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-seven 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: | 12 |
Patent Applications: | 4,103 |
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 |
![VAGIFEM drug patent expirations Drug patent expirations by year for VAGIFEM](/p/graph/s/t/VAGIFEM-patent-expirations.png)
![Drug Prices for VAGIFEM](/p/graph/drug-price/VAGIFEM.png)
![Drug Sales Revenue Trends for VAGIFEM](/p/graph/drug-sales-revenues/VAGIFEM.png)
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 |
University of Washington | Phase 3 |
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 |
---|---|---|---|
Australia | 3254397 | ⤷ Sign Up | |
Australia | 2156702 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
European Patent Office | 0910427 | INSTRUMENT POUR L'INTRODUCTION D'UN SUPPOSITOIRE (INSTRUMENT FOR INSERTING A SUPPOSITORY) | ⤷ Sign Up |
Germany | 69722203 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VAGIFEM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0136011 | 2000C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
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 |
1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
1380301 | CA 2009 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |