DROSPIRENONE Drug Patent Profile
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When do Drospirenone patents expire, and when can generic versions of Drospirenone launch?
Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Apotex, Dr Reddys Labs Sa, Lupin Ltd, Naari Pte Ltd, and Watson Labs Inc. and is included in twenty NDAs. There are thirteen patents protecting this drug.
This drug has sixty-five patent family members in twenty-nine countries.
The generic ingredient in DROSPIRENONE is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
DrugPatentWatch® Generic Entry Outlook for Drospirenone
Annual sales in 2021 were $29mm indicating the motivation for generic entry (peak sales were $59mm in 2019).
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for DROSPIRENONE
International Patents: | 65 |
US Patents: | 13 |
Applicants: | 13 |
NDAs: | 20 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 98 |
Patent Applications: | 2,065 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DROSPIRENONE |
Drug Sales Revenues: | Drug sales revenues for DROSPIRENONE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DROSPIRENONE |
DailyMed Link: | DROSPIRENONE at DailyMed |
Recent Clinical Trials for DROSPIRENONE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Colorado, Denver | Phase 2 |
Bristol Myers Squibb Company (BMS) | Phase 1 |
Janssen Pharmaceutica N.V., Belgium | 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
DROSPIRENONE is protected by thirteen US patents and one FDA Regulatory Exclusivity.
Patents protecting DROSPIRENONE
Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
FDA Regulatory Exclusivity protecting DROSPIRENONE
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
International Patents for DROSPIRENONE
See the table below for patents covering DROSPIRENONE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112012033391 | kit contraceptivo, método contraceptivo para uma paciente do sexo feminino necessitando do mesmo e composição farmacêutica compreendendo drospirenova. | ⤷ Try a Trial |
South Korea | 20130048227 | PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT | ⤷ Try a Trial |
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 a Trial |
South Korea | 102210982 | ⤷ Try a Trial | |
Guatemala | 201200336 | COMPOSICIÒN FARMACÈUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO | ⤷ Try a Trial |
Eurasian Patent Organization | 028680 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ДРОСПИРЕНОН, И НАБОР ДЛЯ ПРЕДУПРЕЖДЕНИЯ ЗАЧАТИЯ (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DROSPIRENONE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
2588114 | CA 2020 00023 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
3632448 | CA 2022 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
3632448 | 22C1031 | France | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
0398460 | 04C0022 | France | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
3632448 | 301186 | Netherlands | ⤷ Try a Trial | 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 |