Lupin Company Profile

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LUPIN has two hundred and forty-four approved drugs.

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

There are eighty-three patent family members on LUPIN drugs in twenty-four countries and seven hundred and thirty-two supplementary protection certificates in seventeen countries.

International Patents:	83
US Patents:	9
Tradenames:	199
Ingredients:	179
NDAs:	244
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	AMABELZ	estradiol; norethindrone acetate	TABLET;ORAL	203339-002	Jun 20, 2016	BX	RX	No	No		⤷ Sign Up				⤷ Sign Up
Lupin	LEVOTHYROXINE SODIUM	levothyroxine sodium	TABLET;ORAL	209713-005	Jan 18, 2019	AB1,AB2,AB3	RX	No	No		⤷ Sign Up				⤷ Sign Up
Lupin	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	205587-001	Jul 31, 2017	AB	RX	No	No		⤷ Sign Up				⤷ Sign Up
Lupin Ltd	GLYCOPYRROLATE	glycopyrrolate	INJECTABLE;INJECTION	213655-001	Feb 7, 2023		DISCN	No	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
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	7,863,331	⤷ Sign Up
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	8,765,153	⤷ Sign Up
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,541,385	⤷ Sign Up
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	7,256,310	⤷ Sign Up
>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
0817637	23/2005	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
1441735	08C0026	France	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1915993	92315	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
1638574	C 2017 049	Romania	⤷ Sign Up	PRODUCT NAME: MIDOSTAURINA SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1218; DATE OF NATIONAL AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1218; DATE OF FIRST AUTHORISATION IN EEA: 20170918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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