Lupin Company Profile

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

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.

Summary for Lupin

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

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	ROSUVASTATIN CALCIUM	rosuvastatin calcium	TABLET;ORAL	205587-001	Jul 31, 2017	AB	RX	No	No
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes	11,684,607		Y
Lupin Ltd	LEVETIRACETAM	levetiracetam	TABLET, EXTENDED RELEASE;ORAL	091399-001	Sep 12, 2011	AB	RX	No	No
Lupin	SOLOSEC	secnidazole	GRANULE;ORAL	209363-001	Sep 15, 2017		RX	Yes	Yes
Lupin Pharms	RIFAMPIN	rifampin	CAPSULE;ORAL	090034-001	Aug 21, 2013	AB	RX	No	No
Lupin Ltd	BRIVARACETAM	brivaracetam	TABLET;ORAL	214918-002	Dec 20, 2022		DISCN	No	No
Lupin Ltd	LEFLUNOMIDE	leflunomide	TABLET;ORAL	211863-001	Feb 4, 2020	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	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,605,674
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,866,839
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,814,953
Lupin	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	7,863,331
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005	5,439,670
Lupin	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
	Injection	250 mcg/0.5 mL, 1 mL PFS		2012-03-30
	Inhalation Solution	Eq. 0.015 mg base/2 mL		2009-10-01
	for Injection	200 mcg/vial		2015-05-01
	for Oral Suspension	500 mg/5 mL		2014-07-22
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14

International Patents for Lupin Drugs

Country	Patent Number	Estimated Expiration
Canada	2865950
Japan	2021042246
Japan	2018048350
Australia	2013226073
Mexico	353603
Poland	212725
South Korea	20170052626

Supplementary Protection Certificates for Lupin Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3150586	18/2020	Austria		PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925
1261586	132012902044560	Italy		PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0443983	C00443983/02	Switzerland		PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
0600675	SPC/GB10/031	United Kingdom		PRODUCT NAME: SILODOSIN, OPTIONALLY IN A FORM OF A PHARMACEUTICAL ACCEPTABLE SALT; REGISTERED: UK EU/1/09/607/001-014 20100129; UK EU/1/09/608/001-014 20100129
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
2487166	2017003	Norway		PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV OG TENOFOVIR ALAFENAMID ELLER FARMASOEYTISK AKSEPTABELT SALT DERAV, SPESIELT TENOFOVIR ALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061 20151209

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