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Serving 500+ biopharmaceutical companies globally:

Julphar
Mallinckrodt
Healthtrust
McKinsey
Novartis
AstraZeneca
Queensland Health
Argus Health
Citi
McKesson

Generated: August 18, 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 Pharms
CORT-DOME
hydrocortisone
LOTION;TOPICAL009895-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Pharms
AZLIN
azlocillin sodium
INJECTABLE;INJECTION062388-002Sep 8, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Pharms
AZLIN
azlocillin sodium
INJECTABLE;INJECTION050562-003Sep 3, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
ADEMPAS
riociguat
TABLET;ORAL204819-004Oct 8, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bayer Healthcare Llc
CLARITIN HIVES RELIEF
loratadine
TABLET;ORAL019658-003Nov 19, 2003OTCYesYes► 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
Canada2395558► Subscribe
Australia2003279493► Subscribe
TunisiaSN06020► Subscribe
Hungary0300866► Subscribe
China1721397► 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
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
/2005Austria► SubscribePRODUCT NAME: GADOXETSAEURE DINATRIUM; NAT. REGISTRATION NO/DATE: 1-25757, 1-25758 20050302; FIRST REGISTRATION: SE 18929, 18930 20040326
90034-4Sweden► SubscribePRODUCT NAME: RADIUM-223; REG. NO/DATE: EU/1/13/873 20131113
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
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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:

Medtronic
Chinese Patent Office
Johnson and Johnson
Colorcon
US Department of Justice
McKinsey
Cipla
Moodys
Dow
Citi

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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