Cheplapharm Company Profile

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CHEPLAPHARM has fourteen 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 thirty-six 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	ZYPREXA	olanzapine	TABLET;ORAL	020592-005	Sep 9, 1997	AB	RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-002	Jul 12, 2006		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Cheplapharm	KLONOPIN	clonazepam	TABLET;ORAL	017533-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Cheplapharm	PULMICORT FLEXHALER	budesonide	POWDER, METERED;INHALATION	021949-001	Jul 12, 2006		RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-002	Dec 11, 2009		RX	Yes	No		⤷ Sign Up				⤷ Sign Up
>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	020592-006	Sep 9, 1997	5,229,382*PED	⤷ Sign Up
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	5,817,655	⤷ Sign Up
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-002	Apr 6, 2000	5,457,895	⤷ Sign Up
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996	5,736,541*PED	⤷ Sign Up
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	5,627,178*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	132021000000095	Italy	⤷ Sign Up	PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
1304992	PA2013025	Lithuania	⤷ Sign Up	PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
0617614	2001/009	Ireland	⤷ Sign Up	PRODUCT NAME: PANRETIN-ALITRETINOIN
1304992	C300617	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	92401	Luxembourg	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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