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Last Updated: February 29, 2020

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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 suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

US ANDA Litigation and Generic Entry Outlook for Balcoltra

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for BALCOLTRA
Recent Litigation for BALCOLTRA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Lannett Company Inc. v. KV Pharmaceuticals2008-06-06
Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company

See all BALCOLTRA litigation

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   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BALCOLTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521 CA 2016 00016 Denmark   Start Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
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