Drospirenone - Generic Drug Details
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What are the generic sources for drospirenone and what is the scope of patent protection?
Drospirenone
is the generic ingredient in twenty branded drugs marketed by Exeltis Usa Inc, Lupin Ltd, Mayne Pharma, Bayer Hlthcare, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-eight NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Drospirenone has sixty-six patent family members in twenty-nine countries.
There are eleven drug master file entries for drospirenone. One supplier is listed for this compound.
Summary for drospirenone
| International Patents: | 66 |
| US Patents: | 22 |
| Tradenames: | 20 |
| Applicants: | 18 |
| NDAs: | 38 |
| Drug Master File Entries: | 11 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 101 |
| Patent Applications: | 3,525 |
| Drug Prices: | Drug price trends for drospirenone |
| Drug Sales Revenues: | Drug sales revenues for drospirenone |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for drospirenone |
| What excipients (inactive ingredients) are in drospirenone? | drospirenone excipients list |
| DailyMed Link: | drospirenone at DailyMed |
Recent Clinical Trials for drospirenone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| McGill University Health Centre/Research Institute of the McGill University Health Centre | Phase 4 |
| Eli Lilly and Company | Phase 1 |
| Bristol-Myers Squibb | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for drospirenone
Paragraph IV (Patent) Challenges for DROSPIRENONE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SLYND | Tablets | drospirenone | 4 mg | 211367 | 1 | 2022-01-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | KEMEYA | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 202138-001 | Mar 13, 2019 | DISCN | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Lupin Ltd | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 201663-001 | Dec 18, 2012 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Exeltis Usa Inc | DROSPIRENONE | drospirenone | TABLET, CHEWABLE;ORAL | 216285-001 | Jun 29, 2022 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Glenmark Pharms Ltd | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 204848-001 | Mar 25, 2016 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Exeltis Usa Inc | DROSPIRENONE | drospirenone | TABLET, CHEWABLE;ORAL | 216285-001 | Jun 29, 2022 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Exeltis Usa Inc | SLYND | drospirenone | TABLET;ORAL | 211367-001 | May 23, 2019 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Exeltis Usa Inc | DROSPIRENONE | drospirenone | TABLET, CHEWABLE;ORAL | 216285-001 | Jun 29, 2022 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| >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 | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 2020015 | ⤷ Subscribe | |
| Mexico | 2019004393 | COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.) | ⤷ Subscribe |
| Canada | 3061421 | METHOD OF PROVIDING CONTRACEPTION IN A PATIENT | ⤷ Subscribe |
| Lithuania | PA2021523 | ⤷ Subscribe | |
| Chile | 2012003685 | Kit farmaceutico que comprende una o mas unidades de envasado que comprenden 21 a 28 unidades de dosificacion activas diarias en que cada una comprende por lo menos 2 mg de drosperidona, sin estrogernos; uso del kit y de una composicion farmaceutica que comprende drosperidona para preparar un medicamento util como anticonceptivo. | ⤷ Subscribe |
| Serbia | 59826 | FARMACEUTSKA KOMPOZICIJA KOJA OBUHVATA DROSPIRENON I KONTRACEPTIVNI KOMPLET (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT) | ⤷ Subscribe |
| Ecuador | SP15032906 | COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO (DIVISIONAL 2 DE SOLICITUD No. SP-12-12359 PCT) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for drospirenone
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3632448 | PA2022513 | Lithuania | ⤷ Subscribe | PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419 |
| 3632448 | CA 2022 00016 | Denmark | ⤷ Subscribe | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
| 2588114 | LUC00227 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022 |
| 2588114 | C202030026 | Spain | ⤷ Subscribe | PRODUCT NAME: DROSPIRENONA; NATIONAL AUTHORISATION NUMBER: 84603-SE/H/1869/001/DC; DATE OF AUTHORISATION: 20191025; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 61678; DATE OF FIRST AUTHORISATION IN EEA: 20191016 |
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 3632448 | 122022000040 | Germany | ⤷ Subscribe | PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DAENEMARK 61678 20191016 |
| 3632448 | LUC00266 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
