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-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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 090081-001 | Sep 7, 2010 | 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 | Y | ⤷ Sign Up | |||
| Mayne Pharma | NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154-001 | Apr 15, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Lupin Ltd | TYDEMY | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 205948-001 | Dec 12, 2017 | 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 |
|---|---|---|---|
| South Korea | 20190073598 | 드로스피레논을 포함하는 약학적 조성물 및 피임용 키트 (Pharmaceutical composition comprising drospirenone and contraceptive kit) | ⤷ Sign Up |
| Australia | 2011273605 | Pharmaceutical composition comprising drospirenone and contraceptive kit | ⤷ Sign Up |
| France | 20C1020 | ⤷ Sign Up | |
| South Africa | 201209743 | PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for drospirenone
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2588114 | LUC00227 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022 |
| 3632448 | 122022000040 | Germany | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DAENEMARK 61678 20191016 |
| 2588114 | 19/2020 | Austria | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
