NORDETTE-21 Drug Patent Profile
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Which patents cover Nordette-21, and what generic alternatives are available?
Nordette-21 is a drug marketed by Teva Branded Pharm and is included in one NDA.
The generic ingredient in NORDETTE-21 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
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Summary for NORDETTE-21
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 3 |
| Patent Applications: | 277 |
| DailyMed Link: | NORDETTE-21 at DailyMed |
Recent Clinical Trials for NORDETTE-21
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Desmond Tutu HIV Centre | N/A |
| União Química Farmacêutica Nacional S/A | Phase 3 |
| União Química Farmacêutica Nacional S.A. | Phase 3 |
US Patents and Regulatory Information for NORDETTE-21
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | 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 NORDETTE-21
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NORDETTE-21
See the table below for patents covering NORDETTE-21 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 1069847 | ⤷ Sign Up | |
| Austria | 268544 | ⤷ Sign Up | |
| Austria | 282083 | ⤷ Sign Up | |
| Germany | 1468643 | Verfahren zur Herstellung von 2-(1'-Tetralyliden-aethyl)-2-alkyl-cyclopentan-1,3-dionen | ⤷ Sign Up |
| Switzerland | 421096 | Verfahren zur Herstellung von Steroiden | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NORDETTE-21
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 39/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1214076 | 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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