Dexcel Company Profile

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DEXCEL has seventeen approved drugs.

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

There are thirteen patent family members on DEXCEL drugs in six countries and fifty-nine supplementary protection certificates in sixteen countries.

International Patents:	13
US Patents:	7
Tradenames:	14
Ingredients:	14
NDAs:	17
Patent Litigation for Dexcel:	See patent lawsuits for Dexcel

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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
Dexcel	HEMADY	dexamethasone	TABLET;ORAL	211379-001	Oct 3, 2019		RX	Yes	Yes	11,304,961	⤷ Start Trial	Y			⤷ Start Trial
Dexcel Ltd	DICLOFENAC SODIUM	diclofenac sodium	TABLET, EXTENDED RELEASE;ORAL	076201-001	Nov 6, 2002	AB	RX	No	Yes		⤷ Start Trial				⤷ Start Trial
Dexcel	PANTOPRAZOLE SODIUM	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	216247-001	Jun 16, 2023	AB	RX	No	No		⤷ Start Trial				⤷ Start Trial
Dexcel	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209193-002	Oct 31, 2019	AB	RX	No	No		⤷ Start Trial				⤷ Start Trial
Dexcel	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209193-001	Oct 31, 2019	AB	RX	No	No		⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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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	⤷ Start Trial
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998	5,023,082	⤷ Start Trial
Dexcel Pharma	PERIOCHIP	chlorhexidine gluconate	TABLET;DENTAL	020774-001	May 15, 1998	5,002,769	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Estimated Expiration
Israel	255048	⤷ Start Trial
European Patent Office	3932396	⤷ Start Trial
Australia	2017285390	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2019123453	⤷ Start Trial
Spain	2552723	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1830843	132016000021977	Italy	⤷ Start Trial	PRODUCT NAME: NINTEDANIB, SUOI TAUTOMERI, O LORO MISCELE O I SUOI SALI, IN PARTICOLARE ESILATO DI NINTEDANIB(OFEV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/979, 20150119
1666481	PA2017025,C1666481	Lithuania	⤷ Start Trial	PRODUCT NAME: TOFACITINIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALE, ISKAITANT CITRATO DRUSKAAA; REGISTRATION NO/DATE: EU/1/17/1178 20170322
1129088	2014/008	Ireland	⤷ Start Trial	PRODUCT NAME: DEXLANSOPRAZOLE OR A SALT THEREOF; NAT REGISTRATION NO/DATE: PA1864/001/001-002;PA1864/002/001-002 20131125; FIRST REGISTRATION NO/DATE: 47911 47912 47913 47914 20130919
1666481	LUC00031	Luxembourg	⤷ Start Trial	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
1224170	17/2015	Austria	⤷ Start Trial	PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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