DrugPatentWatch Database Preview
NUCALA Drug Profile
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UNDER DEVELOPMENT
When do Nucala patents expire, and when can biosimilar versions of Nucala launch?
Nucala is a drug marketed by Glaxosmithkline Llc and Glaxosmithkline and is included in two BLAs.
The biologic ingredient in NUCALA is mepolizumab. A full profile is posted on the mepolizumab profile page.
DrugPatentWatch® Biosimilar and Interchangeable Outlook for Nucala
Indicators of Biosimilar Launch
Summary for Tradename: NUCALA
| Patents: | 46 |
| Applicants: | 2 |
| BLAs: | 2 |
| Suppliers: see list | 1 |
| Recent Clinical Trials: | See clinical trials for NUCALA |
Recent Clinical Trials for NUCALA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| University of Manchester | Phase 4 |
| McMaster University | Phase 4 |
| GlaxoSmithKline | Phase 1 |
Pharmacology for NUCALA
| Mechanism of Action | Interleukin-5 Antagonists |
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 NUCALA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for NUCALA Derived from Company Disclosures
No patents found based on company disclosures
3) Low Certainty: US Patents for NUCALA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Number | Approval Date | Patent No. | Assignee | Estimated Patent Expiration | Status | Orphan | Source |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glaxosmithkline Llc | NUCALA | mepolizumab | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 125526 | 001 | 2015-11-04 | ⤷ Try it Free | Knopp Biosciences LLC (Pittsburgh, PA) | 2033-08-13 | RX | Orphan | search |
| Glaxosmithkline Llc | NUCALA | mepolizumab | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 125526 | 001 | 2015-11-04 | ⤷ Try it Free | DS BIOPHARMA LIMITED (Dublin, IE) | 2035-05-13 | RX | Orphan | search |
| Glaxosmithkline Llc | NUCALA | mepolizumab | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 125526 | 001 | 2015-11-04 | ⤷ Try it Free | CureVac AG (Tubingen, DE) | 2032-02-15 | RX | Orphan | search |
| Glaxosmithkline Llc | NUCALA | mepolizumab | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 125526 | 001 | 2015-11-04 | ⤷ Try it Free | Knopp Biosciences LLC (Pittsburgh, PA) | 2033-08-13 | RX | Orphan | search |
| Glaxosmithkline Llc | NUCALA | mepolizumab | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 125526 | 001 | 2015-11-04 | ⤷ Try it Free | Patheon Softgels, Inc. (High Point, NC) | 2035-06-15 | RX | Orphan | search |
| Glaxosmithkline Llc | NUCALA | mepolizumab | INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER | 125526 | 001 | 2015-11-04 | ⤷ Try it Free | PRAIRIE PHARMACEUTICALS LLC (Bethesda, MD) | 2030-02-08 | RX | Orphan | search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Number | >Approval Date | >Patent No. | >Assignee | >Estimated Patent Expiration | >Status | >Orphan | >Source |
International Patents for NUCALA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2049501 | ⤷ Try it Free |
| European Patent Office | 3838271 | ⤷ Try it Free |
| World Intellectual Property Organization (WIPO) | 2015023786 | ⤷ Try it Free |
| Canada | 2961517 | ⤷ Try it Free |
| Spain | 2554252 | ⤷ Try it Free |
| Japan | 2013231040 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
