ALORA Drug Patent Profile

Which patents cover Alora, and when can generic versions of Alora launch?

Alora is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ALORA is estradiol. There are seventy-five drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alora

A generic version of ALORA was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for ALORA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	4,189
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ALORA
What excipients (inactive ingredients) are in ALORA?	ALORA excipients list
DailyMed Link:	ALORA at DailyMed

See drug prices for ALORA

Anatomical Therapeutic Chemical (ATC) Classes for ALORA

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for ALORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-003	Dec 20, 1996		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996		DISCN	No	No
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996		DISCN	No	No

Expired US Patents for ALORA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-001	Dec 20, 1996
Abbvie	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-004	Apr 5, 2002

International Patents for ALORA

See the table below for patents covering ALORA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H06503252
Australia	9175791
Australia	651165
Canada	2098195	DISPOSITIF D'ADMINISTRATION, PAR VOIE PERCUTANEE, DE MEDICAMENTS DONT LA CONCENTRATION EST SOUS-SATUREE; CE DISPOSITIF PERMET UN MEILLEUR ECOULEMENT DU MEDICAMENT (SUBSATURATED TRANSDERMAL DRUG DELIVERY DEVICE EXHIBITING ENHANCED DRUG FLUX)

Supplementary Protection Certificates for ALORA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211