AMPHADASE Drug Profile
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Summary for Tradename: AMPHADASE
Recent Clinical Trials for AMPHADASE
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Amphastar Pharmaceuticals, Inc. | Phase 2 |
Recent Litigation for AMPHADASE
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals of New York, LLC | 2018-12-19 |
| KYTHERA BIOPHARMACEUTICALS, INC. v. SLAYBACK PHARMA LLC | 2018-11-08 |
| Halozyme, Inc. v. Lee | 2016-12-19 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2017-05-30 | |
| 2017-01-31 |
Pharmacology for AMPHADASE
| 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 AMPHADASE Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for AMPHADASE Derived from Company Disclosures
No patents found based on company disclosures
3) Low Certainty: US Patents for AMPHADASE Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Amphastar Pharmaceuticals, Inc. | AMPHADASE | hyaluronidase | Injection | 021665 | See Plans and Pricing | 2030-09-29 | Patent claims search |
| Amphastar Pharmaceuticals, Inc. | AMPHADASE | hyaluronidase | Injection | 021665 | See Plans and Pricing | 2033-03-11 | Patent claims search |
| Amphastar Pharmaceuticals, Inc. | AMPHADASE | hyaluronidase | Injection | 021665 | See Plans and Pricing | 2023-03-05 | Patent claims search |
| Amphastar Pharmaceuticals, Inc. | AMPHADASE | hyaluronidase | Injection | 021665 | See Plans and Pricing | 2027-04-03 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
