elestrin Drug Patent Profile
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Which patents cover Elestrin, and when can generic versions of Elestrin launch?
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-nine 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.
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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: | 4,159 |
| 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 |
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 |
|---|---|---|---|
| Canada | 2418135 | COMPOSITION POUR L'ADMINISTRATION TRANSDERMIQUE ET/OU TRANSMUQUEUSE DE COMPOSES ACTIFS ASSURANT DES NIVEAUX D'EFFICACITE THERAPEUTIQUE ADEQUATS (NOVEL COMPOSITION FOR TRANSDERMAL AND/OR TRANSMUCOSAL ADMINISTRATION OF ACTIVE COMPOUNDS THAT ENSURES ADEQUATE THERAPEUTIC LEVELS) | ⤷ Sign Up |
| Canada | 2515426 | UTILISATIONS ET FORMULES POUR L'APPLICATION TRANSDERMIQUE OU PAR VOIE TRANSMUQUEUSE D'AGENTS ACTIFS (USES AND FORMULATIONS FOR TRANSDERMAL OR TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS) | ⤷ Sign Up |
| European Patent Office | 1323431 | 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 |
| European Patent Office | 1670433 | FORMULATION PHARMACEUTIQUE TRANSDERMIQUE VISANT A REDUIRE LES RESIDUS SUR LA PEAU (TRANSDERMAL PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES) | ⤷ Sign Up |
| Japan | 2007524589 | ⤷ Sign Up | |
| Poland | 1670433 | ⤷ Sign Up | |
| South Africa | 200602046 | Transdermal pharmaceutical formulation for minimizing skin residues | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for elestrin
| 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 | 9/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| 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 |
| 2782584 | LUC00245 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701 |
| 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 |
| 2782584 | 21C1058 | France | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406 |
| 0285237 | 95C0008 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107 |
| >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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