NEULASTA Drug Profile
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Summary for Tradename: NEULASTA
| High Confidence Patents: | 3 |
| Applicants: | 1 |
| BLAs: | 1 |
| Drug Prices: | Drug price information for NEULASTA |
| Recent Clinical Trials: | See clinical trials for NEULASTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NEULASTA |
Recent Clinical Trials for NEULASTA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Sutro Biopharma, Inc. | Phase 2 |
| Hospital Universitario Dr. Jose E. Gonzalez | Phase 2 |
| Camillo Ricordi and Jay Skyler | Phase 1/Phase 2 |
Pharmacology for NEULASTA
| Physiological Effect | Increased Myeloid Cell Production |
| Established Pharmacologic Class | Leukocyte Growth Factor |
| Chemical Structure | Granulocyte Colony-Stimulating Factor Granulocyte-Macrophage Colony-Stimulating Factor |
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 NEULASTA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for NEULASTA Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2013-12-03 | Company disclosures |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2013-12-10 | Company disclosures |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2039-02-26 | Company disclosures |
| Amgen, Inc. | NEULASTA ONPRO | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2013-12-03 | Company disclosures |
| Amgen, Inc. | NEULASTA ONPRO | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2013-12-10 | Company disclosures |
| Amgen, Inc. | NEULASTA ONPRO | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2039-02-26 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for NEULASTA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2033-03-11 | Patent claims search |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2021-05-01 | Patent claims search |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2036-04-01 | Patent claims search |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2039-02-26 | Patent claims search |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2036-06-13 | Patent claims search |
| Amgen, Inc. | NEULASTA | pegfilgrastim | Injection | 125031 | ⤷ Try a Trial | 2031-04-05 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for NEULASTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 86106234 | ⤷ Try a Trial |
| Japan | H0331437 | ⤷ Try a Trial |
| Australia | 1841995 | ⤷ Try a Trial |
| Japan | 5350330 | ⤷ Try a Trial |
| Saudi Arabia | 92130186 | ⤷ Try a Trial |
| China | 101381409 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NEULASTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 6/2003 | Austria | ⤷ Try a Trial | PRODUCT NAME: PEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/02/227/001 20020822 |
| 3/2014 | Austria | ⤷ Try a Trial | PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 MITTEILUNG VOM 28.07.2013 20130725 |
| CA 2014 00003 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LIPEGFILGRASTIM, HERUNDER METHOXYPOLYETHYLENGLYCOL KONJUGAT; REG. NO/DATE: EU/1/13/856 20130725 |
| 2014C/003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LIPEGFILGRASTIM; AUTHORISATION NUMBER AND DATE: EU/1/13/856 20130729 |
| C300637 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LIPEGFILGRASTIM; REGISTRATION NO/DATE: EU/1/13/856 20130725 |
| 92358 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LIPEGFILGRASTIM |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
