Bayer Healthcare Company Profile

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

BAYER HEALTHCARE has twenty-nine approved drugs.

There are twenty-six US patents protecting BAYER HEALTHCARE drugs. There is one tentative approval on BAYER HEALTHCARE drugs.

There are four hundred and ten patent family members on BAYER HEALTHCARE drugs in fifty-eight countries and forty-seven supplementary protection certificates in seventeen countries.

Summary for Bayer Healthcare

International Patents:	410
US Patents:	26
Tradenames:	24
Ingredients:	14
NDAs:	29
Patent Litigation for Bayer Healthcare:	See patent lawsuits for Bayer Healthcare

Drugs and US Patents for Bayer Healthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	GYNE-LOTRIMIN 3 COMBINATION PACK	clotrimazole	CREAM, TABLET;TOPICAL, VAGINAL	020526-002	Jul 29, 1996		DISCN	Yes	No
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	11,168,058		Y	Y
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	9,447,104
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes	10,137,127		Y
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	SYRUP;ORAL	020641-003	Nov 19, 2003		DISCN	Yes	No

Expired US Patents for Bayer Healthcare

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	SHADE UVAGUARD	avobenzone; octinoxate; oxybenzone	LOTION;TOPICAL	020045-001	Dec 7, 1992	4,522,807
Bayer Healthcare Llc	MYCELEX	clotrimazole	CREAM;TOPICAL	018183-001	Approved Prior to Jan 1, 1982	3,660,577
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002	4,863,931*PED
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002	4,863,931*PED

International Patents for Bayer Healthcare Drugs

Country	Patent Number	Estimated Expiration
Spain	2588504
Croatia	P20131159
Chile	2017001249
Cyprus	1109790
Russian Federation	2751636
Taiwan	201249847

Supplementary Protection Certificates for Bayer Healthcare Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
2493858	C02493858/01	Switzerland		PRODUCT NAME: DAROLUTAMIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67521 19.06.2020
3106463	2090009-8	Sweden		PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923
2493858	301041	Netherlands		PRODUCT NAME: DAROLUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBARE ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1432 20200330
3106463	132020000000025	Italy		PRODUCT NAME: LAROTRECTINIB E/O SUOI SALI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE LAROTRECTINIB SOLFATO INCLUSO LAROTRECTINIB IDROGENO SOLFATO(VITRAKVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1385, 20190923
3106463	2020C/507	Belgium		PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923

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