You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 18, 2024

~ Buy the BALCOLTRA (ethinyl estradiol; levonorgestrel) Drug Profile, 2024 PDF Report in the Report Store ~

BALCOLTRA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-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

< Available with Subscription >

  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up 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

International Patents for BALCOLTRA

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

Country Patent Number Title Estimated Expiration
South Africa 200401218 Enhancing solubility of iron amino acid chelates and iron proteinates. ⤷  Sign Up
Germany 112005000909 ⤷  Sign Up
United Kingdom 2394474 Enhancing solubility of iron amino acid chelates and iron proteinates ⤷  Sign Up
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.) ⤷  Sign Up
Spain 2303739 AUMENTO DE LA SOLUBILIDAD DE QUELATOS DE AMINOACIDOS CON HIERRO Y PROTEINATOS DE HIERRO. ⤷  Sign Up
Australia 2002331603 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BALCOLTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1380301 2009C/007 Belgium ⤷  Sign Up PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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 300814 Netherlands ⤷  Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076 SZ 49/2008 Austria ⤷  Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0771217 07C0001 France ⤷  Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.