DROSPIRENONE; ETHINYL ESTRADIOL - Generic Drug Details
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What are the generic drug sources for drospirenone; ethinyl estradiol and what is the scope of freedom to operate?
Drospirenone; ethinyl estradiol
is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Sixteen suppliers are listed for this compound.
Summary for DROSPIRENONE; ETHINYL ESTRADIOL
| US Patents: | 2 |
| Tradenames: | 16 |
| Applicants: | 16 |
| NDAs: | 33 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 9 |
| Clinical Trials: | 35 |
| Patent Applications: | 1,428 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DROSPIRENONE; ETHINYL ESTRADIOL |
| DailyMed Link: | DROSPIRENONE; ETHINYL ESTRADIOL at DailyMed |
Recent Clinical Trials for DROSPIRENONE; 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 |
Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ETHINYL ESTRADIOL
Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| YAZ | Tablets | drospirenone; ethinyl estradiol | 3 mg/0.02 mg | 021676 | 1 | 2006-09-29 |
| YASMIN | Tablets | drospirenone; ethinyl estradiol | 3 mg/0.03 mg | 021098 | 1 | 2005-01-07 |
US Patents and Regulatory Information for DROSPIRENONE; ETHINYL ESTRADIOL
| 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, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 205947-001 | Jun 13, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | KEMEYA | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 202138-001 | Mar 13, 2019 | DISCN | No | No | ⤷ 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 | |||
| Barr | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 077527-001 | May 9, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | |||
| Barr | DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL | 078515-001 | Mar 30, 2009 | 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 |
Expired US Patents for DROSPIRENONE; ETHINYL ESTRADIOL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
