vagifem Drug Patent Profile
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When do Vagifem patents expire, and what generic alternatives are available?
Vagifem is a drug marketed by Novo Nordisk Inc and is included in one NDA.
The generic ingredient in VAGIFEM 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 Vagifem
A generic version of vagifem was approved as estradiol by BARR LABS INC on October 22nd, 1997.
Summary for vagifem
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 12 |
Patent Applications: | 6,715 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for vagifem |
Drug Sales Revenues: | Drug sales revenues for vagifem |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for vagifem |
What excipients (inactive ingredients) are in vagifem? | vagifem excipients list |
DailyMed Link: | vagifem at DailyMed |
Recent Clinical Trials for vagifem
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Angelica Lindén Hirschberg | Phase 4 |
University Hospitals Cleveland Medical Center | Phase 4 |
Kaiser Permanente | Phase 3 |
Pharmacology for vagifem
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for vagifem
US Patents and Regulatory Information for vagifem
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-001 | Mar 26, 1999 | DISCN | Yes | No | ⤷ 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 vagifem
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for vagifem
See the table below for patents covering vagifem around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4851057 | ⤷ Try a Trial | |
Austria | 240764 | ⤷ Try a Trial | |
Spain | 2376649 | ⤷ Try a Trial | |
Denmark | 1343508 | ⤷ Try a Trial | |
European Patent Office | 0910427 | INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 9801180 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 0247692 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for vagifem
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 |