MIRENA Drug Patent Profile

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

Mirena is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug.

This drug has forty-five patent family members in twenty countries.

The generic ingredient in MIRENA 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 Mirena

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

Summary for MIRENA

International Patents:	45
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	69
Patent Applications:	4,535
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MIRENA
What excipients (inactive ingredients) are in MIRENA?	MIRENA excipients list
DailyMed Link:	MIRENA at DailyMed

See drug prices for MIRENA

See drug sales revenues for MIRENA

Recent Clinical Trials for MIRENA

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

Sponsor	Phase
Arkansas Children's Hospital Research Institute	Phase 4
Boston Children's Hospital	Phase 2
Eastern Virginia Medical School	Phase 4

See all MIRENA clinical trials

Pharmacology for MIRENA

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

Anatomical Therapeutic Chemical (ATC) Classes for MIRENA

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 MIRENA

MIRENA is protected by two US patents.

Patents protecting MIRENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes			Y
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000		RX	Yes	Yes

Expired US Patents for MIRENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MIRENA	levonorgestrel	INTRAUTERINE DEVICE;INTRAUTERINE	021225-001	Dec 6, 2000

International Patents for MIRENA

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	101744
South Korea	100393708
Japan	5449366
South Korea	101604507
Mexico	2011002670	UN INSERTADOR. (AN INSERTER.)
South Korea	20110083598	AN INSERTER
Denmark	2349143

Supplementary Protection Certificates for MIRENA

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	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	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	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	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