CLIMARA PRO Drug Patent Profile
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Which patents cover Climara Pro, and what generic alternatives are available?
Climara Pro is a drug marketed by Bayer Hlthcare and is included in one NDA.
The generic ingredient in CLIMARA PRO is estradiol; levonorgestrel. 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; levonorgestrel profile page.
Summary for CLIMARA PRO
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 27 |
| Patent Applications: | 43 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CLIMARA PRO |
| What excipients (inactive ingredients) are in CLIMARA PRO? | CLIMARA PRO excipients list |
| DailyMed Link: | CLIMARA PRO at DailyMed |
Recent Clinical Trials for CLIMARA PRO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cystic Fibrosis Foundation | Phase 4 |
| Johns Hopkins University | Phase 4 |
| Sharon Nachman | Phase 2 |
Pharmacology for CLIMARA PRO
| Drug Class | Estrogen Progestin Progestin-containing Intrauterine System |
| Mechanism of Action | Estrogen Receptor Agonists |
| Physiological Effect | Inhibit Ovum Fertilization |
Anatomical Therapeutic Chemical (ATC) Classes for CLIMARA PRO
US Patents and Regulatory Information for CLIMARA PRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | CLIMARA PRO | estradiol; levonorgestrel | FILM, EXTENDED RELEASE;TRANSDERMAL | 021258-001 | Nov 21, 2003 | RX | Yes | Yes | ⤷ 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 CLIMARA PRO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | CLIMARA PRO | estradiol; levonorgestrel | FILM, EXTENDED RELEASE;TRANSDERMAL | 021258-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | CLIMARA PRO | estradiol; levonorgestrel | FILM, EXTENDED RELEASE;TRANSDERMAL | 021258-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | CLIMARA PRO | estradiol; levonorgestrel | FILM, EXTENDED RELEASE;TRANSDERMAL | 021258-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bayer Hlthcare | CLIMARA PRO | estradiol; levonorgestrel | FILM, EXTENDED RELEASE;TRANSDERMAL | 021258-001 | Nov 21, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLIMARA PRO
See the table below for patents covering CLIMARA PRO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2081352 | ⤷ Try a Trial | |
| Japan | H03204811 | ACTIVE PLASTER AND ITS PRODUCTION | ⤷ Try a Trial |
| Hungary | 9401257 | ⤷ Try a Trial | |
| Denmark | 0421454 | ⤷ Try a Trial | |
| Australia | 637637 | ⤷ Try a Trial | |
| Portugal | 101019 | SISTEMA TERAPEUTICO TRANSDERMICO CONTENDO INIBIDORES DE CRISTALIZACAO, NOMEADAMENTE, DIOXIDO DE SILICIO E COLESTEROL E SUA UTILIZACAO. | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLIMARA PRO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 15C0050 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| 0398460 | 12/2004 | Austria | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| 1453521 | C201630040 | Spain | ⤷ Try a Trial | 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 |
| 0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 1453521 | 39/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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