LILETTA Drug Patent Profile

When do Liletta patents expire, and what generic alternatives are available?

Liletta is a drug marketed by Medicines360 and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-three patent family members in nineteen countries.

The generic ingredient in LILETTA is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Liletta

A generic version of LILETTA was approved as levonorgestrel by NOVEL LABS INC on February 22^nd, 2013.

Summary for LILETTA

International Patents:	33
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2
Patent Applications:	4,459
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LILETTA
What excipients (inactive ingredients) are in LILETTA?	LILETTA excipients list
DailyMed Link:	LILETTA at DailyMed

See drug prices for LILETTA

Recent Clinical Trials for LILETTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kenya Medical Research Institute	Phase 4
Eastern Virginia Medical School	Phase 4
CONRAD	Phase 4

See all LILETTA clinical trials

Pharmacology for LILETTA

Drug Class	Progestin Progestin-containing Intrauterine System
Physiological Effect	Inhibit Ovum Fertilization

Anatomical Therapeutic Chemical (ATC) Classes for LILETTA

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for LILETTA

LILETTA is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting LILETTA

FDA Regulatory Exclusivity protecting LILETTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medicines360	LILETTA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y
Medicines360	LILETTA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes
Medicines360	LILETTA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes
Medicines360	LILETTA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y

International Patents for LILETTA

See the table below for patents covering LILETTA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013009674
Spain	2694173
Brazil	122015016218	dispositivo de inserção e kit
Georgia, Republic of	P20166482	) INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR
Canada	2841855	SYSTEMES INTRA-UTERINS, DISPOSITIFS D'INTRODUCTION DE DISPOSITIF INTRA-UTERIN (IUD), ET PROCEDES ASSOCIES ET TROUSSES POUR CEUX-CI (INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR)
South Korea	20140051296	INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR
Eurasian Patent Organization	201490251	ВНУТРИМАТОЧНЫЕ СИСТЕМЫ, УСТРОЙСТВА ВВЕДЕНИЯ УСТРОЙСТВ IUD (ВНУТРИМАТОЧНЫХ УСТРОЙСТВ) И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И НАБОРЫ

Supplementary Protection Certificates for LILETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129