CLIMARA Drug Patent Profile
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When do Climara patents expire, 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 | |||
| >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 |
| >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 | |
| Australia | 651234 | ⤷ Try a Trial | |
| Australia | 630347 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 0770388 | 09C0018 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
| 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 |
| >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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