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Last Updated: August 7, 2020

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ALORA Drug Profile

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

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

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

US ANDA Litigation and Generic Entry Outlook for Alora

A generic version of ALORA was approved as estradiol by MAYNE PHARMA on March 14th, 1996.

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

Expired US Patents for ALORA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-003 Dec 20, 1996   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-002 Dec 20, 1996   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-001 Dec 20, 1996   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-004 Apr 5, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ALORA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 9/2009 Austria   Start Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
1453521 C201630040 Spain   Start Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
McKinsey
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Merck
AstraZeneca

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