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-four 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
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: ⤷ 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 | 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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) | ⤷ Try a Trial |
| Brazil | 0212399 | ⤷ Try a Trial | |
| 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.) | ⤷ Try a Trial |
| European Patent Office | 1737470 | CHELATES D'ACIDES AMINES METALLIQUES HYPOALLERGENIQUES ET COMPOSITIONS A BASE DE CHELATES D'ACIDES AMINES METALLIQUES (HYPOALLERGENIC METAL AMINO ACID CHELATES AND METAL AMINO ACID CHELATE-CONTAINING COMPOSITIONS) | ⤷ Try a Trial |
| China | 1264428 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 1214076 | SZ 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| 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 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| >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.
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