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Bayer Hlthcare Company Profile

What is the competitive landscape for BAYER HLTHCARE, and what generic alternatives to BAYER HLTHCARE drugs are available?

BAYER HLTHCARE has fifty-eight approved drugs.

There are forty-six US patents protecting BAYER HLTHCARE drugs.

There are one thousand three hundred and eighty-five patent family members on BAYER HLTHCARE drugs in seventy-two countries and one hundred and ten supplementary protection certificates in sixteen countries.

Summary for Bayer Hlthcare

International Patents:	1385
US Patents:	46
Tradenames:	57
Ingredients:	38
NDAs:	58

Drugs and US Patents for Bayer Hlthcare

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011		RX	Yes	Yes		➤ Sign Up				➤ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003		DISCN	No	No	7,709,022*PED	➤ Sign Up			Y	➤ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003		RX	Yes	No	7,696,206	➤ Sign Up	Y	Y		➤ Sign Up
Bayer Hlthcare	BILTRICIDE	praziquantel	TABLET;ORAL	018714-001	Dec 29, 1982	AB	RX	Yes	Yes		➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for Bayer Hlthcare

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-004	Mar 14, 2011	5,980,864	➤ Sign Up
Bayer Hlthcare	MENOSTAR	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	021674-001	Jun 8, 2004	5,891,868	➤ Sign Up
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	5,362,475	➤ Sign Up
Bayer Hlthcare	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	4,713,394	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for BAYER HLTHCARE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	3 mg/0.02 mg/0.451 mg and 0.451 mg	➤ Subscribe	2012-11-13
➤ Subscribe	Tablets	25 mg, 50 mg and 100 mg	➤ Subscribe	2005-03-22
➤ Subscribe	Tablets	200 mg	➤ Subscribe	2014-02-28
➤ Subscribe	Tablets	3 mg/0.02 mg	➤ Subscribe	2006-09-29
➤ Subscribe	Tablets	40 mg	➤ Subscribe	2016-09-27
➤ Subscribe	Transdermal System	0.05 mg/day and 0.1 mg/day	➤ Subscribe	2005-09-12
➤ Subscribe	Tablets	0.5 mg, 1 mg,1.5 mg, 2 mg and2.5 mg	➤ Subscribe	2017-10-10
➤ Subscribe	Tablets	5 mg ad 10 mg	➤ Subscribe	2009-07-10
➤ Subscribe	Oral Suspension	250 mg/5 mL and 500 mg/ 5 mL	➤ Subscribe	2009-10-16
➤ Subscribe	Gel	0.05%	➤ Subscribe	2010-12-01
➤ Subscribe	Orally Disintegrating Tablets	10 mg	➤ Subscribe	2011-12-22
➤ Subscribe	Tablets	3 mg/0.03 mg/0.451 mg and 0.451 mg	➤ Subscribe	2012-09-28
➤ Subscribe	Injection	1.6 mg/mL	➤ Subscribe	2014-02-07
➤ Subscribe	Tablets	0.5 mg/1 mg	➤ Subscribe	2007-12-26
➤ Subscribe	Tablets	0.25 mg/0.5 mg	➤ Subscribe	2015-01-08
➤ Subscribe	Tablets	3 mg/0.03 mg	➤ Subscribe	2005-01-07
➤ Subscribe	Topical Foam	15%	➤ Subscribe	2017-09-14
➤ Subscribe	Tablets	20 mg	➤ Subscribe	2009-03-05
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2009-09-04
➤ Subscribe	Tablets	3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg	➤ Subscribe	2010-10-22
➤ Subscribe	Tablets	3 mg/0.02 mg/0.451 mg and 0.451 mg	➤ Subscribe	2011-11-21
➤ Subscribe	Gel	15%	➤ Subscribe	2012-07-27

Premature patent expirations for BAYER HLTHCARE

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date
➤ Sign Up	➤ Sign Up

Non-Orange Book US 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.

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Patent No.	Title	Estimated Patent Expiration
9,713,643	Foamable carriers	➤ Sign Up
8,263,580	Vitamin formulation	➤ Sign Up
8,741,265	Penetrating pharmaceutical foam	➤ Sign Up
9,539,208	Foam prepared from nanoemulsions and uses	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for Bayer Hlthcare Drugs

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Country	Document Number	Estimated Expiration
Canada	2776692	➤ Sign Up
Ukraine	95984	➤ Sign Up
Hong Kong	1042251	➤ Sign Up
Russian Federation	2260429	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for Bayer Hlthcare Drugs

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014 00028	Denmark	➤ Sign Up	PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
0130034 00099	Estonia	➤ Sign Up	PRODUCT NAME: REGORAFENIIB;REG NO/DATE: K(2013)5622 (LOPLIK) 26.08.2013
C0022	France	➤ Sign Up	PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2006000059	Germany	➤ Sign Up	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/342/001 20060719
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Summary for Bayer Hlthcare

Paragraph IV (Patent) Challenges for BAYER HLTHCARE drugs

Premature patent expirations for BAYER HLTHCARE

Expiration due to failure to pay maintenance fee

Similar Applicant Names

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