Ortho Evra Drug Patent Profile
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When do Ortho Evra patents expire, and what generic alternatives are available?
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.
Summary for Ortho Evra
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Patent Applications: | 153 |
Formulation / Manufacturing: | see details |
DailyMed Link: | Ortho Evra at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Janssen Pharms | ORTHO EVRA | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 021180-001 | Nov 20, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Czech Republic | 292151 | Transdermální náplast pro podávání 17-deacetylnorgestimátu samotného nebo v kombinaci s estrogenem (Transdermal patch and method for administering 17-deacetyl norgestimate alone or in combination with estrogen) | ⤷ Try a Trial |
Poland | 181582 | ⤷ Try a Trial | |
Austria | 229828 | ⤷ Try a Trial | |
Hungary | 228434 | TRANSDERMAL MEDICAMENT FOR ADMINISTERING 17-DEACETYL NORGESTIMATE ALONE OR IN COMBINATION WITH AN ESTROGEN | ⤷ Try a Trial |
European Patent Office | 0836506 | TIMBRE TRANSDERMIQUE POUR L'ADMINISTRATION DE 17-DEACETYL NORGESTIMATE EN COMBINAISON AVEC UN ESTROGENE (TRANSDERMAL PATCH FOR ADMINISTERING 17-DEACETYL NORGESTIMATE IN COMBINATION WITH AN ESTROGEN) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Ortho Evra
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0771217 | 07C0001 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
0136011 | 2000C/027 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1380301 | 2009C/007 | Belgium | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
0771217 | CA 2006 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
1453521 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |