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:	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

Drug patent expirations by year for ELLA

Pharmacology for ELLA

Drug Class	Progesterone Agonist/Antagonist
Mechanism of Action	Selective Progesterone Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for ELLA

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03XB	Progesterone receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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

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Glossary

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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

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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.

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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