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, 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-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.Drospirenone has sixty-five 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: | 65 |
| US Patents: | 21 |
| 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: | 3,354 |
| Formulation / Manufacturing: | see details |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DROSPIRENONE
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 201663-001 | Dec 18, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Exeltis Usa Inc | SLYND | drospirenone | TABLET;ORAL | 211367-001 | May 23, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Exeltis Usa Inc | SLYND | drospirenone | TABLET;ORAL | 211367-001 | May 23, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Watson Labs | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 078833-001 | Nov 28, 2011 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | NIKKI | drospirenone; ethinyl estradiol | TABLET;ORAL | 201661-001 | May 27, 2014 | AB | RX | No | 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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Lithuania | PA2021523 | ⤷ Sign Up | |
| France | 20C1020 | ⤷ Sign Up | |
| Eurasian Patent Organization | 201291372 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ДРОСПИРЕНОН, И НАБОР ДЛЯ ПРЕДУПРЕЖДЕНИЯ ЗАЧАТИЯ | ⤷ Sign Up |
| Hungary | E058176 | ⤷ Sign Up | |
| Norway | 2020015 | ⤷ Sign Up | |
| South Korea | 102210982 | ⤷ Sign Up | |
| Serbia | 63027 | FARMACEUTSKA KOMPOZICIJA KOJA OBUHVATA DROSPIRENON ZA UPOTREBU KAO KONTRACEPTIV (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE FOR USE AS A CONTRACEPTIVE) | ⤷ 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 | CA 2022 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
| 2588114 | CA 2020 00023 | Denmark | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON; NAT. REG. NO/DATE: 61678 20191016; FIRST REG. NO/DATE: DK 61678 20191016 |
| 3632448 | 22C1031 | France | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
| 0398460 | 04C0022 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 3632448 | 2022C/529 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107 |
| 2588114 | PA2021523 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: 61678 20191016 |
| 1214076 | C01214076/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
