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Leuprolide acetate - Generic Drug Details
What are the generic drug sources for leuprolide acetate and what is the scope of leuprolide acetate freedom to operate?
Leuprolide acetate
is the generic ingredient in eight branded drugs marketed by Gp-pharm Sa, Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharma Global, Teva Pharms Usa, Abbvie Endocrine Inc, Tolmar Therap, and Abbvie Endocrine, and is included in seventeen NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are twenty-two drug master file entries for leuprolide acetate. Five suppliers are listed for this compound.
Summary for leuprolide acetate
| US Patents: | 16 |
| Tradenames: | 8 |
| Applicants: | 9 |
| NDAs: | 17 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 36 |
| Clinical Trials: | 108 |
| Patent Applications: | 7,575 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for leuprolide acetate |
| DailyMed Link: | leuprolide acetate at DailyMed |
Pharmacology for leuprolide acetate
| Drug Class | Gonadotropin Releasing Hormone Receptor Agonist |
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for leuprolide acetate
Synonyms for leuprolide acetate
| (Des-Gly10,D-Leu6,Pro-NHEt9)-LHRH acetate |
| 381L536 |
| 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tryosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide monoacetate |
| 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide--acetic acid (1/1) |
| 53714-56-0 |
| 74381-53-6 |
| 743L536 |
| A-43818 |
| Abbott-43818 |
| AC-28731 |
| AC1LCW5G |
| AKOS015895632 |
| AKOS030485977 |
| Carcinil |
| CAS-74381-53-6 |
| CHEBI:63597 |
| CHEMBL1200775 |
| CS-1434 |
| des-Gly10-[D-Leu6]-LH-RH ethylamide |
| DSSTox_CID_28935 |
| DSSTox_GSID_49009 |
| DSSTox_RID_83201 |
| DTXSID7049009 |
| Enanton |
| Enantone |
| FT-0627807 |
| HY-13665 |
| L0249 |
| Leuprolide acetate salt |
| Leuprorelin acetate |
| Leuprorelinacetate |
| Lupron |
| Lutrate |
| MFCD00072080 |
| MFCD00167544 |
| MLS000028695 |
| NCGC00183364-01 |
| Onectyl |
| Prostap |
| Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt.HOAc |
| RGLRXNKKBLIBQS-XNHQSDQCSA-N |
| SCHEMBL3174 |
| SMR000058945 |
| TAP-144 |
| Tox21_113507 |
US Patents and Regulatory Information for leuprolide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie Endocrine | LUPANETA PACK | leuprolide acetate; norethindrone acetate | INJECTABLE, TABLET;INTRAMUSCULAR, ORAL | 203696-001 | Dec 14, 2012 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Abbvie Endocrine Inc | LUPRON | leuprolide acetate | INJECTABLE;INJECTION | 019010-001 | Apr 9, 1985 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-004 | Apr 16, 1993 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | DISCN | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free 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 leuprolide acetate
International Patents for leuprolide acetate
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Argentina | 064381 | ➤ Try a Free Trial |
| Hong Kong | 1141459 | ➤ Try a Free Trial |
| Brazil | PI0114069 | ➤ Try a Free Trial |
| Denmark | 1151746 | ➤ Try a Free Trial |
| Germany | 69836149 | ➤ Try a Free Trial |
| Israel | 159059 | ➤ Try a Free Trial |
| Country | Document Number | 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 verifification 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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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