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ORTHO-NOVUM 7/7/7-21 Drug Profile
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» See Plans and PricingWhich patents cover Ortho-novum 7/7/7-21, and when can generic versions of Ortho-novum 7/7/7-21 launch?
Ortho-novum 7/7/7-21 is a drug marketed by Janssen Pharms and is included in one NDA.
The generic ingredient in ORTHO-NOVUM 7/7/7-21 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for ORTHO-NOVUM 7/7/7-21
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 3 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ORTHO-NOVUM 7/7/7-21 at DailyMed |
Paragraph IV (Patent) Challenges for ORTHO-NOVUM 7/7/7-21
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ORTHO-NOVUM 7/7/7-21 | TABLET;ORAL-21 | ethinyl estradiol; norethindrone | 018985 | |
| ORTHO-NOVUM 7/7/7-28 | TABLET;ORAL-28 | ethinyl estradiol; norethindrone | 018985 |
US Patents and Regulatory Information for ORTHO-NOVUM 7/7/7-21
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Pharms | ORTHO-NOVUM 7/7/7-21 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018985-001 | Apr 4, 1984 | 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 ORTHO-NOVUM 7/7/7-21
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | ORTHO-NOVUM 7/7/7-21 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018985-001 | Apr 4, 1984 | Start Trial | Start Trial |
| Janssen Pharms | ORTHO-NOVUM 7/7/7-21 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018985-001 | Apr 4, 1984 | Start Trial | Start Trial |
| Janssen Pharms | ORTHO-NOVUM 7/7/7-21 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018985-001 | Apr 4, 1984 | Start Trial | Start Trial |
| Janssen Pharms | ORTHO-NOVUM 7/7/7-21 | ethinyl estradiol; norethindrone | TABLET;ORAL-21 | 018985-001 | Apr 4, 1984 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ORTHO-NOVUM 7/7/7-21
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 1226221 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ORTHO-NOVUM 7/7/7-21
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | C300221 | Netherlands | Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 1214076 | SZ 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| 1453521 | 39/2015 | Austria | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 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 |
| 0771217 | 07C0001 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| 0771217 | CA 2006 00038 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
