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-eight 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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Questions you can ask:
- What is the 5 year forecast for BALCOLTRA?
- What are the global sales for BALCOLTRA?
- What is Average Wholesale Price for BALCOLTRA?
Summary for BALCOLTRA
International Patents: | 3 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
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 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
United Kingdom | 2394474 | Enhancing solubility of iron amino acid chelates and iron proteinates | ⤷ Sign Up |
United Kingdom | 0403792 | ⤷ Sign Up | |
China | 1555228 | ⤷ Sign Up | |
Brazil | 0212399 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2005105112 | ⤷ 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 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |