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	DROXIA	hydroxyurea	CAPSULE;ORAL	016295-004	Feb 25, 1998		RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	VESANOID	tretinoin	CAPSULE;ORAL	020438-001	Nov 22, 1995		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-001	Apr 6, 2000	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	AB	RX	Yes	No		⤷ 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	ZYPREXA	olanzapine	TABLET;ORAL	020592-005	Sep 9, 1997	AB	RX	Yes	No		⤷ 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	020592-004	Sep 30, 1996	6,960,577	⤷ Try a Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996	5,736,541*PED	⤷ Try a Trial
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	6,251,895	⤷ Try a Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	6,251,895*PED	⤷ Try a Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	5,817,655*PED	⤷ Try a Trial
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-004	Apr 6, 2000	5,817,656	⤷ 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
0316704	SPC/GB01/015	United Kingdom	⤷ Try a Trial	PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202
0316704	2001C/021	Belgium	⤷ Try a Trial	PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
1304992	CR 2013 00053	Denmark	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
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
1304992	122013000081	Germany	⤷ Try a Trial	PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
0129748	98C0042	Belgium	⤷ Try a Trial	PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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