DrugPatentWatch Database Preview
BALCOLTRA Drug Profile
When 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
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 |
|---|---|---|
| Mexico | PA04001475 | Start Trial |
| United Kingdom | 2394474 | Start Trial |
| United Kingdom | 0403792 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for BALCOLTRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1214076 | SZ 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| 1214076 | 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | 39/2015 | Austria | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
