BAYER HLTHCARE Company Profile

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BAYER HLTHCARE has fifty-six approved drugs.

There are thirty-seven US patents protecting BAYER HLTHCARE drugs.

There are eight hundred and seven patent family members on BAYER HLTHCARE drugs in fifty-eight countries and one hundred and forty-nine supplementary protection certificates in twenty countries.

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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	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	8,518,919	⤷ Subscribe				⤷ Subscribe
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003		DISCN	Yes	No	8,273,876	⤷ Subscribe				⤷ Subscribe
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	10,774,085	⤷ Subscribe				⤷ Subscribe
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990		DISCN	Yes	No		⤷ Subscribe				⤷ Subscribe
Bayer Hlthcare	XOFIGO	radium ra-223 dichloride	SOLUTION;INTRAVENOUS	203971-001	May 15, 2013		RX	Yes	Yes		⤷ Subscribe				⤷ Subscribe
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No	7,173,037	⤷ Subscribe	Y	Y		⤷ Subscribe
Bayer Hlthcare	STIVARGA	regorafenib	TABLET;ORAL	203085-001	Sep 27, 2012		RX	Yes	Yes	9,957,232	⤷ Subscribe		Y		⤷ Subscribe
>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	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-004	Oct 22, 1987	5,286,754*PED	⤷ Subscribe
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982	3,660,577	⤷ Subscribe
Bayer Hlthcare	KYLEENA	levonorgestrel	SYSTEM;INTRAUTERINE	208224-001	Sep 16, 2016	7,252,839	⤷ Subscribe
Bayer Hlthcare	BEYAZ	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022532-001	Sep 24, 2010	6,958,326	⤷ Subscribe
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	6,743,798	⤷ Subscribe
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004	4,364,921	⤷ Subscribe
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,441,168	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1140212	2014/033	Ireland	⤷ Subscribe	PRODUCT NAME: RADIUM-223 AND SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/873 20131113
3632448	22C1031	France	⤷ Subscribe	PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
1453521	C 2015 029	Romania	⤷ Subscribe	PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1506193	C300659	Netherlands	⤷ Subscribe	PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
0402407	97C0005	Belgium	⤷ Subscribe	PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1453521	39/2015	Austria	⤷ Subscribe	PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1429780	132013902137451	Italy	⤷ Subscribe	PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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