GALLIUM DOTATATE GA-68 - Generic Drug Details
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What are the generic sources for gallium dotatate ga-68 and what is the scope of patent protection?
Gallium dotatate ga-68
is the generic ingredient in one branded drug marketed by Aaa Usa Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Gallium dotatate ga-68 has thirty-two patent family members in nineteen countries.
One supplier is listed for this compound.
Summary for GALLIUM DOTATATE GA-68
| International Patents: | 32 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 16 |
| DailyMed Link: | GALLIUM DOTATATE GA-68 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GALLIUM DOTATATE GA-68
Generic Entry Date for GALLIUM DOTATATE GA-68*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for GALLIUM DOTATATE GA-68
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
| First Affiliated Hospital of Fujian Medical University | Early Phase 1 |
| Peking Union Medical College Hospital | Early Phase 1 |
US Patents and Regulatory Information for GALLIUM DOTATATE GA-68
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aaa Usa Inc | NETSPOT | gallium dotatate ga-68 | POWDER;INTRAVENOUS | 208547-001 | Jun 1, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for GALLIUM DOTATATE GA-68
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2014001691 | PROCEDIMIENTO PARA LA PREPARACION DE COMPLEJOS DE 68GA. (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA.) | ⤷ Try a Trial |
| Israel | 275979 | תהליך להכנת קומפלקסים של 68ga (Process for the preparation of complexes of 68ga) | ⤷ Try a Trial |
| Mexico | 370081 | PROCEDIMIENTO PARA LA PREPARACION DE COMPLEJOS DE 68GA. (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA.) | ⤷ Try a Trial |
| Israel | 245849 | תהליך להכנת איזוטופ קומפלקסים של 68ga (Process for the preparation of complexes of 68ga.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
