Drospirenone; ethinyl estradiol - Generic Drug Details
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What are the generic 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, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, 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.Fifteen suppliers are listed for this compound.
Summary for drospirenone; ethinyl estradiol
US Patents: | 2 |
Tradenames: | 16 |
Applicants: | 17 |
NDAs: | 33 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 9 |
Clinical Trials: | 32 |
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 |
---|---|
Women's Hospital School Of Medicine Zhejiang University | Phase 4 |
University of California, San Francisco | Phase 4 |
American University of Beirut Medical Center | Phase 2/Phase 3 |
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
Expired US Patents for drospirenone; ethinyl estradiol
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | YAZ | drospirenone; ethinyl estradiol | TABLET;ORAL | 021676-001 | Mar 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | YASMIN | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 021098-001 | May 11, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |