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	LEVLITE	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	020860-001	Jul 13, 1998		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010		RX	Yes	Yes	8,153,616	⤷ 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 Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	9,782,414	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-002	Jun 17, 2021		OTC	Yes	Yes	8,518,919	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	MYCELEX	clotrimazole	SOLUTION;TOPICAL	018181-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	10,799,505	⤷ Sign Up	Y	Y		⤷ 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	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	5,980,864	⤷ Sign Up
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	6,441,168	⤷ Sign Up
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995	4,364,921	⤷ Sign Up
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	7,235,576	⤷ Sign Up
Bayer Hlthcare	NATAZIA	dienogest; estradiol valerate	TABLET;ORAL	022252-001	May 6, 2010	6,133,251	⤷ Sign Up
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003	7,696,206	⤷ Sign Up
Bayer Hlthcare	SAFYRAL	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	022574-001	Dec 16, 2010	5,798,338	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Tablets	3 mg/0.02 mg	➤ Subscribe	2006-09-29
➤ Subscribe	Injection	1.6 mg/mL	➤ Subscribe	2014-02-07

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0771217	07C0001	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1519731	C300740	Netherlands	⤷ Sign Up	PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1214076	SZ 49/2008	Austria	⤷ Sign Up	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1506193	S1400019	Hungary	⤷ Sign Up	PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327
1140212	C300666	Netherlands	⤷ Sign Up	PRODUCT NAME: RADIUM-223, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/13/873/001 20131113
0780390	PA2004012	Lithuania	⤷ Sign Up	PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-__ 1,4-DIHIDRO-8-METOKSI-7-[(4AS, 7AS)-OKTAHIDRO-6H-PIROLO[3,4-B]PIRIDIN_-6-IL]-4-OKSO-3-CHINOLINKARBOKSIRÃ»GÃ°TIES HIDROCHLORIDAS)
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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