.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Ethinyl estradiol; norgestimate - Generic Drug Details

« Back to Dashboard
Ethinyl estradiol; norgestimate is the generic ingredient in eighteen branded drugs marketed by Barr, Novast Labs Ltd, Watson Labs, Lupin Ltd, Jai Pharma Ltd, Sandoz Inc, Vintage Pharms Llc, Glenmark Generics, Lupin Pharms, Janssen Pharms, Aurobindo Pharma Ltd, Glenmark Pharms, Amneal Pharms, Haupt Pharma, Oc Pharma, Barr Labs Inc, and Sandoz, and is included in thirty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in twenty-five countries.

There are twenty-six drug master file entries for ethinyl estradiol; norgestimate. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norgestimate

Tradenames:18
Patents:1
Applicants:17
NDAs:33
Drug Master File Entries: see list26
Suppliers / Packagers: see list21
Clinical Trials: see list260
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28204057-001Feb 23, 2016RXNo► subscribe► subscribe
Lupin Ltd
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28205588-001Apr 26, 2016RXNo► subscribe► subscribe
Glenmark Generics
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28200538-001Apr 5, 2012RXNo► subscribe► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 19924,628,051► subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 20024,530,839*PED► subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 19924,027,019► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: ethinyl estradiol; norgestimate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,809,107 Neurotrophic pyrrolidines and piperidines, and related compositions and methods► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: ethinyl estradiol; norgestimate

Country Document Number Estimated Expiration
Germany69930157► subscribe
Hungary0202249► subscribe
Canada2379149► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ETHINYL ESTRADIOL; NORGESTIMATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/027Belgium► subscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2016 00016Denmark► subscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
2009 00017Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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 verifification 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.

`abc