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LUTRATE DEPOT KIT Drug Profile
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» See Plans and PricingWhich patents cover Lutrate Depot Kit, and when can generic versions of Lutrate Depot Kit launch?
Lutrate Depot Kit is a drug marketed by Gp-pharm Sa and is included in one NDA. There is one patent protecting this drug.
This drug has sixteen patent family members in twelve countries.
The generic ingredient in LUTRATE DEPOT KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
US ANDA Litigation and Generic Entry Outlook for Lutrate Depot Kit
A generic version of LUTRATE DEPOT KIT was approved as leuprolide acetate by SANDOZ on August 4th, 1998.
Summary for LUTRATE DEPOT KIT
| International Patents: | 16 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LUTRATE DEPOT KIT at DailyMed |
Recent Clinical Trials for LUTRATE DEPOT KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
US Patents and Regulatory Information for LUTRATE DEPOT KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gp-pharm Sa | LUTRATE DEPOT KIT | leuprolide acetate | FOR SUSPENSION;INTRAMUSCULAR | 205054-001 | Aug 28, 2018 | DISCN | Yes | No | Start Trial | Start Trial | Y | 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 LUTRATE DEPOT KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 0008197 | Start Trial |
| Spain | 2169980 | Start Trial |
| Japan | 2003516960 | Start Trial |
| Japan | 5021880 | Start Trial |
| Denmark | 1151746 | Start Trial |
| Brazil | PI0008197 | Start Trial |
| Australia | 2173501 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
