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-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-seven supplementary protection certificates in twenty countries.

Summary for Bayer Hlthcare

International Patents:	807
US Patents:	37
Tradenames:	57
Ingredients:	37
NDAs:	56

Drugs and US Patents for Bayer Hlthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	10,813,936
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No	10,662,188		Y	Y
Bayer Hlthcare	ANGIOVIST 292	diatrizoate meglumine; diatrizoate sodium	INJECTABLE;INJECTION	087724-001	Sep 23, 1982		DISCN	No	No
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003	AB2	RX	Yes	No
Bayer Hlthcare	UROVIST CYSTO	diatrizoate meglumine	SOLUTION;URETERAL	087729-001	Sep 23, 1982		DISCN	No	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No	10,662,188		Y	Y
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003		DISCN	No	No

Expired US Patents for Bayer Hlthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999	5,849,752
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003	5,676,968
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-002	Mar 14, 2011	5,980,864
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	RE43916
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	8,187,632*PED
Bayer Hlthcare	STAXYN	vardenafil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	200179-001	Jun 17, 2010	6,362,178
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-002	Aug 19, 2003	7,696,206

Paragraph IV (Patent) Challenges for BAYER HLTHCARE drugs

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

International Patents for Bayer Hlthcare Drugs

Country	Patent Number	Estimated Expiration
Australia	2017268517
China	102198140
Taiwan	I324928
Taiwan	200700093
Taiwan	201204356
Israel	181734
Austria	E424828

Supplementary Protection Certificates for Bayer Hlthcare Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0350733	C300111	Netherlands		PRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; FIRST REGISTRATION: DE 45263.00.00 19990621
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
3106463	301033	Netherlands		PRODUCT NAME: LAROTRECTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LAROTRECTINIBSULFAAT, MET INBEGRIP VAN LAROTRECTINIBSULFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
1506193	CR 2014 00028	Denmark		PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327
0780390	PA2004012	Lithuania		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-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS)
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1663978	C 2014 007	Romania		PRODUCT NAME: REGORAFENIB SI SARURILE SALE4-[4-({[4-CLORO-3-(TRIFLUOROMETIL)-FENIL]CARBAMOIL}AMINO)-TIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/858; DATE OF FIRST AUTHORISATION IN EEA: 20130826 3-FLUOROFENOXI]-N-METILPIRIDIN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/13/858; DATE OF NA

Similar Applicant Names

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

• Bayer
• Bayer Healthcare
• Bayer Healthcare Llc
• Bayer Hlthcare
• Bayer Pharms