DROSPIRENONE AND ETHINYL ESTRADIOL Drug Patent Profile
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Which patents cover Drospirenone And Ethinyl Estradiol, and when can generic versions of Drospirenone And Ethinyl Estradiol launch?
Drospirenone And Ethinyl Estradiol is a drug marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Lupin Ltd, and Naari Pte Ltd. and is included in sixteen NDAs.
The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Drospirenone And Ethinyl Estradiol
A generic version of DROSPIRENONE AND ETHINYL ESTRADIOL was approved as drospirenone; ethinyl estradiol by DR REDDYS LABS SA on September 7th, 2010.
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Summary for DROSPIRENONE AND ETHINYL ESTRADIOL
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 10 |
| Clinical Trials: | 35 |
| DailyMed Link: | DROSPIRENONE AND ETHINYL ESTRADIOL at DailyMed |
Recent Clinical Trials for DROSPIRENONE AND ETHINYL ESTRADIOL
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 |
US Patents and Regulatory Information for DROSPIRENONE AND ETHINYL ESTRADIOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 078515-001 | Mar 30, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Xiromed | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 202594-001 | Oct 22, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hlthcare | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 203291-001 | Jul 18, 2017 | 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 | |||
| Apotex | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 205876-001 | Sep 21, 2016 | DISCN | 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 |
