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Last Updated: November 7, 2024

ORTHO EVRA Drug Patent Profile


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Which patents cover Ortho Evra, and when can generic versions of Ortho Evra launch?

Ortho Evra is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ORTHO EVRA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

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Summary for ORTHO EVRA
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 48
Patent Applications: 130
DailyMed Link:ORTHO EVRA at DailyMed
Drug patent expirations by year for ORTHO EVRA
Drug Sales Revenue Trends for ORTHO EVRA

See drug sales revenues for ORTHO EVRA

Paragraph IV (Patent) Challenges for ORTHO EVRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ORTHO EVRA Transdermal System ethinyl estradiol; norelgestromin 0.15 mg/0.02 mg per 24 hours 021180 1 2007-03-22

US Patents and Regulatory Information for ORTHO EVRA

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 EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 DISCN Yes 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 ORTHO EVRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms ORTHO EVRA ethinyl estradiol; norelgestromin FILM, EXTENDED RELEASE;TRANSDERMAL 021180-001 Nov 20, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ORTHO EVRA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gedeon Richter Plc. Evra norelgestromin, ethinyl estradiol EMEA/H/C/000410
Female contraception.Evra is intended for women of fertile age. The safety and efficacy has been established in women aged 18 to 45 years.
Authorised no no no 2002-08-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for ORTHO EVRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076 C01214076/01 Switzerland ⤷  Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
1214076 49/2008 Austria ⤷  Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 122015000093 Germany ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 93156 Luxembourg ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0771217 07C0001 France ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>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.