Bayer Company Profile

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What is the competitive landscape for BAYER

BAYER has one hundred and twenty-seven approved drugs.

There are seventy US patents protecting BAYER drugs. There is one tentative approval on BAYER drugs.

Summary for Bayer

US Patents:	70
Tradenames:	112
Ingredients:	76
NDAs:	127
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 Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes	10,047,097
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	10,835,515		Y
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-003	Mar 23, 1998	AB2	RX	Yes	No
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008		RX	Yes	Yes
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes	8,877,933		Y	Y
Bayer Pharms	AZLIN	azlocillin sodium	INJECTABLE;INJECTION	062388-001	Sep 8, 1982		DISCN	No	No

Expired US Patents for Bayer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982	3,839,573
Bayer Hlthcare	MYCELEX	clotrimazole	TROCHE/LOZENGE;ORAL	018713-001	Jun 17, 1983	3,660,577
Bayer Pharms	BAYCOL	cerivastatin sodium	TABLET;ORAL	020740-002	Jun 26, 1997	5,177,080
Bayer Hlthcare	LEVITRA	vardenafil hydrochloride	TABLET;ORAL	021400-003	Aug 19, 2003	7,696,206
Bayer Hlthcare	BILTRICIDE	praziquantel	TABLET;ORAL	018714-001	Dec 29, 1982	4,001,411
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021	9,919,050

Paragraph IV (Patent) Challenges for BAYER drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Bayer Drugs

Country	Patent Number	Estimated Expiration
Australia	2017246547
South Korea	20170116220
Cuba	20180125
Israel	181734
Hungary	E069657
Japan	6788649

Supplementary Protection Certificates for Bayer Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	C20200005 00308	Estonia		PRODUCT NAME: LAROTREKTINIIB;REG NO/DATE: EU/1/19/1385; 23.09.2019
1663978	1390050-1	Sweden		PRODUCT NAME: REGORAFENIB; PERIOD OF VALIDITY (FROM - UNTIL): 2024-07-23 - 2028-08-28
2782584	122021000080	Germany		PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; AUTHORISATION NO/DATE: 2205034.00.00 20210924; BE582231 20210406
2132206	PA2022512,C2132206	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	C202230028	Spain		PRODUCT NAME: FINERENONA Y SUS SALES, SOLVATOS Y SOLVATOS DE LAS SALES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1616; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1616; DATE OF FIRST AUTHORISATION IN EEA: 20220216
2132206	2290018-7	Sweden		PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. NO/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