ORTHO TRI-CYCLEN Drug Patent Profile
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When do Ortho Tri-cyclen patents expire, and what generic alternatives are available?
Ortho Tri-cyclen is a drug marketed by Janssen Pharms and is included in two NDAs.
The generic ingredient in ORTHO TRI-CYCLEN is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
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Summary for ORTHO TRI-CYCLEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 20 |
| Patent Applications: | 8 |
| Drug Prices: | Drug price information for ORTHO TRI-CYCLEN |
| DailyMed Link: | ORTHO TRI-CYCLEN at DailyMed |
Recent Clinical Trials for ORTHO TRI-CYCLEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gilead Sciences | Phase 1 |
| Lexicon Pharmaceuticals | Phase 1 |
| Aegerion Pharmaceuticals, Inc. | Phase 1 |
US Patents and Regulatory Information for ORTHO TRI-CYCLEN
| 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 TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-21 | 019697-002 | Jul 3, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 019697-001 | Jul 3, 1992 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharms | ORTHO TRI-CYCLEN LO | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 021241-001 | Aug 22, 2002 | 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 TRI-CYCLEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-21 | 019697-002 | Jul 3, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-21 | 019697-002 | Jul 3, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 019697-001 | Jul 3, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 019697-001 | Jul 3, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharms | ORTHO TRI-CYCLEN | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 019697-001 | Jul 3, 1992 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ORTHO TRI-CYCLEN
See the table below for patents covering ORTHO TRI-CYCLEN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 450108 | ⤷ Sign Up | |
| Netherlands | 192206 | ⤷ Sign Up | |
| Croatia | P940806 | ⤷ Sign Up | |
| Philippines | 12003 | 3-OXIMES OF D-17ALPHA-ETHYNYL-19-NORTESTOSTERONE ESTERS AND METHOD | ⤷ Sign Up |
| Yugoslavia | 173376 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORTHO TRI-CYCLEN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 1453521 | 39/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: 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 | 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 |
| >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.
ISSN: 2162-2639
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