LILETTA Drug Patent Profile

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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.

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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:	3,674
Drug Prices:	Drug price information for LILETTA
What excipients (inactive ingredients) are in LILETTA?	LILETTA excipients list
DailyMed Link:	LILETTA at DailyMed

Drug patent expirations by year for LILETTA

Recent Clinical Trials for LILETTA

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

Sponsor	Phase
Eastern Virginia Medical School	Phase 4
CONRAD	Phase 4
United States Agency for International Development (USAID)	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

Intrauterine systems, IUD insertion devices, and related methods and kits therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR PREVENTION OF PREGNANCY

Methods for using intrauterine systems and IUD insertion devices
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR PREVENTION OF PREGNANCY

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting LILETTA

TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR UP TO 5 YEARS IN PATIENTS WHO CHOOSE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

International Patents for LILETTA

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

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Country	Patent Number	Title	Estimated Expiration
South Africa	201500334	INTRAUTERINE SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR	⤷ Sign Up
European Patent Office	3773370	SYSTÈMES D'INSERTION DE DISPOSITIFS INTRA-UTÉRINS (DIU), PROCÉDÉS ET KITS ASSOCIÉS (IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR)	⤷ Sign Up
Georgia, Republic of	P20166482	) INTRAURINARY SYSTEMS, IUD INSERTION DEVICES, AND RELATED METHODS AND KITS THEREFOR	⤷ Sign Up
Chile	2014000080	Dispositivo de insercion que comprende una vaina alargada, un miembro interno alargado, una interfaz de usuario, y un deslizador de vaina movil en comunicacion con la vaina alargada; kit; metodo de uso.	⤷ Sign Up
China	104023681	Intraurinary systems, IUD insertion devices, and related methods and kits therefor	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LILETTA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C201630040	Spain	⤷ Sign Up	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	122015000093	Germany	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	39/2015	Austria	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	300814	Netherlands	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	C 2015 029	Romania	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description