Drospirenone; ethinyl estradiol; levomefolate calcium - Generic Drug Details
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What are the generic sources for drospirenone; ethinyl estradiol; levomefolate calcium and what is the scope of freedom to operate?
Drospirenone; ethinyl estradiol; levomefolate calcium
is the generic ingredient in four branded drugs marketed by Bayer Hlthcare, Lupin Ltd, and Watson Labs Inc, and is included in six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Three suppliers are listed for this compound.
Summary for drospirenone; ethinyl estradiol; levomefolate calcium
| US Patents: | 2 |
| Tradenames: | 4 |
| Applicants: | 3 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for drospirenone; ethinyl estradiol; levomefolate calcium |
| DailyMed Link: | drospirenone; ethinyl estradiol; levomefolate calcium at DailyMed |
Recent Clinical Trials for drospirenone; ethinyl estradiol; levomefolate calcium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 3 |
See all drospirenone; ethinyl estradiol; levomefolate calcium clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; ethinyl estradiol; levomefolate calcium
Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BEYAZ | Tablets | drospirenone; ethinyl estradiol; levomefolate calcium | 3 mg/0.02 mg/ 0.451 mg and 0.451 mg | 022532 | 1 | 2012-11-13 |
| SAFYRAL | Tablets | drospirenone; ethinyl estradiol; levomefolate calcium | 3 mg/0.03 mg/ 0.451 mg and 0.451 mg | 022574 | 1 | 2012-09-28 |
US Patents and Regulatory Information for drospirenone; ethinyl estradiol; levomefolate calcium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Watson Labs Inc | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 203593-001 | Oct 11, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs Inc | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 203594-001 | Oct 11, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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; levomefolate calcium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | BEYAZ | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022532-001 | Sep 24, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
