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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ortho Evra
A generic version of ORTHO EVRA was approved as ethinyl estradiol; norelgestromin by AMNEAL on February 25th, 2021.
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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 |
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 |
International Patents for ORTHO EVRA
See the table below for patents covering ORTHO EVRA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 3534775 | ⤷ Sign Up | |
China | 1190351 | ⤷ Sign Up | |
Norway | 316308 | ⤷ Sign Up | |
Hungary | 9802326 | ⤷ Sign Up | |
Australia | 703593 | ⤷ Sign Up | |
Norway | 975586 | ⤷ Sign Up | |
Czech Republic | 9703932 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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 |