Cheplapharm Company Profile

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CHEPLAPHARM has thirteen approved drugs.

There are two US patents protecting CHEPLAPHARM drugs.

There are thirty-two patent family members on CHEPLAPHARM drugs in thirty-one countries and twenty-eight supplementary protection certificates in thirteen countries.

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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
Cheplapharm	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes	9,642,911	⤷ Try a Trial	Y			⤷ Try a Trial
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-003	Dec 11, 2009		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a 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
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996	5,919,485*PED	⤷ Try a Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-005	Sep 9, 1997	5,627,178*PED	⤷ Try a Trial
Cheplapharm	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	INJECTABLE;INJECTION	020457-001	May 17, 1996	5,041,424	⤷ Try a Trial
Cheplapharm	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	6,083,953*PED	⤷ Try a Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	5,736,541*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	450 mg	➤ Subscribe	2005-12-27
➤ Subscribe	Tablets	150 mg and 500 mg	➤ Subscribe	2008-11-10
➤ Subscribe	For Oral Solution	50 mg/mL	➤ Subscribe	2011-03-21

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	SPC/GB96/058	United Kingdom	⤷ Try a Trial	PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927
1304992	92401	Luxembourg	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
0694547	2002/028	Ireland	⤷ Try a Trial	PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
0454436	C970015	Netherlands	⤷ Try a Trial	PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0617614	C300043	Netherlands	⤷ Try a Trial	PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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