Dexcel Company Profile

What is the competitive landscape for DEXCEL

DEXCEL has seventeen approved drugs.

There are seven US patents protecting DEXCEL drugs. There is one tentative approval on DEXCEL drugs.

Summary for Dexcel

US Patents:	7
Tradenames:	14
Ingredients:	14
NDAs:	17
Patent Litigation for Dexcel:	See patent lawsuits for Dexcel

Drugs and US Patents for Dexcel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dexcel	OMEPRAZOLE	omeprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	209400-001	Jul 5, 2017		OTC	Yes	Yes	10,835,488		Y
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes
Dexcel	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209193-001	Oct 31, 2019	AB	RX	No	No
Dexcel	ESOMEPRAZOLE MAGNESIUM	esomeprazole magnesium	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	214278-001	Oct 20, 2020		DISCN	Yes	No	10,835,488		Y
Dexcel	NINTEDANIB ESYLATE	nintedanib esylate	CAPSULE;ORAL	219819-001	Apr 2, 2026	AB	RX	No	No
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes	10,537,585		Y
Dexcel	OMEPRAZOLE	omeprazole	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	209400-001	Jul 5, 2017		OTC	Yes	Yes	10,076,494		Y

Expired US Patents for Dexcel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dexcel Pharma	OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032-001	Dec 4, 2007	9,023,391
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998	5,023,082
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998	5,002,769

Paragraph IV (Patent) Challenges for DEXCEL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	20 mg		2015-06-03

International Patents for Dexcel Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009136398
World Intellectual Property Organization (WIPO)	2019123453
World Intellectual Property Organization (WIPO)	2016174664
Hong Kong	1156209
European Patent Office	3288556
Israel	208925
Australia	2017285390

Supplementary Protection Certificates for Dexcel Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1666481	122017000062	Germany		PRODUCT NAME: TOFACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1666481	LUC00031	Luxembourg		PRODUCT NAME: TOFACITINIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL DE CITRATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1830843	41/2015	Austria		PRODUCT NAME: NINTEDANIB, ODER EIN TAUTOMER, EINE MISCHUNG HIEVON ODER EIN SALZ HIEVON; INBESONDERE NINTEDANIB ESILATE.; REGISTRATION NO/DATE: EU/1/14/979 20150119
1830843	C 2015 026	Romania		PRODUCT NAME: NINTEDANIB SAU UN TAUTOMER SAU AMESTECURI ALE ACESTORA SAU O SARE A ACESTORA, IN SPECIAL ESILAT DE NINTEDANIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/979/001-004; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/979/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20150115
0296560	2/1998	Austria		PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
1666481	2017C/032	Belgium		PRODUCT NAME: TOFACITINIB; AUTHORISATION NUMBER AND DATE: EU/1/17/1178 20170324
1224170	PA2015015,C1224170	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121

Similar Applicant Names

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

• Dexcel
• Dexcel Ltd
• Dexcel Pharma