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NETSPOT Drug Profile
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When do Netspot patents expire, and what generic alternatives are available?
Netspot is a drug marketed by Aaa Usa Inc and is included in one NDA. There is one patent protecting this drug.
This drug has twenty-six patent family members in nineteen countries.
The generic ingredient in NETSPOT is gallium dotatate ga-68. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium dotatate ga-68 profile page.
US ANDA Litigation and Generic Entry Outlook for Netspot
Netspot will be eligible for patent challenges on June 1st, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 10th, 2032. This may change due to patent challenges or generic licensing.
Summary for NETSPOT
| International Patents: | 26 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| DailyMed Link: | NETSPOT at DailyMed |
Generic Entry Opportunity Date for NETSPOT
Generic Entry Date for NETSPOT*:
Constraining patent/regulatory exclusivity:
NDA:
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 NETSPOT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Phase 3 |
| University of Alabama at Birmingham | Early Phase 1 |
| West Virginia University | Phase 2 |
US Patents and Regulatory Information for NETSPOT
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Aaa Usa Inc | NETSPOT | gallium dotatate ga-68 | POWDER;INTRAVENOUS | 208547-001 | Jun 1, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Aaa Usa Inc | NETSPOT | gallium dotatate ga-68 | POWDER;INTRAVENOUS | 208547-001 | Jun 1, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 NETSPOT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2742017 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2013024013 | Start Trial |
| Japan | 2014524423 | Start Trial |
| Israel | 230904 | Start Trial |
| India | 1897CHN2014 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
