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Drospirenone - Generic Drug Details
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What are the generic drug sources for drospirenone and what is the scope of patent protection?
Drospirenone
is the generic ingredient in eighteen branded drugs marketed by Exeltis Usa Inc, Bayer Hlthcare, Allied, Barr, Glenmark Pharms Ltd, Hetero Labs Ltd, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, Novast Labs, Lupin Ltd, Apotex, Mayne Pharma, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-five NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Drospirenone has forty-five patent family members in twenty-seven countries.
There are eleven drug master file entries for drospirenone. One supplier is listed for this compound.
Summary for drospirenone
| International Patents: | 45 |
| US Patents: | 9 |
| Tradenames: | 18 |
| Applicants: | 18 |
| NDAs: | 35 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 89 |
| Patent Applications: | 2,550 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for drospirenone |
| Drug Sales Revenues: | Drug sales revenues for drospirenone |
| DailyMed Link: | drospirenone at DailyMed |
Recent Clinical Trials for drospirenone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 4 |
| Quotient Sciences | Phase 1 |
| Janssen Sciences Ireland UC | Phase 1 |
Pharmacology for drospirenone
| Drug Class | Progestin |
US Patents and Regulatory Information for drospirenone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Watson Labs Inc | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 203593-001 | Oct 11, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hetero Labs Ltd | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 211944-001 | Mar 22, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for drospirenone
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 102164693 | Start Trial |
| Mexico | 339952 | Start Trial |
| Serbia | 59826 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for drospirenone
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1214076 | C01214076/01 | Switzerland | Start Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 2588114 | 19/2020 | Austria | Start Trial | PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022 |
| 0398460 | 04C0022 | France | Start Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| >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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