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Lilly Company Profile

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

LILLY has one hundred and eight approved drugs.

There are two US patents protecting LILLY drugs.

There are forty-five patent family members on LILLY drugs in twenty-seven countries and eighty-two supplementary protection certificates in thirteen countries.

Summary for Lilly

International Patents:	45
US Patents:	2
Tradenames:	87
Ingredients:	82
NDAs:	108

Drugs and US Patents for Lilly

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003	AB	RX	Yes	Yes
Lilly	SECONAL SODIUM	secobarbital sodium	SUPPOSITORY;RECTAL	086530-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001		DISCN	Yes	No
Lilly	TAZIDIME IN PLASTIC CONTAINER	ceftazidime	INJECTABLE;INJECTION	062739-001	Jul 10, 1986		DISCN	No	No

Expired US Patents for Lilly

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	5,859,006*PED
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	4,314,081*PED
Lilly	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	5,605,897*PED
Lilly	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996	5,736,541*PED

Paragraph IV (Patent) Challenges for LILLY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Capsules	40 mg		2012-05-10
	Capsules	6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg		2005-01-10
	For Injection	200 mg/vial		2005-11-01
	For Injection	2 g/vial		2007-08-24
	For Injection	500 mg/vial		2008-02-04
	For Injection	750 mg/vial		2016-10-06
	Tablets	2.5 mg		2008-10-14
	Delayed-release Capsules	20 mg, 30 mg and 60 mg		2008-08-04
	Capsules	10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg		2007-05-29
	Capsules	3 mg/25 mg		2008-05-08
	For Injection	1g/vial		2005-11-14
	For Injection	100 mg/vial		2008-07-01
	For Injection	1000 mg/vial		2012-06-27
	Injection	250 mcg/mL, 2.4 mL prefilled Pen		2015-07-27
	Tablets	5 mg, 10 mg and 20 mg		2007-11-21

International Patents for Lilly Drugs

Country	Patent Number	Estimated Expiration
Montenegro	03411
Brazil	PI0509269
Spain	2728788
South Korea	20060131946

Supplementary Protection Certificates for Lilly Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273658	2005C/001	Belgium		PRODUCT NAME: CHLORHYDRATE DE DULOXETINE; REGISTRATION NO/DATE: EU/1/04/280/001 20040811
0122707	96C0030	Belgium		PRODUCT NAME: CHLORHYDRATE DE GEMCITABINE EQUIVALENT EN GEMCITABINE; NAT. REGISTRATION NO/DATE: 58 IS 88 F 12 19960606; FIRST REGISTRATION: NL RVG 17854 19950327
0740668	PA2003001,C0740668	Lithuania		PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
0454436	C970015	Netherlands		PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927

Similar Applicant Names

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

• Lilly
• Lilly Res Labs