VAGIFEM Drug Patent Profile
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When do Vagifem patents expire, and when can generic versions of Vagifem launch?
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 |
| Fred Hutchinson Cancer Research Center | 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 |
|---|---|---|---|
| Austria | 240764 | ⤷ Try a Trial | |
| Cyprus | 1112542 | ⤷ Try a Trial | |
| European Patent Office | 2366395 | ⤷ Try a Trial | |
| Germany | 20120246 | ⤷ Try a Trial | |
| Denmark | 1343508 | ⤷ Try a Trial | |
| Japan | 4851057 | ⤷ Try a Trial | |
| European Patent Office | 1343508 | UTILISATION D'UN OESTROGENE DANS LA FABRICATION D'UNE COMPOSITION CONTENANT DE L'OESTROGENE POUR LE TRAITEMENT DE LA VAGINITE ATROPHIQUE (USE OF AN OESTROGEN IN THE MANUFACTURE OF A COMPOSITION CONTAINING OESTROGEN FOR THE TREATMENT OF ATROPHIC VAGINITIS) | ⤷ 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 |
|---|---|---|---|---|
| 1214076 | 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 2782584 | 21C1058 | France | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406 |
| 0136011 | C00136011/03 | Switzerland | ⤷ Try a Trial | PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417 |
| 1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
| 0771217 | CA 2006 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103 |
| 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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