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Generated: September 25, 2017

DrugPatentWatch Database Preview

Bayer Hlthcare Company Profile

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What is the competitive landscape for BAYER HLTHCARE, and what generic alternatives to BAYER HLTHCARE drugs are available?

BAYER HLTHCARE has fifty-eight approved drugs.

There are fifty-one US patents protecting BAYER HLTHCARE drugs and there have been two Paragraph IV challenges on BAYER HLTHCARE drugs in the past three years.

There are one thousand three hundred and eighty-seven patent family members on BAYER HLTHCARE drugs in seventy-three countries.

Summary for Applicant: Bayer Hlthcare

Patents:51
Tradenames:57
Ingredients:38
NDAs:58
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
MENOSTAR
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL021674-001Jun 8, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
KYLEENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-001Apr 8, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 1988RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
LEVLITE
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28020860-002Jul 13, 1998DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
UROVIST CYSTO PEDIATRIC
diatrizoate meglumine
SOLUTION;URETERAL087731-001Sep 23, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION)021277-001Nov 30, 2001APRXYesYes► Subscribe► Subscribe ► Subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
ADEMPAS
riociguat
TABLET;ORAL204819-001Oct 8, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bayer Hlthcare
ADEMPAS
riociguat
TABLET;ORAL204819-001Oct 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Bayer Hlthcare

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
Bayer Hlthcare
MYCELEX
clotrimazole
SOLUTION;TOPICAL018181-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 1999► Subscribe► Subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-002Dec 22, 1994► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-002Oct 22, 1987► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-003Mar 23, 1998► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-002Oct 22, 1987► Subscribe► Subscribe
Bayer Hlthcare
MENOSTAR
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL021674-001Jun 8, 2004► Subscribe► Subscribe
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Paragraph IV activity for BAYER HLTHCARE drugs

Drugname Dosage Strength Tradename Submissiondate
regorafenib
Tablets40 mg
STIVARGA
9/27/2016
drospirenone and estradiol
Tablets0.25 mg/0.5 mg
ANGELIQ
1/8/2015
sorafenib tosylate
Tablets200 mg
NEXAVAR
2/28/2014
moxifloxacin hydrochloride
Injection1.6 mg/mL
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
2/7/2014
drospirenone and ethinyl estradiol and levomefolate calcium and levomefolate calcium
Tablets3 mg/0.02 mg/0.451 mg and 0.451 mg
BEYAZ
11/13/2012
drospirenone and ethinyl estradiol and levomefolate calcium and levomefolate calcium
Tablets3 mg/0.03 mg/0.451 mg and 0.451 mg
SAFYRAL
9/28/2012
azelaic acid
Gel15%
FINACEA
7/27/2012
vardenafil hydrochloride
Orally Disintegrating Tablets10 mg
STAXYN
12/22/2011
drospirenone and ethinyl estradiol and levomefolate
Tablets3 mg/0.02 mg/0.451 mg and 0.451 mg
BEYAZ
11/21/2011
desonide
Gel0.05%
DESONATE
12/1/2010
estradiol valerate and dienogest
Tablets3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg
NATAZIA
10/22/2010
ciprofloxacin
Oral Suspension250 mg/5 mL and 500 mg/ 5 mL
CIPRO
10/16/2009
vardenafil hydrochloride
Tablets2.5 mg
LEVITRA
9/4/2009
vardenafil
Tablets5 mg ad 10 mg
LEVITRA
7/10/2009
vardenafil hydrochloride
Tablets20 mg
LEVITRA
3/5/2009
drospirenone and estradiol
Tablets0.5 mg/1 mg
ANGELIQ
12/26/2007
drospirenone and ethinyl estradiol
Tablets3 mg/0.02 mg
YAZ
9/29/2006
estradiol
Transdermal System0.05 mg/day and 0.1 mg/day
CLIMARA
9/12/2005
acarbose
Tablets25 mg, 50 mg and 100 mg
PRECOSE
3/22/2005
drospirenone and ethinyl estradiol
Tablets3 mg/0.03 mg
YASMIN
1/7/2005

Premature patent expirations for BAYER HLTHCARE

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Bayer Hlthcare

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
9,101,662Compositions with modulating agents► Subscribe
9,320,705Sensation modifying topical composition foam► Subscribe
8,362,091Foamable vehicle and pharmaceutical compositions thereof► Subscribe
8,629,128Vitamin formulation► Subscribe
6,399,043 1,4,7,10-Tetraazacyclododecane butyltriols, processes for their production and pharmaceutical agents containing them► Subscribe
9,592,245Very low-dosed solid oral dosage forms for HRT► Subscribe
7,704,518Foamable vehicle and pharmaceutical compositions thereof► Subscribe
9,452,082Inserter► Subscribe
8,114,385Oleaginous pharmaceutical and cosmetic foam► Subscribe
7,314,8712-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors, for treatment of hypertension► 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 Bayer Hlthcare Drugs

Country Document Number Estimated Expiration
Cyprus1111313► Subscribe
Austria446966► Subscribe
Spain2431330► Subscribe
South Korea20050057381► Subscribe
Portugal1740163► Subscribe
Hungary215964► Subscribe
World Intellectual Property Organization (WIPO)2007042111► Subscribe
Australia760108► Subscribe
Denmark2558448► Subscribe
Slovenia1149840► 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 Bayer Hlthcare Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
00620Netherlands► SubscribePRODUCT NAME: REGORAFENIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/858 20130826
/2014Austria► SubscribePRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
5 5014-2014Slovakia► SubscribePRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140327
280Luxembourg► Subscribe91280, EXPIRES: 20210720
2006008Lithuania► SubscribePRODUCT NAME: SORAFENIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
2009 00016Denmark► Subscribe
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2013025,C1304992Lithuania► SubscribePRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
300Luxembourg► SubscribePRODUCT NAME: REGORAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES(STIVARGA)
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Merck
Queensland Health
McKinsey
Colorcon
Medtronic
Fuji
Cerilliant
Harvard Business School
UBS

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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