Dienogest; estradiol valerate - Generic Drug Details
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What are the generic drug sources for dienogest; estradiol valerate and what is the scope of freedom to operate?
Dienogest; estradiol valerate
is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Dienogest; estradiol valerate has ninety patent family members in thirty-nine countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for dienogest; estradiol valerate
| International Patents: | 90 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 14 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dienogest; estradiol valerate |
| DailyMed Link: | dienogest; estradiol valerate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dienogest; estradiol valerate
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for dienogest; estradiol valerate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Andromaco S.A. | Phase 1 |
| Suleymaniye Birth And Women's Health Education And Research Hospital | Phase 4 |
| Kocaeli Derince Education and Research Hospital | Phase 4 |
Generic filers with tentative approvals for DIENOGEST; ESTRADIOL VALERATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Anatomical Therapeutic Chemical (ATC) Classes for dienogest; estradiol valerate
Paragraph IV (Patent) Challenges for DIENOGEST; ESTRADIOL VALERATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NATAZIA | Tablets | dienogest; estradiol valerate | 3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg | 022252 | 1 | 2010-10-22 |
US Patents and Regulatory Information for dienogest; estradiol valerate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | NATAZIA | dienogest; estradiol valerate | TABLET;ORAL | 022252-001 | May 6, 2010 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bayer Hlthcare | NATAZIA | dienogest; estradiol valerate | TABLET;ORAL | 022252-001 | May 6, 2010 | 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 dienogest; estradiol valerate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | NATAZIA | dienogest; estradiol valerate | TABLET;ORAL | 022252-001 | May 6, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | NATAZIA | dienogest; estradiol valerate | TABLET;ORAL | 022252-001 | May 6, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dienogest; estradiol valerate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 200829255 | Use of oestradiol in combination with dienogest for the oral treatment of dysfunctional uterine bleeding in conjunction with oral contraception | ⤷ Sign Up |
| Germany | 502006008853 | ⤷ Sign Up | |
| Japan | 4908399 | ⤷ Sign Up | |
| South Africa | 200609594 | MULTI-PHASE CONTRACEPTIVE PREPARATION BASED ON A ESTROGEN | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dienogest; estradiol valerate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0770388 | SPC/GB09/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
| 0770388 | 2009/012 | Ireland | ⤷ Sign Up | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
| 0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
| 0770388 | 9/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
