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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-eight approved drugs.

There are forty-five US patents protecting BAYER HLTHCARE drugs.

There are one thousand three hundred and forty-nine patent family members on BAYER HLTHCARE drugs in seventy-two countries and one hundred and ten supplementary protection certificates in sixteen countries.

Summary for Bayer Hlthcare

International Patents:	1349
US Patents:	45
Tradenames:	57
Ingredients:	38
NDAs:	58

Drugs and US Patents for Bayer Hlthcare

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Glossary

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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	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-003	Dec 26, 1990		DISCN	No	No		➤ Sign Up				➤ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-002	Dec 26, 1990		DISCN	Yes	No		➤ Sign Up				➤ Sign Up
Bayer Hlthcare	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	8,900,554	➤ Sign Up	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

Expired US Patents for Bayer Hlthcare

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MAGNEVIST	gadopentetate dimeglumine	INJECTABLE;INJECTION	021037-001	Mar 10, 2000	4,647,447	➤ Sign Up
Bayer Hlthcare	GADAVIST	gadobutrol	SOLUTION;INTRAVENOUS	201277-005	Mar 14, 2011	5,980,864	➤ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-001	Apr 8, 1996	5,286,754*PED	➤ Sign Up
Bayer Hlthcare	EOVIST	gadoxetate disodium	SOLUTION;INTRAVENOUS	022090-001	Jul 3, 2008	5,798,092	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for BAYER HLTHCARE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	3 mg/0.02 mg/0.451 mg and 0.451 mg	➤ Subscribe	2012-11-13
➤ Subscribe	Tablets	25 mg, 50 mg and 100 mg	➤ Subscribe	2005-03-22
➤ Subscribe	Tablets	200 mg	➤ Subscribe	2014-02-28
➤ Subscribe	Tablets	3 mg/0.02 mg	➤ Subscribe	2006-09-29
➤ Subscribe	Tablets	40 mg	➤ Subscribe	2016-09-27
➤ Subscribe	Transdermal System	0.05 mg/day and 0.1 mg/day	➤ Subscribe	2005-09-12
➤ Subscribe	Tablets	0.5 mg, 1 mg,1.5 mg, 2 mg and2.5 mg	➤ Subscribe	2017-10-10
➤ Subscribe	Tablets	5 mg ad 10 mg	➤ Subscribe	2009-07-10
➤ Subscribe	Oral Suspension	250 mg/5 mL and 500 mg/ 5 mL	➤ Subscribe	2009-10-16
➤ Subscribe	Gel	0.05%	➤ Subscribe	2010-12-01
➤ Subscribe	Orally Disintegrating Tablets	10 mg	➤ Subscribe	2011-12-22
➤ Subscribe	Tablets	3 mg/0.03 mg/0.451 mg and 0.451 mg	➤ Subscribe	2012-09-28
➤ Subscribe	Injection	1.6 mg/mL	➤ Subscribe	2014-02-07
➤ Subscribe	Tablets	0.5 mg/1 mg	➤ Subscribe	2007-12-26
➤ Subscribe	Tablets	0.25 mg/0.5 mg	➤ Subscribe	2015-01-08
➤ Subscribe	Tablets	3 mg/0.03 mg	➤ Subscribe	2005-01-07
➤ Subscribe	Topical Foam	15%	➤ Subscribe	2017-09-14
➤ Subscribe	Tablets	20 mg	➤ Subscribe	2009-03-05
➤ Subscribe	Tablets	2.5 mg	➤ Subscribe	2009-09-04
➤ Subscribe	Tablets	3 mg; 2 mg/2 mg; 2 mg/3 mg; 1 mg	➤ Subscribe	2010-10-22
➤ Subscribe	Tablets	3 mg/0.02 mg/0.451 mg and 0.451 mg	➤ Subscribe	2011-11-21
➤ Subscribe	Gel	15%	➤ Subscribe	2012-07-27

Premature patent expirations for BAYER HLTHCARE

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date
➤ Sign Up	➤ Sign Up

Non-Orange Book US Patents for Bayer Hlthcare

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
8,486,376	Moisturizing foam containing lanolin	➤ Sign Up
9,636,405	Foamable vehicle and pharmaceutical compositions thereof	➤ Sign Up
7,122,540	2-Phenyl substituted imidazotriazinones as phosphodiesterase inhibitors	➤ Sign Up
5,695,739	Derivatized DTPA complexes, pharmaceutical agents containing these compounds, their use, and processes for their production	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for Bayer Hlthcare Drugs

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Country	Document Number	Estimated Expiration
Portugal	1044975	➤ Sign Up
Cuba	23473	➤ Sign Up
China	102159160	➤ Sign Up
Estonia	04418	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for Bayer Hlthcare Drugs

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0034	France	➤ Sign Up	PRODUCT NAME: SORAFENIB TOSYLATE, ET AUTRES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE SORAFENIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/342/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/342/001 DU 20060719
00221	Netherlands	➤ Sign Up	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0242	Netherlands	➤ Sign Up
C/GB02/033	United Kingdom	➤ Sign Up	PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Similar Applicant Names

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

Summary for Bayer Hlthcare

Paragraph IV (Patent) Challenges for BAYER HLTHCARE drugs

Premature patent expirations for BAYER HLTHCARE

Expiration due to failure to pay maintenance fee

Similar Applicant Names

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