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Lupin Company Profile

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What is the competitive landscape for LUPIN, and when can generic versions of LUPIN drugs launch?

LUPIN has two hundred and fourteen approved drugs.

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

There are twenty patent family members on LUPIN drugs in seven countries and four hundred and fifteen supplementary protection certificates in sixteen countries.

Summary for Lupin

International Patents:	20
US Patents:	10
Tradenames:	173
Ingredients:	154
NDAs:	214
Patent Litigation for Lupin:	See patent lawsuits for Lupin
PTAB Cases with Lupin as petitioner:	See PTAB cases with Lupin as petitioner

Drugs and US Patents for Lupin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	DESOXIMETASONE	desoximetasone	CREAM;TOPICAL	208163-001	Jan 10, 2017	AB	RX	No	No
Lupin	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090245-004	Mar 30, 2015	AB	RX	No	No
Lupin Ltd	DICLOFENAC SODIUM	diclofenac sodium	SOLUTION;TOPICAL	204132-001	Aug 20, 2015	AT	RX	No	No
Lupin	LISINOPRIL	lisinopril	TABLET;ORAL	077321-006	Sep 9, 2005	AB	RX	No	No
Lupin Ltd	NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	090860-001	Mar 20, 2014	AB	RX	No	No

Expired US Patents for Lupin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	4,800,079
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	7,101,574
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004	7,863,331
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-003	Nov 30, 2004	4,800,079
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	7,101,574

Paragraph IV (Patent) Challenges for LUPIN drugs

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

International Patents for Lupin Drugs

Country	Patent Number	Estimated Expiration
Japan	2021042246
South Korea	20200083958
World Intellectual Property Organization (WIPO)	2014091318
Australia	2018203882
Japan	2020019759

Supplementary Protection Certificates for Lupin Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0350733	2001C/030	Belgium		PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
0454511	SPC/GB98/037	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE) (GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1534313	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Lupin
• Lupin Atlantis
• Lupin Ltd
• Lupin Pharms