Lilly Company Profile

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

LILLY has one hundred and five approved drugs.

There is one US patent protecting LILLY drugs.

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

Summary for Lilly

International Patents:	30
US Patents:	1
Tradenames:	85
Ingredients:	81
NDAs:	105

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	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	PENICILLIN G POTASSIUM	penicillin g potassium	TABLET;ORAL	060403-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003	AB	RX	Yes	No
Lilly	QUINIDINE GLUCONATE	quinidine gluconate	INJECTABLE;INJECTION	007529-002	Feb 10, 1989		DISCN	Yes	No
Lilly	BETALIN 12	cyanocobalamin	INJECTABLE;INJECTION	080855-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	V-CILLIN K	penicillin v potassium	FOR SOLUTION;ORAL	060004-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lilly	NEBCIN	tobramycin sulfate	INJECTABLE;INJECTION	050519-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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	6,140,329
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	5,731,327
Lilly	CYMBALTA	duloxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021427-004	Aug 3, 2004	6,596,756*PED
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	7,550,434
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	8,030,330
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008	5,859,006*PED
Lilly	EVISTA	raloxifene hydrochloride	TABLET;ORAL	020815-001	Dec 9, 1997	RE38968

Paragraph IV (Patent) Challenges for LILLY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Lilly Drugs

Country	Patent Number	Estimated Expiration
Canada	2557897
Norway	20064955
South Africa	200606885
New Zealand	549099
Eurasian Patent Organization	200601801
Croatia	P20191242
China	1933864

Supplementary Protection Certificates for Lilly Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
1539166	92323	Luxembourg		PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624
1280520	300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	92678	Luxembourg		PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
0720599	CR 2014 00050	Denmark		PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
0933372	PA2008006,C0933372	Lithuania		PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712

Similar Applicant Names

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

• Lilly
• Lilly Res Labs