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BALCOLTRA Drug Profile
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See Plans and PricingWhen do Balcoltra patents expire, and what generic alternatives are available?
Balcoltra is a drug marketed by Avion Pharms and is included in one NDA. There is one patent protecting this drug.
This drug has eleven patent family members in nine countries.
The generic ingredient in BALCOLTRA is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
US ANDA Litigation and Generic Entry Outlook for Balcoltra
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
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: | 11 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BALCOLTRA |
| DailyMed Link: | BALCOLTRA at DailyMed |
Recent Litigation for BALCOLTRA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Lannett Company Inc. v. KV Pharmaceuticals | 2008-06-06 |
| Breckenridge Pharmaceutical, Inc. v. KV Pharmaceutical Company |
Synonyms for BALCOLTRA
| Ethinyl estradiol mixture with levonorgestrel and ferrous bisglycinate |
| Levonorgestrel and ethinyl estradiol tablets and ferrous bisglycinate tablets |
| S900007780 |
US Patents and Regulatory Information for BALCOLTRA
| 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 | No | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 200401218 | Start Trial |
| United Kingdom | 0403792 | Start Trial |
| China | 1555228 | Start Trial |
| Canada | 2457584 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BALCOLTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 93156 | Luxembourg | Start Trial | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 0771217 | CA 2006 00038 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 1214076 | C01214076/01 | Switzerland | Start Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
| 1453521 | CA 2016 00016 | Denmark | Start Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
