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 twenty branded drugs marketed by Exeltis Usa Inc, Mayne Pharma, Bayer Hlthcare, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-seven NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Drospirenone has sixty-nine patent family members in thirty-one countries.
There are eleven drug master file entries for drospirenone. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for drospirenone
International Patents: | 69 |
US Patents: | 23 |
Tradenames: | 20 |
Applicants: | 18 |
NDAs: | 37 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 101 |
Patent Applications: | 3,895 |
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 |
Generic filers with tentative approvals for DROSPIRENONE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | 4MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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
International Patents for drospirenone
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 3632448 | ⤷ Try for Free | |
San Marino | T202000063 | ⤷ Try for Free | |
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. | ⤷ Try for Free |
Portugal | 3632448 | ⤷ Try for Free | |
San Marino | T202200129 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for drospirenone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3632448 | CA 2022 00016 | Denmark | ⤷ Try for Free | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
3632448 | LUC00266 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
3632448 | C202230031 | Spain | ⤷ Try for Free | 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): SE/H/1809/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20191016 |
3632448 | 22C1031 | France | ⤷ Try for Free | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016 |
3632448 | 301186 | Netherlands | ⤷ Try for Free | PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Drospirenone
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