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Cipla Company Profile

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CIPLA has ninety-three approved drugs.

There are four US patents protecting CIPLA drugs. There are thirty-two tentative approvals on CIPLA drugs.

There are twenty-three patent family members on CIPLA drugs in twenty-one countries and three hundred and thirty-seven supplementary protection certificates in sixteen countries.

International Patents:	23
US Patents:	4
Tradenames:	82
Ingredients:	82
NDAs:	93
Patent Litigation for Cipla:	See patent lawsuits for Cipla
PTAB Cases with Cipla as petitioner:	See PTAB cases with Cipla as petitioner

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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
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303-001	Jun 25, 2018		RX	Yes	Yes	8,822,424	Start Trial	Y			Start Trial
Cipla Ltd	IRINOTECAN HYDROCHLORIDE	irinotecan hydrochloride	INJECTABLE;INJECTION	077219-001	Feb 20, 2008	AP	RX	No	No		Start Trial				Start Trial
Cipla	LAMOTRIGINE	lamotrigine	TABLET;ORAL	077783-001	Nov 1, 2010	AB	RX	No	No		Start Trial				Start Trial
Cipla	PREGABALIN	pregabalin	CAPSULE;ORAL	212280-008	Jan 10, 2020	AB	RX	No	No		Start Trial				Start Trial
Cipla	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206046-001	Jul 26, 2017		DISCN	No	No		Start Trial				Start Trial
Cipla	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	208915-001	Mar 8, 2018	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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Country	Patent Number	Estimated Expiration
Japan	2011504508	Start Trial
World Intellectual Property Organization (WIPO)	2009067692	Start Trial
China	101868472	Start Trial
Portugal	2217610	Start Trial
Brazil	PI0819319	Start Trial
Japan	4986310	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0265685	SPC/GB98/047	United Kingdom	Start Trial	PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
1499331	SPC/GB13/034	United Kingdom	Start Trial	PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0434450	1999C0033	Belgium	Start Trial	PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
0058146	2001C/045	Belgium	Start Trial	PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103
1301519	C01301519/01	Switzerland	Start Trial	PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
1591122	132013902140458	Italy	Start Trial	PRODUCT NAME: ACIDO ZOLEDRONICO(ACLASTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/308/002, 20071003;57363, 20070927
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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