LUPIN Company Profile

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LUPIN has two hundred and thirty-one approved drugs.

There are nineteen US patents protecting LUPIN drugs. There are twenty-two tentative approvals on LUPIN drugs.

There are ninety-nine patent family members on LUPIN drugs in twenty-four countries and six hundred and seventy-eight supplementary protection certificates in seventeen countries.

International Patents:	99
US Patents:	19
Tradenames:	189
Ingredients:	169
NDAs:	231
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 Pharms	DROXIDOPA	droxidopa	CAPSULE;ORAL	211652-001	Feb 18, 2021	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	DIVALPROEX SODIUM	divalproex sodium	TABLET, EXTENDED RELEASE;ORAL	209286-001	Oct 18, 2019	AB	RX	No	No		⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	200797-005	Jun 3, 2015	AB	RX	No	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
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,439,670	⤷ Try a Trial
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,547,994	⤷ Try a Trial
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	4,800,079	⤷ Try a Trial
>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	Injection	250 mcg/0.5 mL, 1 mL PFS	➤ Subscribe	2012-03-30
➤ Subscribe	Inhalation Solution	Eq. 0.015 mg base/2 mL	➤ Subscribe	2009-10-01
➤ 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
1559427	C 2013 020	Romania	⤷ Try a Trial	PRODUCT NAME: MIRABEGRON SAU O SARE A ACESTUIA(2-(2-AMINO-1,3-TRIAZOL-4-IL)-N-[4-(2-{[(2R)-2-HIDROXI9/014; DATE OF NATIONAL AUTHORISATION: 20121220; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/809/001 - EU/1/12/809/014; DATE OF FIRST AUTHORISATION IN EEA: 20121220 -2-FENILETIL]AMINO}ETIL)FENIL]ACETAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/12/809/001 - EU/1/12/80
0600675	1090028-0.L	Sweden	⤷ Try a Trial	PRODUCT NAME: SILODOSIN ELLER FARMACEUTISKA GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/09/607/001-014 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-01-29" SEGODKNR="EU/1/09/607/001-014 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-01-29" FLAG="L" SPCNR="1090028-0" 20100129
1467728	CA 2016 00022	Denmark	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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