drospirenone Drug Patent Profile
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Which patents cover Drospirenone, and what generic alternatives are available?
Drospirenone is a drug marketed by Exeltis Usa Inc, Lupin Ltd, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc. and is included in twenty-one NDAs. There are fifteen patents protecting this drug.
This drug has sixty-six 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
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Questions you can ask:
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Summary for drospirenone
| International Patents: | 66 |
| US Patents: | 15 |
| Applicants: | 13 |
| NDAs: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 101 |
| Patent Applications: | 2,065 |
| 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 |
See drug prices for drospirenone
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
drospirenone is protected by fifteen 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
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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
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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
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Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Synthetic progestogens and pharmaceutical compositions comprising the same
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Synthetic progestogens and pharmaceutical compositions comprising the same
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Synthetic progestogens and pharmaceutical compositions comprising the same
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Synthetic progestogens and pharmaceutical compositions comprising the same
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Synthetic progestogens and pharmaceutical compositions comprising the same
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Synthetic progestogens and pharmaceutical compositions comprising the same
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Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Synthetic progestogens and pharmaceutical compositions comprising the same
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Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
FDA Regulatory Exclusivity protecting drospirenone
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Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Naari Pte Ltd | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 207245-001 | Nov 22, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 204848-001 | Mar 25, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xiromed | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 202131-001 | May 4, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hetero Labs | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 213034-001 | Jan 24, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Exeltis Usa Inc | DROSPIRENONE | drospirenone | TABLET, CHEWABLE;ORAL | 216285-001 | Jun 29, 2022 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
See the table below for patents covering drospirenone around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 2020015 | ⤷ Sign Up | |
| Mexico | 364971 | COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.) | ⤷ Sign Up |
| Hungary | E058176 | ⤷ Sign Up | |
| Hungary | S2000016 | ⤷ Sign Up | |
| Spain | 2908657 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for drospirenone
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3632448 | 22C1031 | France | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016 |
| 3632448 | 301186 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022 |
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 2588114 | C202030026 | Spain | ⤷ Sign Up | 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 |
| 2588114 | 301123 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RGV 127386 20210317; FIRST REGISTRATION: DK 31332 20191016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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