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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Baxter
Harvard Business School
Argus Health
Novartis
Cipla
Boehringer Ingelheim
Chubb
UBS

Generated: October 21, 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
DESONATE
desonide
GEL;TOPICAL021844-001Oct 20, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bayer Pharms
AZLIN
azlocillin sodium
INJECTABLE;INJECTION050562-001Sep 3, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010ABRXNoNo► Subscribe► SubscribeY ► Subscribe
Bayer Hlthcare
ADEMPAS
riociguat
TABLET;ORAL204819-003Oct 8, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bayer Pharms
VI-DOM-A
vitamin a palmitate
CAPSULE;ORAL080972-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
ADEMPAS
riociguat
TABLET;ORAL204819-003Oct 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
PRECOSE
acarbose
TABLET;ORAL020482-004May 29, 1997ABRXYesYes► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
UROVIST CYSTO
diatrizoate meglumine
SOLUTION;URETERAL087729-001Sep 23, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 1997ABRXYesYes► Subscribe► Subscribe► Subscribe
Bayer Pharms
NIMOTOP
nimodipine
CAPSULE;ORAL018869-001Dec 28, 1988DISCNYesNo► 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
YASMIN
drospirenone; ethinyl estradiol
TABLET;ORAL-28021098-001May 11, 2001► Subscribe► Subscribe
Bayer Hlthcare
BEYAZ
drospirenone; ethinyl estradiol; levomefolate calcium
TABLET;ORAL022532-001Sep 24, 2010► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 1997► Subscribe► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION021037-001Mar 10, 2000► Subscribe► Subscribe
Bayer Healthcare Llc
CLARITIN
loratadine
SYRUP;ORAL020641-002Nov 27, 2002► Subscribe► Subscribe
Bayer Hlthcare
MAGNEVIST
gadopentetate dimeglumine
INJECTABLE;INJECTION021037-001Mar 10, 2000► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-003Oct 22, 1987► Subscribe► Subscribe
Bayer Healthcare Llc
MYCELEX
clotrimazole
CREAM;TOPICAL018183-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021473-001Dec 13, 2002► 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
9,713,643Foamable carriers► Subscribe
8,129,386Fused azole-pyrimidine derivatives► Subscribe
9,636,405Foamable vehicle and pharmaceutical compositions thereof► Subscribe
5,798,092 Derivatized DTPA complexes pharmaceutical agents containing these compounds, their use, and processes for their production► Subscribe
7,029,659Mousse composition► Subscribe
6,517,847 Topical gel delivery system► Subscribe
8,298,515Vitamin formulation► Subscribe
RE45198Omeprazole solution and method for using same► Subscribe
8,114,385Oleaginous pharmaceutical and cosmetic foam► Subscribe
6,566,360 2-phenyl substituted imidatriazinones as phosphodiesterase inhibitors► 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
Japan2002524490► Subscribe
South Korea20050019871► Subscribe
China104688697► Subscribe
European Patent Office2977043► Subscribe
Denmark2352470► Subscribe
New Zealand616198► Subscribe
Hungary230154► Subscribe
South Africa200707638► Subscribe
South Korea20040047771► Subscribe
Turkey200101310► 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
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
643Luxembourg► Subscribe91643, EXPIRES: 20211022
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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
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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 leading biopharmaceutical companies globally:

McKinsey
Fish and Richardson
Cantor Fitzgerald
Johnson and Johnson
Cipla
Boehringer Ingelheim
Cerilliant
Argus Health
Covington
Chubb

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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