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Generated: November 19, 2018

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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.

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

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
Watson Labs NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 076626-001 Aug 17, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 205588-001 Apr 26, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205449-001 Jul 7, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Oc Pharma NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200383-001 Apr 7, 2015 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 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORGESTIMATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2009 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
00221 Netherlands ➤ Try a Free Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2006 00038 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Colorcon
Julphar
Dow
Farmers Insurance
Moodys
Teva
McKesson
Cipla

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