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Last Updated: April 13, 2024

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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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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ulipristal acetate tablets
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Method for post coital contraception in overweight or obese female subjects using ulipristal acetate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting ELLA

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY HRA2914-5016
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0922796
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 45084
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2245173
Estimated Expiration: ⤷  Try a Trial

Patent: 5267168
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 00186
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0161262
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18099
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 65800
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 65800
Estimated Expiration: ⤷  Try a Trial

Patent: 03445
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 32134
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 30762
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3247
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 84502
Estimated Expiration: ⤷  Try a Trial

Patent: 51727
Estimated Expiration: ⤷  Try a Trial

Patent: 12511041
Estimated Expiration: ⤷  Try a Trial

Patent: 15107994
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 65800
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 3358
Estimated Expiration: ⤷  Try a Trial

Patent: 11006106
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3498
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 65800
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 65800
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 92853
Estimated Expiration: ⤷  Try a Trial

Patent: 11127989
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600372
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 209
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 65800
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1104137
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1733533
Estimated Expiration: ⤷  Try a Trial

Patent: 110097936
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 96554
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 1863
Estimated Expiration: ⤷  Try a Trial

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
European Patent Office 2365800 COMPRIMÉS D'ULIPRISTAL ACÉTATE (ULIPRISTAL ACETATE TABLETS) ⤷  Try a Trial
Denmark 2365800 ⤷  Try a Trial
New Zealand 615430 Method for on-demand contraception ⤷  Try a Trial
Japan 2012523446 ⤷  Try a Trial
Croatia P20161262 ⤷  Try a Trial
>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.