Center, Ho Chi Minh City, Viet Nam | Phase 4 |
Pharmacology for ulipristal acetate
| Drug Class | Progesterone Agonist/Antagonist |
| Mechanism of Action | Selective Progesterone Receptor Modulators |
Paragraph IV (Patent) Challenges for ULIPRISTAL ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ELLA | TABLET;ORAL | ulipristal acetate | 022474 | 2014-08-13 |
US Patents and Regulatory Information for ulipristal acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Teva Pharms Usa | LOGILIA | ulipristal acetate | TABLET;ORAL | 207952-001 | Feb 13, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ulipristal acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2011006106 | Start Trial |
| Hungary | E030762 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011091890 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011069871 | Start Trial |
| Lithuania | 2365800 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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