HYLENEX RECOMBINANT Drug Profile
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Summary for Tradename: HYLENEX RECOMBINANT
| High Confidence Patents: | 4 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for HYLENEX RECOMBINANT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HYLENEX RECOMBINANT |
Recent Clinical Trials for HYLENEX RECOMBINANT
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 1 |
| The Wistar Institute | Phase 1 |
| Pablo Tebas | Phase 1 |
Recent Litigation for HYLENEX RECOMBINANT
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Halozyme, Inc. v. Lee | 2016-12-19 |
| Halozyme, Inc. v. Lee | 2016-12-18 |
Pharmacology for HYLENEX RECOMBINANT
| Established Pharmacologic Class | Endoglycosidase |
| Chemical Structure | Glycoside Hydrolases |
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 HYLENEX RECOMBINANT Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for HYLENEX RECOMBINANT Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2039-09-22 | Company disclosures |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2023-03-05 | Company disclosures |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2023-03-05 | Company disclosures |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2023-03-05 | Company disclosures |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for HYLENEX RECOMBINANT Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | Patent claims search | |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2017-05-29 | Patent claims search |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2028-03-05 | Patent claims search |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2039-02-26 | Patent claims search |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2032-10-16 | Patent claims search |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2031-10-25 | Patent claims search |
| Halozyme Therapeutics, Inc. | HYLENEX RECOMBINANT | hyaluronidase human | Injection | 021859 | ⤷ Sign Up | 2031-10-18 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for HYLENEX RECOMBINANT
Supplementary Protection Certificates for HYLENEX RECOMBINANT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 122015000061 | Germany | ⤷ Sign Up | PRODUCT NAME: TRASTUZUMAB UND RECOMBINANTE HUMANE HYALURONIDASE; REGISTRATION NO/DATE: EU/1/00/145/002 20130826 |
| C02405015/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: RITUXIMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65813 28.06.2016 |
| 2015C/044 | Belgium | ⤷ Sign Up | PRODUCT NAME: LA COMBINAISON DE TRASTUZUMAB ET HYALURONIDASE HUMAINE RECOMBINANTE; AUTHORISATION NUMBER AND DATE: EU/1/00/145/002 20130828 |
| PA2016022 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RITUKSIMABAS; REGISTRATION NO/DATE: EU/1/98/067/001-002 20140321 |
| C02163643/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TRASTUZUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65964 24.11.2016 |
| 132016000070123 | Italy | ⤷ Sign Up | PRODUCT NAME: RITUXIMAB IN ASSOCIAZIONE CON IALURONIDASI RICOMBINANTE UMANA - SOLUZIONE PER INIEZIONE SOTTOCUTANEA(MABTHERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/98/067/001-003, 20140326 |
| CR 2016 00031 | Denmark | ⤷ Sign Up | PRODUCT NAME: RITUXIMAB AND RECOMBINANT HUMAN HYALURONIDASE; NAT. REG. NO/DATE: EU/1/98/067/003-004 20140326; FIRST REG. NO/DATE: EU EU/1/98/067 20140326 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
