Chattem Company Profile

What is the competitive landscape for CHATTEM

CHATTEM has twenty approved drugs.

There are two US patents protecting CHATTEM drugs.

There are sixty-seven patent family members on CHATTEM drugs in forty countries and six supplementary protection certificates in four countries.

Summary for Chattem

International Patents:	67
US Patents:	2
Tradenames:	17
Ingredients:	9
NDAs:	20

Drugs and US Patents for Chattem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	ZANTAC 75	ranitidine hydrochloride	TABLET;ORAL	020520-001	Dec 19, 1995		DISCN	Yes	No
Chattem Sanofi	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-006	Jan 24, 2011		DISCN	Yes	No
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011		OTC	Yes	Yes
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011		OTC	Yes	Yes
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011		OTC	Yes	Yes
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	SOLUTION;ORAL	209090-001	Jan 31, 2017		OTC	Yes	Yes	8,633,194		Y
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011		DISCN	Yes	No

Expired US Patents for Chattem

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011	6,187,791
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	9,205,059
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	8,663,680
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-004	Aug 2, 1996	6,165,497
Chattem Sanofi	NICODERM CQ	nicotine	FILM, EXTENDED RELEASE;TRANSDERMAL	020165-006	Aug 2, 1996	5,364,630
Chattem Sanofi	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011	5,578,610
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011	6,613,357

Paragraph IV (Patent) Challenges for CHATTEM drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Oral Suspension	30 mg/5 mL		2010-01-25
	Oral Solution	0.5 mg/mL		2009-01-14
	Tablets	150 mg		2007-10-30
	Transdermal System	7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs		2014-05-30
	Tablets	5 mg		2007-12-17

International Patents for Chattem Drugs

Country	Patent Number	Estimated Expiration
Taiwan	200605892
Norway	337768
Uruguay	30021
South Korea	20070043841
Hong Kong	1103958
Spain	2332462
Egypt	25866

Supplementary Protection Certificates for Chattem Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663828	C300085	Netherlands		PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
3185856	CA 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	LUC00356	Luxembourg		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 2024030081 20240220
3185856	2024C/535	Belgium		PRODUCT NAME: COMBINATIE VAN DOXYLAMINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN PYRIDOXINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE662396 20240321
3185856	CR 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
0058146	2001C/045	Belgium		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103

Similar Applicant Names

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

• Chattem
• Chattem Sanofi