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Generated: February 18, 2019

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ETHINYL ESTRADIOL; NORGESTIMATE - Generic Drug Details

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What are the generic sources for ethinyl estradiol; norgestimate and what is the scope of ethinyl estradiol; norgestimate freedom to operate?

Ethinyl estradiol; norgestimate is the generic ingredient in eighteen branded drugs marketed by Janssen Pharms, Labs Leon Farma, Aurobindo Pharma Ltd, Novast Labs Ltd, Amneal Pharms, Glenmark Generics, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan Labs Ltd, Oc Pharma, Watson Labs, Vintage Pharms Llc, Barr, and Barr Labs Inc, 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.

Ethinyl estradiol; norgestimate has forty-six patent family members in twenty-six countries.

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

Summary for ETHINYL ESTRADIOL; NORGESTIMATE

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORGESTIMATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr Labs Inc TRI LO SPRINTEC ethinyl estradiol; norgestimate TABLET;ORAL-28 076784-001 Jun 29, 2009 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 201896-001 Jan 27, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO CYCLEN-28 ethinyl estradiol; norgestimate TABLET;ORAL-28 019653-002 Dec 29, 1989 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 076627-001 Aug 17, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd TRI-LO-MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205762-001 Nov 4, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ETHINYL ESTRADIOL; NORGESTIMATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for ETHINYL ESTRADIOL; NORGESTIMATE

Country Document Number Estimated Expiration
Russian Federation 2241709 ➤ Try a Free Trial
Hungary 0202249 ➤ Try a Free Trial
Czech Republic 20020065 ➤ Try a Free Trial
European Patent Office 1140109 ➤ Try a Free Trial
World Intellectual Property Organization (WIPO) 0038691 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORGESTIMATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/027 Belgium ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2016 00016 Denmark ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
C0001 France ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Fuji
Moodys
Deloitte
Daiichi Sankyo
Healthtrust
QuintilesIMS
AstraZeneca
Cerilliant

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