ELLA Drug Patent Profile
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Which patents cover Ella, and what generic alternatives are available?
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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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: | 463 |
| 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.
Patents protecting ELLA
Method for on-demand contraception
Patent Number: ⤷ Sign Up
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Patented Use: A METHOD FOR CONTRACEPTION COMPRISING THE STEP OF ORAL ADMINISTRATION A DOSAGE OF 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE
Method for on-demand contraception
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR CONTRACEPTION, THE METHOD COMPRISING ADMINISTERING A TABLET COMPRISING 20 MG TO 30 MG OF ULIPRISTAL ACETATE TO A WOMAN WITHIN 120 HOURS AFTER AN UNPROTECTED INTERCOURSE
Method for providing emergency contraception
Patent Number: ⤷ Sign Up
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Patented Use: ELLA IS A PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
Ulipristal acetate tablets
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Ulipristal acetate tablets
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Method for post coital contraception in overweight or obese female subjects using ulipristal acetate
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Patented Use: METHOD FOR PROVIDING POST COITAL CONTRACEPTION TO A WOMAN BY ADMINISTERING ABOUT 30 MG OF ULIPRISTAL ACETATE WITHIN ABOUT 120 HOURS AFTER INTERCOURSE, WHEREIN THE WOMAN IS OVERWEIGHTHAVING A BMI OF 25 TO 29.99
Method for on-demand contraception
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD FOR CONTRACEPTION TO A WOMAN COMPRISING ADMINISTERING TO THE WOMAN 30MG OF ULIPRISTAL ACETATE MORE THAN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE
Ulipristal acetate tablets
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FDA Regulatory Exclusivity protecting ELLA
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY HRA2914-5016
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lab Hra Pharma | ELLA | ulipristal acetate | TABLET;ORAL | 022474-001 | Aug 13, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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: ⤷ Sign Up
Brazil
Patent: 0922796
Patent: COMPRIMIDO FARMACÊUTICO PARA ADMINISTRAÇÃO POR VIA ORAL E MÉTODO DE FABRICAÇÃO DO MESMO
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 45084
Patent: COMPRIMES D'ULIPRISTAL ACETATE (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2245173
Patent: Ulipristal acetate tablets
Estimated Expiration: ⤷ Sign Up
Patent: 5267168
Patent: Ulipristal Acetate Tablets
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 00186
Patent: TABLETAS DE ACETATO DE ULIPRISTAL
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0161262
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18099
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 65800
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 65800
Patent: COMPRIMÉS D'ULIPRISTAL ACÉTATE (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
Patent: 03445
Patent: COMPRIMÉS D'ACÉTATE D'ULIPRISTAL (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 32134
Patent: 烏利司他醋酸片 (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30762
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3247
Patent: טבליות אוליפריסטל אצטט (Ulipristal acetate tablets)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 84502
Estimated Expiration: ⤷ Sign Up
Patent: 51727
Estimated Expiration: ⤷ Sign Up
Patent: 12511041
Estimated Expiration: ⤷ Sign Up
Patent: 15107994
Patent: ウリプリスタール酢酸エステル錠 (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 65800
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 3358
Patent: TABLETAS DE ACETATO DE ULIPRISTAL. (ULIPRISTAL ACETATE TABLETS.)
Estimated Expiration: ⤷ Sign Up
Patent: 11006106
Patent: TABLETAS DE ACETATO DE ULIPRISTAL. (ULIPRISTAL ACETATE TABLETS.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3498
Patent: ULIPRISTAL ACETATE TABLETS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 65800
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 65800
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 92853
Patent: ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА (TABLETS OF ULIPRISTAL ACETATE)
Estimated Expiration: ⤷ Sign Up
Patent: 11127989
Patent: ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 01600372
Patent: COMPRESSE DI ULIPRISTAL ACETATO
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 209
Patent: TABLETE ULIPRISTAL ACETATA (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 65800
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1104137
Patent: ULIPRISTAL ACETATE TABLETS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1733533
Estimated Expiration: ⤷ Sign Up
Patent: 110097936
Patent: 울리프리스탈 아세테이트 정제 (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 96554
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 1863
Patent: ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА;ТАБЛЕТКИ НА ОСНОВІ УЛІПРИСТАЛУ АЦЕТАТУ (ULIPRISTAL ACETATE TABLETS)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Japan | 5784502 | ⤷ Sign Up | |
| Lithuania | 2365800 | ⤷ Sign Up | |
| Spain | 2596554 | ⤷ Sign Up | |
| European Patent Office | 3106167 | PROCÉDÉ DE CONTRACEPTION À LA DEMANDE (METHOD FOR ON-DEMAND CONTRACEPTION) | ⤷ Sign Up |
| European Patent Office | 3103445 | COMPRIMÉS D'ACÉTATE D'ULIPRISTAL (ULIPRISTAL ACETATE TABLETS) | ⤷ Sign Up |
| Ukraine | 101863 | ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА;ТАБЛЕТКИ НА ОСНОВІ УЛІПРИСТАЛУ АЦЕТАТУ (ULIPRISTAL ACETATE TABLETS) | ⤷ Sign Up |
| San Marino | T201600399 | METODO DI CONTRACCEZIONE A RICHIESTA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >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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