BAYER Company Profile

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BAYER has one hundred and twenty-four approved drugs.

There are fifty-four US patents protecting BAYER drugs. There is one tentative approval on BAYER drugs.

There are one thousand one hundred and five patent family members on BAYER drugs in sixty countries and two hundred supplementary protection certificates in twenty countries.

International Patents:	1105
US Patents:	54
Tradenames:	109
Ingredients:	73
NDAs:	124
Patent Litigation for BAYER:	See patent lawsuits for BAYER

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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	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003	AB2	RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-004	Aug 19, 2003		DISCN	Yes	No	8,273,876	⤷ Sign Up				⤷ Sign Up
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	DTIC-DOME	dacarbazine	INJECTABLE;INJECTION	017575-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-006	Jul 24, 2000		DISCN	No	No		⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	019596-001	Jun 2, 1988	5,362,475	⤷ Sign Up
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-001	Dec 22, 1994	5,223,261	⤷ Sign Up
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-001	Jun 26, 1997	5,177,080	⤷ Sign Up
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985	3,644,627	⤷ Sign Up
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	7,709,022*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	15C0050	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1506193	92419	Luxembourg	⤷ Sign Up	PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
3106463	PA2020504	Lithuania	⤷ Sign Up	PRODUCT NAME: LAROTREKTINIBAS IR (ARBA) FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, YPAC LAROTREKTINIBO SULFATAS, ISKAITANT LAROTREKTINIBO VANDENILIO SULFATA; REGISTRATION NO/DATE: EU/1/19/1385 20190919
2132206	2022C/538	Belgium	⤷ Sign Up	PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217
1986495	122019000057	Germany	⤷ Sign Up	PRODUCT NAME: SEDAXANE ODER EIN TAUTOMER HIERVON MIT METALAXYL-M UND MIT FLUDIOXONIL; NAT. REGISTRATION NO/DATE: 008594-00 20181218; FIRST REGISTRATION: NIEDERLANDE 15544 N 20171229
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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