GAMMAKED, GAMUNEX-C Drug Profile
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Summary for Tradename: GAMMAKED, GAMUNEX-C
| High Confidence Patents: | 5 |
| Applicants: | 1 |
| BLAs: | 1 |
Pharmacology for GAMMAKED, GAMUNEX-C
| Mechanism of Action | Antigen Neutralization |
| Physiological Effect | Passively Acquired Immunity |
| Established Pharmacologic Class | Human Immunoglobulin G |
| Chemical Structure | Immunoglobulins |
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
- DrugPatentWatch analysis and company 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 various sources, including 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 GAMMAKED, GAMUNEX-C Derived from Brand-Side Litigation
No patents found based on brand-side litigation
2) High Certainty: US Patents for GAMMAKED, GAMUNEX-C Derived from DrugPatentWatch Analysis and Company Disclosures
3) Low Certainty: US Patents for GAMMAKED, GAMUNEX-C Derived from Patent Text Search
| Applicant | Tradename | Biologic Ingredient | Dosage Form | BLA | Patent No. | Estimated Patent Expiration | Source |
|---|---|---|---|---|---|---|---|
| Grifols Therapeutics Llc | GAMMAKED, GAMUNEX-C | immune globulin injection (human) 10% caprylate/chromatography purified | Injection | 125046 | ⤷ Start Trial | 2035-11-09 | Patent claims search |
| Grifols Therapeutics Llc | GAMMAKED, GAMUNEX-C | immune globulin injection (human) 10% caprylate/chromatography purified | Injection | 125046 | ⤷ Start Trial | 2010-03-30 | Patent claims search |
| Grifols Therapeutics Llc | GAMMAKED, GAMUNEX-C | immune globulin injection (human) 10% caprylate/chromatography purified | Injection | 125046 | ⤷ Start Trial | 2021-03-22 | Patent claims search |
| Grifols Therapeutics Llc | GAMMAKED, GAMUNEX-C | immune globulin injection (human) 10% caprylate/chromatography purified | Injection | 125046 | ⤷ Start Trial | 2028-07-03 | Patent claims search |
| >Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Patent No. | >Estimated Patent Expiration | >Source |
International Patents for GAMMAKED, GAMUNEX-C
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | E448323 | ⤷ Start Trial |
| Australia | 2004218354 | ⤷ Start Trial |
| Australia | 2006216545 | ⤷ Start Trial |
| Australia | 2009245838 | ⤷ Start Trial |
| Australia | 2013202475 | ⤷ Start Trial |
| Brazil | PI0408116 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GAMMAKED, GAMUNEX-C
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 132020000000055 | Italy | ⤷ Start Trial | PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925 |
| CA 2017 00004 | Denmark | ⤷ Start Trial | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
| 2016C/068 | Belgium | ⤷ Start Trial | PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121 |
| 61/2015 | Austria | ⤷ Start Trial | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527 |
| 132017000002735 | Italy | ⤷ Start Trial | PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO E DARUNAVIR O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO(REZOLSTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/967, 20141121 |
| SPC/GB20/024 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: COBICISTAT, OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/17/1225(NI) 20170925; UK PLGB00242/0664 20170925 |
| >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
