vagifem Drug Patent Profile
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Which patents cover Vagifem, 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-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.
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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: | 4,119 |
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 |
University of Minnesota | 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 |
---|---|---|---|
Germany | 20120246 | ⤷ Sign Up | |
Denmark | 1343508 | ⤷ Sign Up | |
Japan | 2010189409 | USE OF OESTROGEN IN MANUFACTURE OF COMPOSITION CONTAINING OESTROGEN FOR TREATMENT OF ATROPHIC VAGINITIS | ⤷ Sign Up |
Australia | 2156702 | ⤷ 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 | SPC/GB09/026 | United Kingdom | ⤷ Sign Up | 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 |
1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
0584952 | 99C0004 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |