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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-five patent family members in twenty countries.
The generic ingredient in MIRENA is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
US ANDA Litigation and Generic Entry Outlook for Mirena
A generic version of MIRENA was approved as levonorgestrel by L PERRIGO CO on December 30th, 2010.
Summary for MIRENA
| International Patents: | 45 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 58 |
| Patent Applications: | 3,547 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MIRENA |
| Drug Sales Revenues: | Drug sales revenues for MIRENA |
| DailyMed Link: | MIRENA at DailyMed |
Recent Clinical Trials for MIRENA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai First Maternity and Infant Hospital | Early Phase 1 |
| Kocaeli University | N/A |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Phase 4 |
Pharmacology for MIRENA
| Drug Class | Progestin Progestin-containing Intrauterine Device |
| Physiological Effect | Inhibit Ovum Fertilization |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Bayer Hlthcare | MIRENA | levonorgestrel | INTRAUTERINE DEVICE;INTRAUTERINE | 021225-001 | Dec 6, 2000 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MIRENA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 201100896 | Start Trial |
| Denmark | 2349143 | Start Trial |
| Taiwan | I472320 | Start Trial |
| Russian Federation | 2011115057 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MIRENA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 15C0050 | France | Start Trial | 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 | CA 2016 00016 | Denmark | Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| 1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 132016000025143 | Italy | Start Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
