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-nine 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VAGIFEM?
- What are the global sales for VAGIFEM?
- What is Average Wholesale Price for VAGIFEM?
Summary for VAGIFEM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 14 |
Patent Applications: | 4,098 |
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 |
---|---|
University of Washington | Phase 2 |
Breast Cancer Research Foundation | Phase 2 |
Koru Health Groups | N/A |
Pharmacology for VAGIFEM
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-001 | Mar 26, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Novo Nordisk Inc | VAGIFEM | estradiol | TABLET;VAGINAL | 020908-002 | Nov 25, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Germany | 20120246 | ⤷ Sign Up | |
Denmark | 2366395 | ⤷ Sign Up | |
Japan | 2004515531 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 9801180 | ⤷ Sign Up | |
Portugal | 1343508 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VAGIFEM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0770388 | PA2009004,C0770388 | Lithuania | ⤷ Sign Up | 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 | 9/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
1453521 | C 2015 029 | Romania | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
2782584 | LUC00245 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701 |
1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |