PREFEST Drug Patent Profile
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Which patents cover Prefest, and when can generic versions of Prefest launch?
Prefest is a drug marketed by Teva Womens and is included in one NDA.
The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norgestimate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prefest
A generic version of PREFEST was approved as estradiol; norgestimate by BARR on April 29th, 2005.
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Summary for PREFEST
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | PREFEST at DailyMed |
US Patents and Regulatory Information for PREFEST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 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 PREFEST
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Womens | PREFEST | estradiol; norgestimate | TABLET;ORAL | 021040-001 | Oct 22, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PREFEST
See the table below for patents covering PREFEST around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Turkey | 200102860 | ⤷ Sign Up | |
| Austria | 209919 | ⤷ Sign Up | |
| Finland | 972370 | ⤷ Sign Up | |
| Finland | 884378 | ⤷ Sign Up | |
| Argentina | 029159 | PREPARACION FARMACEUTICA, ENVASE QUE LA CONTIENE Y USO EN LA PREPARACION DE UN MEDICAMENTO UTIL EN LA TERAPIA DE REEMPLAZO HORMONAL | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9414450 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0059577 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PREFEST
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0334429 | 97C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 1453521 | 15C0050 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| 1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 0398460 | 12/2004 | Austria | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| 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 |
| 0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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