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Lupin Company Profile

LUPIN has two hundred approved drugs.

There are six US patents protecting LUPIN drugs. There are sixteen tentative approvals on LUPIN drugs.

There are ninety-six patent family members on LUPIN drugs in thirty-eight countries and three hundred and fourteen supplementary protection certificates in fifteen countries.

International Patents:	96
US Patents:	6
Tradenames:	161
Ingredients:	142
NDAs:	200
Patent Litigation for Lupin:	See patent lawsuits for Lupin
PTAB Cases with Lupin as petitioner:	See PTAB cases with Lupin 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
Lupin Ltd	CLONIDINE HYDROCHLORIDE	clonidine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209285-001	Oct 23, 2017	AB1	RX	No	No		See Pricing				See Pricing
Lupin Ltd	MEMANTINE HYDROCHLORIDE	memantine hydrochloride	TABLET;ORAL	090051-002	Apr 10, 2015	AB	RX	No	No		See Pricing				See Pricing
Lupin Ltd	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	210548-003	Jun 28, 2019	AB	RX	No	No		See Pricing				See Pricing
Lupin Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	078946-004	Mar 21, 2013	AB	RX	No	No		See Pricing				See Pricing
Lupin	TOPIRAMATE	topiramate	TABLET;ORAL	078410-004	Sep 11, 2013	AB	RX	No	No		See Pricing				See Pricing
Lupin Ltd	PAROXETINE HYDROCHLORIDE	paroxetine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204134-002	Jan 20, 2017	AB	RX	No	No		See Pricing				See Pricing
>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
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	4,800,079	See Pricing
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	4,800,079	See Pricing
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	4,800,079	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	for Injection	100 mcg/vial and 500 mcg/vial	➤ Subscribe	2015-04-14
➤ Subscribe	Delayed-release Tablets	20 mg	➤ Subscribe	2015-06-03
➤ Subscribe	for Injection	200 mcg/vial	➤ Subscribe	2015-05-01
➤ Subscribe	for Oral Suspension	500 mg/5 mL	➤ Subscribe	2014-07-22

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	2008/034	Ireland	See Pricing	PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
0253310	SZ 16/1996	Austria	See Pricing	PRODUCT NAME: LOSARTAN-KALIUM
1506211	122014000070	Germany	See Pricing	PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1467728	93074	Luxembourg	See Pricing	PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123
0268956	1999C0030	Belgium	See Pricing	PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0434450	1999C0033	Belgium	See Pricing	PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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