Lybrel Drug Patent Profile
✉ Email this page to a colleague
When do Lybrel patents expire, and when can generic versions of Lybrel launch?
Lybrel is a drug marketed by Wyeth Pharms Inc and is included in one NDA.
The generic ingredient in LYBREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for Lybrel
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 2 |
Patent Applications: | 339 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Lybrel |
DailyMed Link: | Lybrel at DailyMed |
Recent Clinical Trials for Lybrel
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Pfizer | |
Boston Collaborative Drug Surveillance Program | |
Oregon Health and Science University | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for Lybrel
Paragraph IV (Patent) Challenges for LYBREL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LYBREL | Tablets | ethinyl estradiol; levonorgestrel | 0.09 mg/0.02 mg | 021864 | 1 | 2007-10-05 |
US Patents and Regulatory Information for Lybrel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Wyeth Pharms Inc | LYBREL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021864-001 | May 22, 2007 | 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 Lybrel
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Wyeth Pharms Inc | LYBREL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021864-001 | May 22, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Lybrel
See the table below for patents covering Lybrel around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1935423 | ⤷ Try a Trial | |
Germany | 59808545 | ⤷ Try a Trial | |
Denmark | 1011682 | ⤷ Try a Trial | |
European Patent Office | 1011682 | MOYEN DE CONTRACEPTION HORMONALE (HORMONAL CONTRACEPTIVE) | ⤷ Try a Trial |
Australia | 1140999 | ⤷ Try a Trial | |
Portugal | 1011682 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Lybrel
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 |
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 |
1380301 | CA 2009 00017 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
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 |
1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |