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
Summary for BALCOLTRA
International Patents: | 3 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BALCOLTRA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BALCOLTRA |
What excipients (inactive ingredients) are in BALCOLTRA? | BALCOLTRA excipients list |
DailyMed Link: | BALCOLTRA at DailyMed |


Anatomical Therapeutic Chemical (ATC) Classes for BALCOLTRA
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 |
Expired US Patents for BALCOLTRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |