KEYTRUDA Drug Profile
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Summary for Tradename: KEYTRUDA
| High Confidence Patents: | 0 |
| Applicants: | 1 |
| BLAs: | 1 |
| Recent Clinical Trials: | See clinical trials for KEYTRUDA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KEYTRUDA |
Recent Clinical Trials for KEYTRUDA
Identify potential brand extensions & biosimilar entrants
| Sponsor | Phase |
|---|---|
| Regeneron Pharmaceuticals | Phase 2/Phase 3 |
| Dartmouth-Hitchcock Medical Center | Phase 1/Phase 2 |
| James Isaacs, MD | Phase 1 |
Recent Litigation for KEYTRUDA
Identify key patents and potential future biosimilar entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Alnylam Pharmaceuticals, Inc. v. Moderna, Inc. | 2022-03-17 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Genome & Company | 2018-10-02 |
Pharmacology for KEYTRUDA
| Mechanism of Action | Programmed Death Receptor-1-directed Antibody Interactions |
| Established Pharmacologic Class | Programmed Death Receptor-1 Blocking Antibody |
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 KEYTRUDA Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for KEYTRUDA Derived from Company Disclosures
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | Company disclosures | |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2028-06-13 | Company disclosures |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2032-12-19 | Company disclosures |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2034-12-19 | Company disclosures |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | Injection | 125514 | ⤷ Sign Up | Company disclosures | |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
3) Low Certainty: US Patents for KEYTRUDA Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2035-06-26 | Patent claims search |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2034-02-06 | Patent claims search |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2034-10-30 | Patent claims search |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2034-06-17 | Patent claims search |
| Merck Sharp & Dohme Llc | KEYTRUDA | pembrolizumab | For Injection | 125514 | ⤷ Sign Up | 2035-05-04 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
