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Last Updated: February 26, 2020

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Ethinyl estradiol; norgestrel - Generic Drug Details

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What are the generic drug sources for ethinyl estradiol; norgestrel and what is the scope of patent protection?

Ethinyl estradiol; norgestrel is the generic ingredient in eleven branded drugs marketed by Duramed Pharms Barr, Cadence Health, Mayne Pharma, Watson Labs, Wyeth Pharms, Novast Labs Ltd, and Mylan Labs Ltd, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norgestrel. Four suppliers are listed for this compound.

Recent Clinical Trials for ethinyl estradiol; norgestrel

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SponsorPhase
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 1
National Cancer Institute (NCI)Phase 2

See all ethinyl estradiol; norgestrel clinical trials

Recent Litigation for ethinyl estradiol; norgestrel

Identify potential future generic entrants

District Court Litigation
Case NameDate
Boston Scientific Corporation v. Conor Medsystems Inc.2005-11-08

See all ethinyl estradiol; norgestrel litigation

US Patents and Regulatory Information for ethinyl estradiol; norgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs OGESTREL 0.5/50-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075406-001 Dec 15, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs OGESTREL 0.5/50-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 075406-002 Dec 15, 1999 RX No Yes   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; norgestrel TABLET;ORAL-28 202875-001 May 8, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; norgestrel TABLET;ORAL-28 201828-001 Jun 21, 2016 DISCN No No   Start Trial   Start Trial   Start 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 ethinyl estradiol; norgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms LO/OVRAL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 017802-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Cadence Health LO/OVRAL ethinyl estradiol; norgestrel TABLET;ORAL-21 017612-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms OVRAL ethinyl estradiol; norgestrel TABLET;ORAL-21 016672-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Wyeth Pharms OVRAL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 016806-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Moodys
Mallinckrodt
Express Scripts
Medtronic

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