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ELLA Drug Profile
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When do Ella patents expire, and what generic alternatives are available?
Ella is a drug marketed by Lab Hra Pharma and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-five patent family members in twenty-eight countries.
The generic ingredient in ELLA is ulipristal acetate. There are six drug master file entries for this compound. Additional details are available on the ulipristal acetate profile page.
US ANDA Litigation and Generic Entry Outlook for Ella
Ella was eligible for patent challenges on August 13, 2014.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ELLA
| International Patents: | 65 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 61 |
| Patent Applications: | 51 |
| Drug Prices: | Drug price information for ELLA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELLA |
| DailyMed Link: | ELLA at DailyMed |
Synonyms for ELLA
| (10S,11S,14R,15S,17R)-14-acetyl-17-[4-(dimethylamino)phenyl]-15-methyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-1,6-dien-14-yl acetate |
| (11alpha,13alpha,17beta)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-yl acetate |
| (11b)-17-(Acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione |
| (11beta,17alpha)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-yl acetate |
| (11beta)-17-(Acetyloxy)-11-(4-(dimethylamino)phenyl)-19-norpregna-4,9-diene-3,20-dione |
| (11beta)-17-(Acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione |
| (8S,11R,13S,14S,17R)-17-acetyl-11-(4-(dimethylamino)phenyl)-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate |
| [(8S,11R,13S,14S,17R)-17-acetyl-11-(4-dimethylaminophenyl)-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl] acetate |
| [(8s,11r,13s,14s,17r)-17-Acetyl-11-[4-(Dimethylamino)phenyl]-13-Methyl-3-Oxo-1,2,6,7,8,11,12,14,15,16-Decahydrocyclopenta[a]phenanthren-17-Yl] Acetate |
| 126784-99-4 |
| 17-Acetoxy-11-(4-N,N-dimethylaminophenyl)pregna-4,9-diene-3,20-dione |
| 17beta-acetyl-11beta-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17alpha-yl acetate |
| 19-Norpregna-4,9-diene-3,20-dione, 17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-, (11beta)- |
| 19-Norpregna-4,9-diene-3,20-dione,17-(acetyloxy)-11-[4-(dimethylamino)phenyl]-, (11b)- |
| 4oar |
| 5-(Hydroxymethyl)-alpha,alpha,alpha,alpha-tetramethyl-1,3-benzenediacetonitrile |
| 784A994 |
| AB01566874_01 |
| AC1L2Y8A |
| AKOS026750526 |
| AMX10180 |
| BDBM50375424 |
| BRD-K64381438-001-03-8 |
| C30H37NO4 |
| CBD 2914 |
| CBD 2914; VA 2914; (11b)-17-(Acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione |
| CDB 2914 |
| CDB-2914 |
| CHEBI:71025 |
| CHEMBL260538 |
| CS-1157 |
| D09687 |
| DTXSID30155294 |
| EllaOne |
| EllaOne|||Esmya |
| EN300-220766 |
| FT-0675731 |
| GTPL7460 |
| Hrp-2000 |
| HY-16508 |
| J-005436 |
| KB-81383 |
| KS-00000Z24 |
| MolPort-006-170-077 |
| NCGC00378913-02 |
| OOLLAFOLCSJHRE-ZHAKMVSLSA-N |
| RTI 3021-012 |
| SC-44720 |
| SCHEMBL544957 |
| U0102 |
| Ulipristal (acetate) |
| Ulipristal acet |
| Ulipristal acetate |
| Ulipristal acetate (JAN/USAN) |
| Ulipristal acetate [USAN] |
| Ulipristal acetate, >=98% (HPLC) |
| Ulipristal acetate(CDB2914) |
| Ulipristal-Acetate |
| UNII-YF7V70N02B |
| VA2914 |
| W-5201 |
| X4788 |
| YF7V70N02B |
| Z2216208644 |
| ZINC3920657 |
Paragraph IV (Patent) Challenges for ELLA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ELLA | TABLET;ORAL | ulipristal acetate | 022474 | 2014-08-13 |
US Patents and Regulatory Information for ELLA
| 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 | Y | 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 ELLA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 201107543 | Start Trial |
| European Patent Office | 3103445 | Start Trial |
| Slovenia | 2365800 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2010066749 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
