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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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