DROSPIRENONE - Generic Drug Details
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What are the generic drug sources for drospirenone and what is the scope of freedom to operate?
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. There is one tentative approval 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 |
Generic filers with tentative approvals for DROSPIRENONE
Applicant | Application No. | Strength | Dosage Form |
⤷ Subscribe | ⤷ Subscribe | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Exeltis Usa Inc | DROSPIRENONE | drospirenone | TABLET, CHEWABLE;ORAL | 216285-001 | Jun 29, 2022 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ 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 |
---|---|---|---|
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 | 63027 | FARMACEUTSKA KOMPOZICIJA KOJA OBUHVATA DROSPIRENON ZA UPOTREBU KAO KONTRACEPTIV (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE FOR USE AS A CONTRACEPTIVE) | ⤷ Subscribe |
Peru | 20161410 | COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO | ⤷ Subscribe |
>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 | ⤷ Subscribe | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
3632448 | 301186 | Netherlands | ⤷ Subscribe | PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022 |
1380301 | 2009C/007 | Belgium | ⤷ Subscribe | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DROSPIRENONE Market Analysis and Financial Projection Experimental
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