BAYER Company Profile

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BAYER has one hundred and twenty-four approved drugs.

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

There are one thousand three hundred and twenty-one patent family members on BAYER drugs in sixty-six countries and one hundred and ninety-seven supplementary protection certificates in twenty countries.

International Patents:	1321
US Patents:	58
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 Healthcare Llc	OCUCLEAR	oxymetazoline hydrochloride	SOLUTION/DROPS;OPHTHALMIC	018471-001	May 30, 1986		DISCN	No	No		See Plans and Pricing				See Plans and Pricing
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No		See Plans and Pricing				See Plans and Pricing
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No	10,662,188	See Plans and Pricing	Y	Y		See Plans and Pricing
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	9,447,104	See Plans and Pricing				See Plans and Pricing
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005		RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Bayer Hlthcare	QUINACT	quinidine gluconate	TABLET;ORAL	085978-001	Approved Prior to Jan 1, 1982		DISCN	No	No		See Plans and Pricing				See Plans and Pricing
>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	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE38253	See Plans and Pricing
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	6,933,395	See Plans and Pricing
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	RE37564	See Plans and Pricing
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003	7,696,206	See Plans and Pricing
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985	3,644,627	See Plans and Pricing
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997	6,136,347*PED	See Plans and Pricing
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	5,286,754*PED	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	92419	Luxembourg	See Plans and Pricing	PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
1453521	93156	Luxembourg	See Plans and Pricing	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076	49/2008	Austria	See Plans and Pricing	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0984957	CR 2012 00035	Denmark	See Plans and Pricing	PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
1539166	2013C/064	Belgium	See Plans and Pricing	PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1140840	SZ 35/2006	Austria	See Plans and Pricing	PRODUCT NAME: SORAFENIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE HIERVON
1140212	CA 2014 00027	Denmark	See Plans and Pricing	PRODUCT NAME: RADIUM-223 OG OPLOESELIGE SALTE DERAF, HERUNDER RADIUM-223 DICHLORID; REG. NO/DATE: EU/1/13/873 20131113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.