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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Chubb
Johnson and Johnson
Moodys
AstraZeneca
Teva
UBS
Citi
Medtronic

Generated: August 16, 2017

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Drospirenone; estradiol - Generic Drug Details

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What are the generic drug sources for drospirenone; estradiol and what is the scope of drospirenone; estradiol patent protection?

Drospirenone; estradiol
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has sixty-four patent family members in thirty-two countries.

There are ten drug master file entries for drospirenone; estradiol. Two suppliers are listed for this compound.

Summary for Generic Name: drospirenone; estradiol

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list10
Suppliers / Packagers: see list2
Clinical Trials: see list710
Drug Prices:see low prices
DailyMed Link:drospirenone; estradiol at DailyMed

Pharmacology for Ingredient: drospirenone; estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
ANGELIQ
drospirenone; estradiol
TABLET;ORAL021355-002Sep 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
ANGELIQ
drospirenone; estradiol
TABLET;ORAL021355-001Feb 29, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: drospirenone; estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
ANGELIQ
drospirenone; estradiol
TABLET;ORAL021355-002Sep 28, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: drospirenone; estradiol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,592,245Very low-dosed solid oral dosage forms for HRT► Subscribe
6,121,465 Process for production drospirenone and intermediate products of the process► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: drospirenone; estradiol

Country Document Number Estimated Expiration
Spain2438941► Subscribe
World Intellectual Property Organization (WIPO)9806738► Subscribe
Denmark2168974► Subscribe
Australia2011240102► Subscribe
Canada2795801► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DROSPIRENONE; ESTRADIOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022France► SubscribePRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2006009Lithuania► SubscribePRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Teva
Chinese Patent Office
Federal Trade Commission
Novartis
Chubb
Baxter
Moodys
QuintilesIMS
AstraZeneca

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 verifification 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.

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