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
Summary for ELLA
International Patents: | 65 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 75 |
Patent Applications: | 711 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for ELLA
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 STUDYHRA2914-5016
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 | ||
>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 |
---|---|---|---|
Japan | 2012523446 | ⤷ Try a Trial | |
Russian Federation | 2011127989 | ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА | ⤷ Try a Trial |
South Africa | 201104137 | ULIPRISTAL ACETATE TABLETS | ⤷ Try a Trial |
Serbia | 55331 | POSTUPAK ZA KONTRACEPCIJU PO POTREBI (METHOD FOR ON-DEMAND CONTRACEPTION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |