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Serving leading biopharmaceutical companies globally:

Argus Health
Baxter
Moodys
AstraZeneca
Farmers Insurance
Johnson and Johnson
Teva
Dow
Harvard Business School
Daiichi Sankyo

Generated: October 23, 2017

DrugPatentWatch Database Preview

BAYER Company Profile

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

BAYER has one hundred and twenty-seven approved drugs.

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

There are one thousand six hundred and seventy-two patent family members on BAYER drugs in seventy-six countries and one hundred and seventy-nine supplementary protection certificates in sixteen countries.

Summary for Applicant: BAYER

International Patents:1672
US Patents:62
Tradenames:110
Ingredients:75
NDAs:127
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
SKYLA
levonorgestrel
INTRAUTERINE DEVICE;INTRAUTERINE203159-001Jan 9, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Bayer Healthcare Llc
OCUCLEAR
oxymetazoline hydrochloride
SOLUTION/DROPS;OPHTHALMIC018471-001May 30, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe
Bayer Healthcare Llc
GYNE-LOTRIMIN 3 COMBINATION PACK
clotrimazole
CREAM, TABLET;TOPICAL, VAGINAL020526-002Jul 29, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
XOFIGO
radium ra-223 dichloride
SOLUTION;INTRAVENOUS203971-001May 15, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-001Sep 26, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
ADEMPAS
riociguat
TABLET;ORAL204819-004Oct 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021473-002Aug 28, 2003DISCNNoNo► Subscribe► SubscribeY► Subscribe
Bayer Healthcare Llc
CHLOR-TRIMETON
chlorpheniramine maleate
TABLET, EXTENDED RELEASE;ORAL007638-002Approved Prior to Jan 1, 1982OTCYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Bayer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms
BAYCOL
cerivastatin sodium
TABLET;ORAL020740-003Jun 26, 1997► Subscribe► Subscribe
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION019596-001Jun 2, 1988► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-003Oct 22, 1987► Subscribe► Subscribe
Bayer Hlthcare
MYCELEX
clotrimazole
SOLUTION;TOPICAL018181-001Approved Prior to Jan 1, 1982► 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
CLIMARA PRO
estradiol; levonorgestrel
FILM, EXTENDED RELEASE;TRANSDERMAL021258-001Nov 21, 2003► Subscribe► Subscribe
Bayer Pharms
BAYCOL
cerivastatin sodium
TABLET;ORAL020740-002Jun 26, 1997► Subscribe► Subscribe
Bayer Pharms
BAYCOL
cerivastatin sodium
TABLET;ORAL020740-005May 24, 1999► Subscribe► Subscribe
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Paragraph IV activity for BAYER 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
omeprazole and sodium bicarbonate
Capsules20 mg/1100 mg
ZEGERID OTC
4/20/2010
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

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Bayer

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
8,629,128Vitamin formulation► Subscribe
7,645,803Saccharide foamable compositions► Subscribe
8,840,869Body cavity foams► Subscribe
7,029,659Mousse composition► Subscribe
7,928,239Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas► Subscribe
RE45198Omeprazole solution and method for using same► Subscribe
8,242,147Aryl ureas with angiogenisis inhibiting activity► Subscribe
9,452,082Inserter► Subscribe
9,050,253Oleaginous pharmaceutical and cosmetic foam► Subscribe
8,129,386Fused azole-pyrimidine derivatives► 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 Drugs

Country Document Number Estimated Expiration
MexicoPA01006823► Subscribe
Estonia04221► Subscribe
Spain2320626► Subscribe
Australia1267400► Subscribe
Portugal1690853► Subscribe
South Korea20070067248► Subscribe
European Patent Office1927354► Subscribe
China102816113► Subscribe
World Intellectual Property Organization (WIPO)2005009961► Subscribe
Peru04002001► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8 50005-2014Slovakia► SubscribePRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
0242Netherlands► Subscribe
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
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
643Luxembourg► Subscribe91643, EXPIRES: 20211022
14/033Ireland► SubscribePRODUCT NAME: RADIUM-223 AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/873 20131113
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
C/GB03/034United Kingdom► SubscribePRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313
0130034 00099Estonia► SubscribePRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
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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 leading biopharmaceutical companies globally:

QuintilesIMS
Covington
Merck
Baxter
Queensland Health
Farmers Insurance
McKinsey
AstraZeneca
Chinese Patent Office
US Department of Justice

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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