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Generated: April 26, 2019

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BALCOLTRA Drug Profile

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When do Balcoltra patents expire, and what generic alternatives are available?

Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has eleven patent family members in nine countries.

The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Drug patent expirations by year for BALCOLTRA
Synonyms for BALCOLTRA
Ethinyl estradiol mixture with levonorgestrel and ferrous bisglycinate
Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets
S900007780

US Patents and Regulatory Information for BALCOLTRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avion Pharms BALCOLTRA ethinyl estradiol; levonorgestrel TABLET;ORAL 208612-001 Jan 9, 2018 RX No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
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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Supplementary Protection Certificates for BALCOLTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium ➤ Sign Up PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 122015000093 Germany ➤ Sign Up PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1380301 CA 2009 00017 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521 39/2015 Austria ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217 CA 2006 00038 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 15C0050 France ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1214076 49/2008 Austria ➤ Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Medtronic
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