NPLATE Drug Profile
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Summary for Tradename: NPLATE
| High Confidence Patents: | 4 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for NPLATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NPLATE |
Recent Clinical Trials for NPLATE
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Geropharm | Phase 1 |
| Amgen | Early Phase 1 |
| Anjali Sharathkumar | Early Phase 1 |
Recent Litigation for NPLATE
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Vanda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-04-30 |
Pharmacology for NPLATE
| Mechanism of Action | Thrombopoietin Receptor Agonists |
| Physiological Effect | Increased Megakaryocyte Maturation Increased Platelet Production |
| Established Pharmacologic Class | Thrombopoietin Receptor Agonist |
Note on Biologic Patents
Matching patents to biologic drugs is far more complicated than for small-molecule drugs.
DrugPatentWatch employs three methods to identify biologic patents:
- Brand-side disclosures in response to biosimilar applications
- General brand-side disclosures
- Patents from broad patent text search
These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.
These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.
1) High Certainty: US Patents for NPLATE Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for NPLATE Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2018-10-23 | Company disclosures |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2018-10-23 | Company disclosures |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2018-10-23 | Company disclosures |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2018-10-23 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for NPLATE Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2033-03-11 | Patent claims search |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2034-11-21 | Patent claims search |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2039-02-26 | Patent claims search |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2031-04-20 | Patent claims search |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2031-04-05 | Patent claims search |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2035-10-02 | Patent claims search |
| Amgen Inc. | NPLATE | romiplostim | For Injection | 125268 | ⤷ Sign Up | 2039-12-21 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for NPLATE
Supplementary Protection Certificates for NPLATE
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| SPC/GB09/035 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ROMIPLOSTIM; REGISTERED: UK EU/1/08/497/001 20090206; UK EU/1/08/497/002 20090206 |
| PA2009006,C1124961 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ROMIPLOSTIMUM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090204 |
| C01124961/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTATIVE: BOHEST AG, CH |
| SZ 25/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: ROMIPLOSTIM |
| C200900026 | Spain | ⤷ Sign Up | PRODUCT NAME: ROMIPLOSTIM; NATIONAL AUTHORISATION NUMBER: 1/08/497/001-002; DATE OF AUTHORISATION: 20090204; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/08/497/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20090204 |
| 09C0030 | France | ⤷ Sign Up | PRODUCT NAME: ROMIPLOSTIM; REGISTRATION NO/DATE: EU/1/08/497/001-002 20090206 |
| 91598 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ROMIPLOSTIM (NPLATE - ROMIPLOSTIM); AUTHORISATION NUMBER AND DATE: EU/1/08/497/001-002 20090206 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
