NORDETTE-21 Drug Patent Profile
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 is one drug master file entry for this compound. Twenty-two 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: | 692 |
| 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 |
| Azidus Brasil | 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 | ⤷ 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 | 3,666,858 | ⤷ Start Trial |
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | 3,959,322 | ⤷ Start Trial |
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | 3,850,911 | ⤷ Start Trial |
| >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 |
|---|---|---|---|
| Belgium | 716736 | ⤷ Start Trial | |
| Cyprus | 658 | Pharmaceutical compositions | ⤷ Start Trial |
| Denmark | 130949 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NORDETTE-21
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0136011 | 2000C/027 | Belgium | ⤷ Start Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
| 0398460 | C300221 | Netherlands | ⤷ Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1214076 | C01214076/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |

