LILETTA Drug Patent Profile

Which patents cover Liletta, and when can generic versions of Liletta launch?

Liletta is a drug marketed by Medicines360 and is included in one NDA. There are four 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-five 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:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	2
Patent Applications:	3,720
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

US Patents and Regulatory Information for LILETTA

LILETTA is protected by four 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	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes			Y
Medicines360	LILETTA	levonorgestrel	SYSTEM;INTRAUTERINE	206229-001	Feb 26, 2015		RX	Yes	Yes
Medicines360	LILETTA	levonorgestrel	SYSTEM;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
Brazil	112020019403	dispositivos de introdução de diu, e métodos relacionados e kits para os mesmos
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)
China	111902107	IUD插入装置和相关方法以及用于其的套件 (IUD insertion devices, and related methods and kits therefor)
Spain	2694173

Supplementary Protection Certificates for LILETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211