➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Dow
Medtronic
Colorcon
Harvard Business School

Last Updated: July 4, 2020

DrugPatentWatch Database Preview

ORTHO-NOVUM 7/7/7-21 Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which 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.

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

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Dow
Medtronic
Colorcon
Harvard Business School

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.