Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Cerilliant
Colorcon
Farmers Insurance
UBS
McKinsey
Queensland Health
Cantor Fitzgerald
Cipla
Johnson and Johnson
Medtronic

Generated: October 18, 2017

DrugPatentWatch Database Preview

Drospirenone; estradiol - Generic Drug Details

« Back to Dashboard

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 seventy-four patent family members in thirty-two countries and three supplementary protection certificates in three countries.

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

Summary for Generic Name: drospirenone; estradiol

US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list10
Suppliers / Packagers: see list2
Clinical Trials: see list722
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: drospirenone; estradiol

Country Document Number Estimated Expiration
New Zealand333697► Subscribe
Poland331530► Subscribe
Brazil9711060► Subscribe
Taiwan201204368► Subscribe
Argentina080912► Subscribe
Slovenia1149841► Subscribe
Slovenia1149840► Subscribe
Germany19633685► Subscribe
European Patent Office2168974► Subscribe
Poland187474► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
QuintilesIMS
Harvard Business School
Mallinckrodt
Cerilliant
Farmers Insurance
Express Scripts
Boehringer Ingelheim
US Department of Justice
Baxter

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot