ELTROMBOPAG OLAMINE Drug Patent Profile
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When do Eltrombopag Olamine patents expire, and what generic alternatives are available?
Eltrombopag Olamine is a drug marketed by Annora Pharma and is included in one NDA.
The generic ingredient in ELTROMBOPAG OLAMINE 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Eltrombopag Olamine
A generic version of ELTROMBOPAG OLAMINE was approved as eltrombopag olamine by ANNORA PHARMA on April 18th, 2024.
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Summary for ELTROMBOPAG OLAMINE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 16 |
| Patent Applications: | 249 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ELTROMBOPAG OLAMINE |
| DailyMed Link: | ELTROMBOPAG OLAMINE at DailyMed |
Recent Clinical Trials for ELTROMBOPAG OLAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Taiwan University Hospital | Phase 2 |
| Novartis | Phase 2 |
| Shaanxi Provincial People's Hospital | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for ELTROMBOPAG OLAMINE
Paragraph IV (Patent) Challenges for ELTROMBOPAG OLAMINE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PROMACTA KIT | For Oral Suspension | eltrombopag olamine | 12.5 mg/packet and 25 mg/packet | 207027 | 1 | 2022-04-22 |
| PROMACTA | Tablets | eltrombopag olamine | 12.5 mg and 25 mg | 022291 | 1 | 2014-02-04 |
| PROMACTA | Tablets | eltrombopag olamine | 50 mg and 75 mg | 022291 | 1 | 2014-01-07 |
US Patents and Regulatory Information for ELTROMBOPAG OLAMINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Annora Pharma | ELTROMBOPAG OLAMINE | eltrombopag olamine | FOR SUSPENSION;ORAL | 216620-001 | Apr 18, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | ELTROMBOPAG OLAMINE | eltrombopag olamine | FOR SUSPENSION;ORAL | 216620-002 | Apr 18, 2024 | AB | RX | No | 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 |
