CLIMARA Drug Patent Profile
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Which patents cover Climara, and when can generic versions of Climara launch?
Climara is a drug marketed by Bayer Hlthcare and is included in two NDAs.
The generic ingredient in CLIMARA 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
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 27 |
Patent Applications: | 4,321 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CLIMARA |
Drug Sales Revenues: | Drug sales revenues for CLIMARA |
What excipients (inactive ingredients) are in CLIMARA? | CLIMARA excipients list |
DailyMed Link: | CLIMARA at DailyMed |
Recent Clinical Trials for CLIMARA
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
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for CLIMARA
US Patents and Regulatory Information for CLIMARA
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 | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-004 | Mar 5, 1999 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
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 | ||||
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-006 | May 27, 2003 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-005 | May 27, 2003 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-001 | Dec 22, 1994 | AB2 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-002 | Dec 22, 1994 | AB2 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-003 | Mar 23, 1998 | AB2 | RX | 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 CLIMARA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-001 | Dec 22, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-006 | May 27, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-004 | Mar 5, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-002 | Dec 22, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-003 | Mar 23, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | CLIMARA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020375-005 | May 27, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLIMARA
See the table below for patents covering CLIMARA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | H03502925 | ⤷ Try a Trial | |
Germany | 68917292 | ⤷ Try a Trial | |
Luxembourg | 88849 | ⤷ Try a Trial | |
Australia | 2097892 | ⤷ Try a Trial | |
Australia | 630347 | ⤷ Try a Trial | |
Netherlands | 970007 | ⤷ Try a Trial | |
Hong Kong | 1006545 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CLIMARA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
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 |
0770388 | PA2009004 | Lithuania | ⤷ Try a Trial | 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 |
0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
0770388 | PA2009004,C0770388 | Lithuania | ⤷ Try a Trial | 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 |
0771217 | 07C0001 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
0136011 | 2000C/027 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |