BAYER Company Profile

What is the competitive landscape for BAYER, and what generic alternatives to BAYER drugs are available?

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 four patent family members on BAYER drugs in sixty countries and one hundred and ninety-eight supplementary protection certificates in twenty countries.

Summary for BAYER

International Patents:	1104
US Patents:	54
Tradenames:	109
Ingredients:	73
NDAs:	124
Patent Litigation for BAYER:	See patent lawsuits for BAYER

Drugs and US Patents for BAYER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	9,127,013		Y	Y
Bayer Healthcare Llc	GYNE-LOTRIMIN 3	clotrimazole	TABLET;VAGINAL	020525-001	Jul 29, 1996		DISCN	Yes	No
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	9,676,783
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-006	Dec 18, 2013	AP	RX	Yes	Yes
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes
Bayer Pharms	MEZLIN	mezlocillin sodium monohydrate	INJECTABLE;INJECTION	050549-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No	9,676,783

Expired US Patents for BAYER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-001	Aug 19, 2003	7,696,206
Bayer Hlthcare	YASMIN	drospirenone; ethinyl estradiol	TABLET;ORAL-28	021098-001	May 11, 2001	5,569,652
Bayer Hlthcare	YAZ	drospirenone; ethinyl estradiol	TABLET;ORAL	021676-001	Mar 16, 2006	5,569,652
Bayer Pharms	MYCELEX-G	clotrimazole	TABLET;VAGINAL	019069-001	Apr 19, 1985	3,660,577
Bayer Hlthcare	CLIMARA PRO	estradiol; levonorgestrel	FILM, EXTENDED RELEASE;TRANSDERMAL	021258-001	Nov 21, 2003	5,252,334
Bayer Hlthcare	KYLEENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	208224-001	Sep 16, 2016	7,252,839
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	8,187,632*PED

Paragraph IV (Patent) Challenges for BAYER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for BAYER Drugs

Country	Patent Number	Estimated Expiration
Hong Kong	1155351
South Korea	20140129384
Russian Federation	2417590
Cyprus	1120260
Chile	2015002304
Honduras	2006009000
China	102210689

Supplementary Protection Certificates for BAYER Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1140840	SPC/GB07/004	United Kingdom		PRODUCT NAME: SORAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/06/342/001 20060721
2097381	C02097381/01	Switzerland		PRODUCT NAME: REGORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62808 15.03.2018
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2132206	2022C/538	Belgium		PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217

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