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PROMACTA Drug Profile
When do Promacta patents expire, and what generic alternatives are available?
Promacta is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are thirteen patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and eighty-nine patent family members in forty countries.
The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for PROMACTA
| International Patents: | 189 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 27 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PROMACTA |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for PROMACTA |
| DailyMed Link: | PROMACTA at DailyMed |
Pharmacology for PROMACTA
US Patents and Regulatory Information for PROMACTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-005 | Nov 16, 2012 | DISCN | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ 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 PROMACTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-002 | Nov 20, 2008 | ➤ Sign Up | ➤ Sign Up |
| Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-004 | Oct 20, 2011 | ➤ Sign Up | ➤ Sign Up |
| Novartis Pharms Corp | PROMACTA | eltrombopag olamine | TABLET;ORAL | 022291-001 | Nov 20, 2008 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for PROMACTA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 12.5 mg and 25 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Tablets | 50 mg and 75 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for PROMACTA
Supplementary Protection Certificates for PROMACTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1294378 | 388 | Finland | ➤ Sign Up | |
| 1294378 | SPC/GB10/026 | United Kingdom | ➤ Sign Up | PRODUCT NAME: ELTROMBOPAG, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE (INCLUDING A HYDRATE); REGISTERED: UK EU1/10/612/001 20100311; UK EU1/10/612/002 20100311; UK EU1/10/612/003 20100311; UK EU1/10/612/004 20100311; UK EU1/10/612/005 20100311; UK EU1/10/612/006 20100311 |
| 1534390 | PA2010007,C1534390 | Lithuania | ➤ Sign Up | PRODUCT NAME: ELTROMBOPAGUM OLAMINUM; REGISTRATION NO/DATE: EU/1/10/612/001, 2010-03-11 EU/1/10/612/002, 2010-03-11 EU/1/10/612/003, 2010-03-11 EU/1/10/612/004, 2010-03-11 EU/1/10/612/005, 2010-03-11 EU/1/10/612/006 20100311 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
