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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Teva
Cipla
Argus Health
Deloitte
Express Scripts
McKesson
Mallinckrodt
US Department of Justice
Harvard Business School

Generated: August 19, 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-six approved drugs.

There are fifty-eight 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 four hundred and eighty patent family members on BAYER drugs in seventy-four countries.

Summary for Applicant: BAYER

Patents:58
Tradenames:109
Ingredients:74
NDAs:126
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-002Dec 26, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
STIVARGA
regorafenib
TABLET;ORAL203085-001Sep 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Bayer Pharms
MEZLIN
mezlocillin sodium monohydrate
INJECTABLE;INJECTION050549-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Pharms
NIMOTOP
nimodipine
CAPSULE;ORAL018869-001Dec 28, 1988DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Pharms
STILPHOSTROL
diethylstilbestrol diphosphate
INJECTABLE;INJECTION010010-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Bayer

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
ULTRAVIST 300
iopromide
INJECTABLE;INJECTION020220-002May 10, 1995► Subscribe► Subscribe
Bayer Healthcare Llc
SHADE UVAGUARD
avobenzone; octinoxate; oxybenzone
LOTION;TOPICAL020045-001Dec 7, 1992► Subscribe► Subscribe
Bayer Healthcare Llc
MYCELEX
clotrimazole
CREAM;TOPICAL018183-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Bayer Hlthcare
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006► 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
9,101,662Compositions with modulating agents► Subscribe
7,928,239Inhibition of RAF kinase using quinolyl, isoquinolyl or pyridyl ureas► Subscribe
6,514,520 Stabilized antihistamine syrup► Subscribe
8,795,693Compositions with modulating agents► Subscribe
7,645,803Saccharide foamable compositions► 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
Poland354406► Subscribe
Norway329105► Subscribe
Turkey9600970► Subscribe
South Africa200503298► Subscribe
Norway332726► 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
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
1663978/01Switzerland► SubscribeFORMER OWNER: BAYER HEALTHCARE LLC, US
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
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
C019/2009Ireland► SubscribeSPC019/2009: 20091119, EXPIRES: 20220628
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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:

Julphar
Express Scripts
Farmers Insurance
Dow
Cantor Fitzgerald
Argus Health
Mallinckrodt
US Department of Justice
Moodys
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.

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