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Last Updated: March 28, 2024

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balcoltra Drug Patent Profile


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Which patents cover Balcoltra, 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 and one Paragraph IV challenge.

This drug has three patent family members in three countries.

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

DrugPatentWatch® Generic Entry Outlook for Balcoltra

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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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Paragraph IV (Patent) Challenges for BALCOLTRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BALCOLTRA Tablets ethinyl estradiol; levonorgestrel 0.1 mg/0.02 mg 208612 1 2020-07-14

US Patents and Regulatory Information for balcoltra

balcoltra is protected by one US patents.

Patents protecting balcoltra

Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADMINISTRATION OF FERROUS BISGLYCINATE TABLETS

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 AB3 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for balcoltra

See the table below for patents covering balcoltra around the world.

Country Patent Number Title Estimated Expiration
China 1555228 ⤷  Try a Trial
Canada 2457584 AMELIORATION DE LA SOLUBILITE DES CHELATES D'ACIDES AMINES DE FER ET DES PROTEINATES DE FER (ENHANCING SOLUBILITY OF IRON AMINO ACID CHELATES AND IRON PROTEINATES) ⤷  Try a Trial
Brazil 0212399 ⤷  Try a Trial
China 1264428 ⤷  Try a Trial
Spain 2303739 AUMENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS CON HIERRO Y PROTEINATOS DE HIERRO. ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005105112 ⤷  Try a Trial
Germany 112005000909 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for balcoltra

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 CA 2006 00038 Denmark ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0398460 C300221 Netherlands ⤷  Try a Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 122015000093 Germany ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.