ESTROGENS, CONJUGATED SYNTHETIC A - Generic Drug Details
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What are the generic drug sources for estrogens, conjugated synthetic a and what is the scope of freedom to operate?
Estrogens, conjugated synthetic a
is the generic ingredient in two branded drugs marketed by Teva Womens and Aspen, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for ESTROGENS, CONJUGATED SYNTHETIC A
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 6 |
| DailyMed Link: | ESTROGENS, CONJUGATED SYNTHETIC A at DailyMed |
Recent Clinical Trials for ESTROGENS, CONJUGATED SYNTHETIC A
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duramed Research | Phase 4 |
| Stanley Medical Research Institute | Phase 2 |
| The Alfred | Phase 2 |
Paragraph IV (Patent) Challenges for ESTROGENS, CONJUGATED SYNTHETIC A
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CENESTIN | Tablets | estrogens, conjugated synthetic a | 0.3 mg, 0.45 mg and 0.9 mg | 020992 | 1 | 2009-03-19 |
| CENESTIN | Tablets | estrogens, conjugated synthetic a | 0.625 mg | 020992 | 1 | 2009-03-02 |
| CENESTIN | Tablets | estrogens, conjugated synthetic a | 1.25 mg | 020992 | 1 | 2008-11-03 |
US Patents and Regulatory Information for ESTROGENS, CONJUGATED SYNTHETIC A
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-004 | Mar 13, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-001 | Jun 21, 2002 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-005 | Feb 5, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-002 | Mar 24, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Womens | SYNTHETIC CONJUGATED ESTROGENS A | estrogens, conjugated synthetic a | CREAM;VAGINAL | 021788-001 | Nov 28, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-003 | Mar 24, 1999 | DISCN | Yes | 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 ESTROGENS, CONJUGATED SYNTHETIC A
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-001 | Jun 21, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-003 | Mar 24, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-004 | Mar 13, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-002 | Mar 24, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Aspen | CENESTIN | estrogens, conjugated synthetic a | TABLET;ORAL | 020992-005 | Feb 5, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
