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Lupin Company Profile

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What is the competitive landscape for LUPIN, and what generic alternatives to LUPIN drugs are available?

LUPIN has one hundred and seventy-six approved drugs.

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

There are eighty-six patent family members on LUPIN drugs in thirty-eight countries and two hundred and fifty-four supplementary protection certificates in fourteen countries.

Summary for Lupin

International Patents:	86
US Patents:	5
Tradenames:	141
Ingredients:	122
NDAs:	176
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	QUINAPRIL HYDROCHLORIDE	quinapril hydrochloride	TABLET;ORAL	077690-004	Jun 20, 2006	AB	RX	No	No
Lupin Ltd	DOXERCALCIFEROL	doxercalciferol	INJECTABLE;INJECTION	210801-001	Nov 1, 2018	AP	RX	No	No
Lupin Ltd	LOSARTAN POTASSIUM	losartan potassium	TABLET;ORAL	078232-001	Oct 6, 2010	AB	RX	No	No
Lupin Pharms	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	077560-003	Mar 2, 2012	AB	RX	No	No

Expired US Patents for Lupin

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

Paragraph IV (Patent) Challenges for LUPIN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	20 mg		2015-06-03
	for Oral Suspension	500 mg/5 mL		2014-07-22

International Patents for Lupin Drugs

Country	Patent Number	Estimated Expiration
Israel	174660
Slovakia	152002
Eurasian Patent Organization	004294
China	1360499

Supplementary Protection Certificates for Lupin Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
0454511	98C0028	Belgium		PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
1732523	300925	Netherlands		PRODUCT NAME: PATIROMER SORBITEX CALCIUM EN ALLE ZOUTEN DAARVAN
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215

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