ELLA Drug Patent Profile
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When do Ella patents expire, and when can generic versions of Ella launch?
Ella is a drug marketed by Lab Hra Pharma and is included in one NDA. There are eight 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. Four suppliers are listed for this compound. Additional details are available on the ulipristal acetate profile page.
DrugPatentWatch® 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
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Questions you can ask:
- What is the 5 year forecast for ELLA?
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Summary for ELLA
International Patents: | 65 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 76 |
Patent Applications: | 467 |
Drug Prices: | Drug price information for ELLA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELLA |
What excipients (inactive ingredients) are in ELLA? | ELLA excipients list |
DailyMed Link: | ELLA at DailyMed |
Pharmacology for ELLA
Drug Class | Progesterone Agonist/Antagonist |
Mechanism of Action | Selective Progesterone Receptor Modulators |
Paragraph IV (Patent) Challenges for ELLA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ELLA | Tablets | ulipristal acetate | 30 mg | 022474 | 1 | 2014-08-13 |
US Patents and Regulatory Information for ELLA
ELLA is protected by eight US patents and one FDA Regulatory Exclusivity.
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 | 8,426,392 | ⤷ Subscribe | ⤷ Subscribe | |||
Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | 9,844,510 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | 10,159,681 | ⤷ Subscribe | ⤷ Subscribe | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ELLA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Laboratoire HRA Pharma | ellaOne | ulipristal acetate | EMEA/H/C/001027 Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure. |
Authorised | no | no | no | 2009-05-15 | |
Gedeon Richter Plc. | Ulipristal Acetate Gedeon Richter | ulipristal acetate | EMEA/H/C/005017 Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery. |
Withdrawn | no | no | no | 2018-08-27 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ELLA
When does loss-of-exclusivity occur for ELLA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 09326084
Patent: Ulipristal acetate tablets
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0922796
Patent: COMPRIMIDO FARMACÊUTICO PARA ADMINISTRAÇÃO POR VIA ORAL E MÉTODO DE FABRICAÇÃO DO MESMO
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 45084
Patent: COMPRIMES D'ULIPRISTAL ACETATE (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
China
Patent: 2245173
Patent: Ulipristal acetate tablets
Estimated Expiration: ⤷ Subscribe
Patent: 5267168
Patent: Ulipristal Acetate Tablets
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 00186
Patent: TABLETAS DE ACETATO DE ULIPRISTAL
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0161262
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 18099
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 65800
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 65800
Patent: COMPRIMÉS D'ULIPRISTAL ACÉTATE (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Patent: 03445
Patent: COMPRIMÉS D'ACÉTATE D'ULIPRISTAL (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 32134
Patent: 烏利司他醋酸片 (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 30762
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 3247
Patent: טבליות אוליפריסטל אצטט (Ulipristal acetate tablets)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 84502
Estimated Expiration: ⤷ Subscribe
Patent: 51727
Estimated Expiration: ⤷ Subscribe
Patent: 12511041
Estimated Expiration: ⤷ Subscribe
Patent: 15107994
Patent: ウリプリスタール酢酸エステル錠 (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 65800
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 3358
Patent: TABLETAS DE ACETATO DE ULIPRISTAL. (ULIPRISTAL ACETATE TABLETS.)
Estimated Expiration: ⤷ Subscribe
Patent: 11006106
Patent: TABLETAS DE ACETATO DE ULIPRISTAL. (ULIPRISTAL ACETATE TABLETS.)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 3498
Patent: ULIPRISTAL ACETATE TABLETS
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 65800
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 65800
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 92853
Patent: ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА (TABLETS OF ULIPRISTAL ACETATE)
Estimated Expiration: ⤷ Subscribe
Patent: 11127989
Patent: ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА
Estimated Expiration: ⤷ Subscribe
San Marino
Patent: 01600372
Patent: COMPRESSE DI ULIPRISTAL ACETATO
Estimated Expiration: ⤷ Subscribe
Serbia
Patent: 209
Patent: TABLETE ULIPRISTAL ACETATA (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 65800
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1104137
Patent: ULIPRISTAL ACETATE TABLETS
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1733533
Estimated Expiration: ⤷ Subscribe
Patent: 110097936
Patent: 울리프리스탈 아세테이트 정제 (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 96554
Estimated Expiration: ⤷ Subscribe
Ukraine
Patent: 1863
Patent: ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА;ТАБЛЕТКИ НА ОСНОВІ УЛІПРИСТАЛУ АЦЕТАТУ (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Subscribe
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ELLA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101733533 | ⤷ Subscribe | |
Russian Federation | 2011127989 | ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА | ⤷ Subscribe |
China | 102395373 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
ELLA Market Analysis and Financial Projection Experimental
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