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Last Updated: May 21, 2022

BALCOLTRA Drug Patent Profile


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Which patents cover Balcoltra, and when can generic versions of Balcoltra launch?

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-two 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.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
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) See Plans and Pricing
Australia 2002331603 See Plans and Pricing
Mexico PA04001475 MEJORAMIENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS DE HIERRO Y DE PROTEINATOS DE HIERRO. (ENHANCING SOLUBILITY OF IRON AMINO ACID CHELATES AND IRON PROTEINATES.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BALCOLTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 C01214076/01 Switzerland See Plans and Pricing PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301 2009C/007 Belgium See Plans and Pricing PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0136011 2000C/027 Belgium See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
>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.