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 |
---|---|---|---|
Canada | 2120599 | SYSTEMES THERAPEUTIQUES TRANSDERMIQUES CONTENANT DES INHIBITEURS DE CRISTALLISATION (TRANSDERMAL THERAPEUTIC SYSTEMS CONTAINING CRYSTALLIZATION INHIBITORS) | ⤷ Try a Trial |
Denmark | 0421454 | ⤷ Try a Trial | |
European Patent Office | 0416842 | Système de matrice solide pour l'administration transcutanée de médicaments. (Solid matrix system for transdermal drug delivery.) | ⤷ Try a Trial |
Ireland | 72141 | Dressing containing estrogen | ⤷ Try a Trial |
Spain | 2081352 | ⤷ 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 | 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 |
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 | 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 |
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 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |