MENOSTAR Drug Patent Profile
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Which patents cover Menostar, and what generic alternatives are available?
Menostar is a drug marketed by Bayer Hlthcare and is included in one NDA.
The generic ingredient in MENOSTAR is estradiol. There are seventy-five drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the estradiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Menostar
A generic version of MENOSTAR was approved as estradiol by BARR LABS INC on October 22nd, 1997.
Summary for MENOSTAR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 2 |
Patent Applications: | 5,456 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MENOSTAR |
What excipients (inactive ingredients) are in MENOSTAR? | MENOSTAR excipients list |
DailyMed Link: | MENOSTAR at DailyMed |
Recent Clinical Trials for MENOSTAR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bayer | Phase 3 |
Pharmacology for MENOSTAR
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for MENOSTAR
US Patents and Regulatory Information for MENOSTAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | MENOSTAR | estradiol | SYSTEM;TRANSDERMAL | 021674-001 | Jun 8, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 MENOSTAR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | MENOSTAR | estradiol | SYSTEM;TRANSDERMAL | 021674-001 | Jun 8, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | MENOSTAR | estradiol | SYSTEM;TRANSDERMAL | 021674-001 | Jun 8, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | MENOSTAR | estradiol | SYSTEM;TRANSDERMAL | 021674-001 | Jun 8, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MENOSTAR
See the table below for patents covering MENOSTAR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 136175 | Kit containing estrogen for postmenopausal use | ⤷ Try a Trial |
China | 100398110 | ⤷ Try a Trial | |
Poland | 193897 | ⤷ Try a Trial | |
Eurasian Patent Organization | 004573 | СПОСОБЫ ЛЕЧЕНИЯ ЖЕНЩИН В ПОСТКЛИМАКТЕРИЧЕСКОМ СОСТОЯНИИ С ПРИМЕНЕНИЕМ УЛЬТРАНИЗКИХ ДОЗ ЭСТРОГЕНА (METHOD FOR TREATING POSTMENOPAUSAL WOMEN USING ULTRA-LOW DOSES OF ESTROGEN) | ⤷ Try a Trial |
Poland | 341112 | ⤷ Try a Trial | |
Austria | 109357 | ⤷ Try a Trial | |
Brazil | 9814984 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MENOSTAR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0334429 | 97C0002 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
2782584 | C202130068 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
2782584 | 301153 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406 |
0136011 | C00136011/03 | Switzerland | ⤷ Try a Trial | PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417 |
0771217 | 07C0001 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
0770388 | SPC/GB09/026 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |