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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Chinese Patent Office
Farmers Insurance
Teva
Johnson and Johnson
Julphar
Deloitte
McKesson
Express Scripts
McKinsey

Generated: August 20, 2017

DrugPatentWatch Database Preview

BAYER HLTHCARE Company Profile

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What is the competitive landscape for BAYER HLTHCARE, and when can generic versions of BAYER HLTHCARE drugs launch?

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
KYLEENA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE208224-001Sep 16, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
ANGELIQ
drospirenone; estradiol
TABLET;ORAL021355-002Sep 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
BILIVIST
ipodate sodium
CAPSULE;ORAL087768-001Aug 11, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-002Dec 26, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
ULTRAVIST 300 IN PLASTIC CONTAINER
iopromide
INJECTABLE;INJECTION020220-005Nov 18, 2008RXYesYes► 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
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
ULTRAVIST 150
iopromide
INJECTABLE;INJECTION020220-004May 10, 1995► Subscribe► Subscribe
Bayer Hlthcare
GADAVIST
gadobutrol
SOLUTION;INTRAVENOUS201277-001Mar 14, 2011► Subscribe► Subscribe
Bayer Hlthcare
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION)021277-001Nov 30, 2001► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-004Oct 22, 1987► 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
7,645,803Saccharide foamable compositions► Subscribe
6,890,922 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
8,362,091Foamable vehicle and pharmaceutical compositions thereof► Subscribe
9,636,405Foamable vehicle and pharmaceutical compositions thereof► Subscribe
8,486,376Moisturizing foam containing lanolin► 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
South Africa200710619► Subscribe
Australia760108► Subscribe
Argentina048830► Subscribe
World Intellectual Property Organization (WIPO)2008075207► 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 Bayer Hlthcare Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
400019Hungary► SubscribePRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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
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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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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Novartis
Johnson and Johnson
Covington
McKinsey
Colorcon
Farmers Insurance
Fish and Richardson
Medtronic

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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ISSN: 2162-2639

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