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Generated: June 26, 2019

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Ethinyl estradiol; levonorgestrel - Generic Drug Details

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty branded drugs marketed by Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Labs Leon Farma, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Novast Labs, Sun Pharm, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, and Vintage Pharms Llc, and is included in sixty-eight NDAs. There are eight patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has one hundred and three patent family members in twenty-six countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ethinyl estradiol; levonorgestrel
Pharmacology for ethinyl estradiol; levonorgestrel
Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vintage Pharms Llc MYZILRA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 077502-001 Nov 23, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cadence Health ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-21 020683-001 Mar 27, 1997 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd AFIRMELLE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 206886-001 Nov 14, 2016 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novast Labs SETLAKIN ethinyl estradiol; levonorgestrel TABLET;ORAL 090716-001 Sep 15, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma LEVORA 0.15/30-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 073594-001 Dec 13, 1993 AB RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cadence Health ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 020683-002 Mar 27, 1997 DISCN Yes 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; levonorgestrel

International Patents for ethinyl estradiol; levonorgestrel

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C20160011 00192 Estonia ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
1214076 C01214076/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0136011 2000C/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
1453521 300814 Netherlands ➤ Try a Free Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
1453521 2015C/042 Belgium ➤ Try a Free Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
0771217 CA 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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