ELESTRIN Drug Patent Profile
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When do Elestrin patents expire, and what generic alternatives are available?
Elestrin is a drug marketed by Mylan Speciality Lp and is included in one NDA.
The generic ingredient in ELESTRIN 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 Elestrin
A generic version of ELESTRIN was approved as estradiol by BARR LABS INC on October 22nd, 1997.
Summary for ELESTRIN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 1 |
Patent Applications: | 4,193 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ELESTRIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELESTRIN |
What excipients (inactive ingredients) are in ELESTRIN? | ELESTRIN excipients list |
DailyMed Link: | ELESTRIN at DailyMed |
Recent Clinical Trials for ELESTRIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Missouri-Columbia | N/A |
Pharmacology for ELESTRIN
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ELESTRIN
US Patents and Regulatory Information for ELESTRIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | RX | Yes | Yes | ⤷ 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 ELESTRIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | ELESTRIN | estradiol | GEL, METERED;TRANSDERMAL | 021813-001 | Dec 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ELESTRIN
See the table below for patents covering ELESTRIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2007508261 | ⤷ Sign Up | |
China | 1997357 | ⤷ Sign Up | |
Spain | 2283665 | ⤷ Sign Up | |
European Patent Office | 1323430 | Composition pour l' administration percutanée et/ou par voie transmucosale de principes actifs assurant des niveaux d'efficacité thérapeutiques adéquats (Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels) | ⤷ Sign Up |
Austria | 485837 | ⤷ Sign Up | |
China | 105853396 | ⤷ Sign Up | |
Japan | 2007524589 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ELESTRIN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2861072 | 2024C/512 | Belgium | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406 |
0771217 | 07C0001 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
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 |
0584952 | 99C0004 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
1453521 | C201630040 | Spain | ⤷ Sign Up | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |