LUPRON DEPOT-PED KIT Drug Patent Profile
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Which patents cover Lupron Depot-ped Kit, and what generic alternatives are available?
Lupron Depot-ped Kit is a drug marketed by Abbvie Endocrine Inc and is included in one NDA. There are two patents protecting this drug.
This drug has thirty-five patent family members in twenty-eight countries.
The generic ingredient in LUPRON DEPOT-PED KIT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lupron Depot-ped Kit
A generic version of LUPRON DEPOT-PED KIT was approved as leuprolide acetate by SANDOZ on August 4th, 1998.
Summary for LUPRON DEPOT-PED KIT
| International Patents: | 35 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 132 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LUPRON DEPOT-PED KIT at DailyMed |
Recent Clinical Trials for LUPRON DEPOT-PED KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 4 |
| Emory University | Phase 4 |
| Syneos Health | Phase 2 |
US Patents and Regulatory Information for LUPRON DEPOT-PED KIT
LUPRON DEPOT-PED KIT is protected by two US patents and one FDA Regulatory Exclusivity.
Patents protecting LUPRON DEPOT-PED KIT
Sustained-release composition and method for producing the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Sustained-release composition and method for producing the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PEDIATRIC PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY
FDA Regulatory Exclusivity protecting LUPRON DEPOT-PED KIT
NEW STRENGTH
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-003 | Apr 16, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-008 | Aug 15, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-005 | Jan 21, 1994 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-009 | Apr 14, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-002 | Apr 16, 1993 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for LUPRON DEPOT-PED KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-006 | Jan 21, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-004 | Apr 16, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-008 | Aug 15, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-005 | Jan 21, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-004 | Apr 16, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LUPRON DEPOT-PED KIT
See the table below for patents covering LUPRON DEPOT-PED KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2125953 | ⤷ Try a Trial | |
| Hong Kong | 3792 | METHOD FOR PRODUCING MICROCAPSULE | ⤷ Try a Trial |
| Australia | 8179491 | ⤷ Try a Trial | |
| Ireland | 68436 | Prolonged release microcapsules | ⤷ Try a Trial |
| Singapore | 108191 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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