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Last Updated: September 19, 2020

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NORDETTE-21 Drug 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. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NORDETTE-21
Drug patent expirations by year for NORDETTE-21
Recent Clinical Trials for NORDETTE-21

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Desmond Tutu HIV CentreN/A
Azidus BrasilPhase 3
União Química Farmacêutica Nacional S.A.Phase 3

See all NORDETTE-21 clinical trials

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   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982   Start Trial   Start Trial
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NORDETTE-21

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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