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MIRENA Drug Profile

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Which patents cover Mirena, 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-four patent family members in twenty countries.

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

Summary for MIRENA

International Patents:	44
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	74
Clinical Trials:	53
Patent Applications:	3,411
Formulation / Manufacturing:	see details
DailyMed Link:	MIRENA at DailyMed

Pharmacology for MIRENA

Ingredient-type	Progesterone Congeners
Drug Class	Progestin Progestin-containing Intrauterine Device
Physiological Effect	Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for MIRENA

Contraceptive Agents, Female

Contraceptives, Oral, Synthetic

Synonyms for MIRENA

(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one

(-)-17alpha-Ethynyl-18-methyl-19-nortestosterone

(-)-18,19-Dinor-13beta-ethyl-17beta-hydroxy-4-pregnen-20-yn-3-one

(-)-Levonorgestrel

(-)-Norgestrel

(-)-Norgestrel, 98%

(+-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one

(+-)-Norgestrel

(17?)-13-Ethyl-17-hydroxy-18,19-dinorpregn-4-en-yn-3-one

(1S,2R,10R,11S,14R,15S)-15-ethyl-14-ethynyl-14-hydroxytetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one

(1S,2R,10R,11S,14R,15S)-15-ETHYL-14-ETHYNYL-14-HYDROXYTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE

(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy- 1,2,6,7,8,9,10,11,12,13,14,15,16, 17- tetradecahydrocyclopenta[a] phenanthren-3-one

(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one

(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one

(8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-oxidanyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one

[(-)-13-ethyl-17-hydroxy-18,19-dinor-17a-pregn-4-en-20-yn-3-one

[18,(17.alpha.)-(-)-]

121714-72-5

13-BETA-ETHYL-17-ALPHA-ETHYNYL-17-BETA-HYDROXYGON-4-EN-3-ONE

13-beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one

13-Ehyl-17alpha-ethynyl-17-hydroxygon-4-en-3-one

13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one

13-Ethyl-17-alpha-ethynylgon-4-en-17-beta-ol-3-one

13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one

13-Ethyl-17alpha-ethynyl-17-hydroxygon-4-en-3-one

13-ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one

13-Ethyl-17alpha-ethynylgon-4-en-17beta-ol-3-one

13-ethyl-17alpha-hydroxy-18,19-dinorpregn-4-en-20-yn-3-one

13beta-Ethyl-17alpha-ethynyl-17 beta-hydroxygon-4-en-3-one

13beta-ethyl-17alpha-ethynyl-17-hydroxy-gon-4-en-3-one

13beta-ethyl-17alpha-ethynyl-17beta-hydroxy-gon-4-en-3-one

13beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one

17-alpha-Ethinyl-13-beta-ethyl-17-beta-hydroxy-4-estren-3-one

17-alpha-Ethynyl-13-ethyl-19-nortestosterone

17-beta-Hydroxy-18-methyl-19-nor-17-alpha-pregn-4-en-20-yn-3-one

17-Ethynyl-18-methyl-19-nortestosterone

17alpha-Ethynyl-13-ethyl-19-nortestosterone

17alpha-Ethynyl-13beta-ethyl-3-oxo-4-estren-17beta-ol

17alpha-Ethynyl-17-hydroxy-18-methylestr-4-en-3-one

17alpha-ethynyl-17beta-hydroxy-18a-homoestr-4-en-3-one

17alpha-Ethynyl-18-homo-19-nor-testosterone

17alpha-Ethynyl-18-homo-19-nortestosterone

18-Methyl-17-alpha-ethynyl-19-nortestosterone

18-Methylnorethindrone

18-Methylnorethisterone

18,19-Dinor-13beta-ethyl-17 beta hydroxy-4-pregnen-20-yn-3-one

18,19-Dinor-13beta-ethyl-17beta-hydroxy-4-pregnen-20-yn-3-one

18,19-Dinor-17-alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-

18,19-Dinor-17-alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (+-)-

18,19-Dinor-17-alpha-pregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (+)-

18,19-Dinor-4-pregnen-20-yn-3-one

18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(-)-

18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(+-)-

19-Nortestosterone, 17-ethynyl-18-methyl-

1lhv

4222-79-1

5W7SIA7YZW

6533-00-2

72-HOURS

797-62-6

797-63-7

797L637

A835065

AB0012485

AB2000252

AC1L211U

AC1Q6OEV

AJ-45701

AK161683

AKOS015894913

alpha-Norgestrel

BAY 86-5028

BAY86-5028

BCP9000852

BDBM50410522

BIDD:PXR0194

Bio-0595

BPBio1_000932

BRD-K35189033-001-03-0

BRN 2391114

BSPBio_000846

C08149

C08153

Capronor

CAS-797-63-7

CCG-100853

CCRIS 6525

CCRIS 9033

CHEBI:6443

CHEMBL1389

component of Lo/ovral

CS-2243

D-(-)-Norgestrel

D-Norgestrel

d(-)-Norgestrel

D(-)-Norgestrel, analytical standard

D00950

D00954

D0A9MR

D0BA9U

D0G6CT

DB00367

dl-13-beta-Ethyl-17-alpha-ethynyl-17-beta-hydroxygon-4-en-3-one

dl-13-beta-Ethyl-17-alpha-ethynyl-19-nortestosterone

dl-Norgestrel

DNorgestrel

DSSTox_CID_16496

DSSTox_GSID_36496

DSSTox_RID_79283

DTXSID3036496

E-Gen-C

EINECS 212-349-8

EINECS 229-433-5

EN300-122613

Fallback Solo

FH 122-A

Follistrel

FT-0658692

GTPL2881

HMS1570K08

HMS2051M08

HMS2090O06

HMS2097K08

HMS2232H06

HMS2232K12

HMS3649J10

HSDB 3595

HSDB 6483

HY-B0257

Jadelle

Kyleena

Ld norgestrel

LD norgestrel [French]

Levlen

Levlen ED

Levogel

Levonelle

Levonelle, D-Norgestrel, Levonova, Levonorgestrel

Levonelle;D-Norgestrel;Levonova

Levonorgestrel

Levonorgestrel (JAN/USP/INN)

Levonorgestrel (Levonelle)

Levonorgestrel [USAN:INN:BAN]

Levonorgestrel [USAN:USP:INN:BAN]

Levonorgestrel for system suitability 2, European Pharmacopoeia (EP) Reference Standard

Levonorgestrel implants

Levonorgestrel, European Pharmacopoeia (EP) Reference Standard

Levonorgestrel, pharmaceutical secondary standard; traceable to USP, PhEur, BP

Levonorgestrel, United States Pharmacopeia (USP) Reference Standard

Levonorgestrel(Levonelle)

Levonorgestrelum

Levonorgestrelum [INN-Latin]

Levonova

Levora-21

Levora-28

Levosert

Liletta

LMST02030119

LNG-IUS

LO/Ovral

Logynon ED

LS-62083

LS-62084

MCULE-1283162506

Methylnorethindrone

MFCD00199013

Microgest ED

Microgyn

Microgynon 21

Microgynon 28

Microgynon 30 ED

Microgynon CD

Microlut

Microlution

Microluton

Microval

Minivlar 30

Mirena (TN)

MLS000069491

MLS000759484

MLS001074069

MLS001423967

MolPort-002-510-453

Monofeme 28

Monovar

N0889

NC00103

NCGC00159349-02

NCGC00159349-03

NCGC00159349-05

NCGC00257283-01

NCGC00260418-01

Neogest

Neogynon 21

Next choice

Nordet

Nordette

Nordette 21

Nordette 28

Norgeston

norgestrel

Norgestrel (JP15/USP/INN)

Norgestrel (JP17/USP/INN)

Norgestrel [Progestins]

Norgestrel [USAN:BAN:INN:JAN]

Norgestrel [USAN:INN:BAN:JAN]

Norgestrel [USAN:USP:INN:BAN:JAN]

Norgestrel-(-)-D

Norgestrelum

Norgestrelum [INN-Latin]

NorLevo

NORPLANT

Norplant (TN)

Norplant 2

Norplant II

Norplant System in Plastic Container

Norplant-2

NSC-744007

NSC744007

Opera_ID_552

Ovoplex 30-150

Ovral

Ovral-Lo

Ovranette

Ovrette

Ovrette (TN)

PL000229

Plan B

Plan B One Step

Plan B One-Step

Postinor

Postinor-2

Prestwick_109

Prestwick0_000773

Prestwick1_000773

Prestwick2_000773

Prestwick3_000773

Preven

Rigevidon 21+7

s1727

SCHEMBL27597

SH 70850

SH 850

Skyla

Skyla (TN)

SMR000059117

SMR000653526

SOH-075

SPBio_002785

SR-01000759218

SR-01000759218-5

SR-01000946725

SR-01000946725-1

Stediril 30

Tetragynon

Tox21_111593

Tox21_111593_1

Tox21_202872

Tox21_303658

Tri-Levlen

Tri-Levlen 21

Triagynon

Triciclor

Trifeme 28

Trigoa

Trinordiol 21

Trinordiol 28

Triphasil 21

Triphasil 28

Triquilar ED

Trivora

UNII-3J8Q1747Z2 component WWYNJERNGUHSAO-XUDSTZEESA-N

UNII-5W7SIA7YZW

WWYNJERNGUHSAO-XUDSTZEESA-N

Wy 3707

Wy-3707

Wy-5104

Z1551429747

ZINC3814395

US Patents and Regulatory Information for 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			Y

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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

Non-Orange Book US Patents for MIRENA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,452,082	Inserter
D810289	Inserter
D791318	Inserter

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International Patents for MIRENA

Country	Document Number	Estimated Expiration
Japan	5390618
Israel	211059
Mexico	2011002671
South Africa	201100896

Supplementary Protection Certificates for MIRENA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211