DrugPatentWatch Database Preview
Leuprolide acetate - Generic Drug Details
What are the generic drug sources for leuprolide acetate and what is the scope of patent protection?
Leuprolide acetate
is the generic ingredient in eight branded drugs marketed by Gp-pharm Sa, Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharm, Teva Pharms Usa, Abbvie Endocrine Inc, Tolmar Therap, and Abbvie Endocrine, and is included in seventeen NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Leuprolide acetate has one hundred and ninety-four patent family members in forty-two countries.
There are twenty-two drug master file entries for leuprolide acetate. Four suppliers are listed for this compound.
Summary for leuprolide acetate
| International Patents: | 194 |
| US Patents: | 9 |
| Tradenames: | 8 |
| Applicants: | 9 |
| NDAs: | 17 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 45 |
| Clinical Trials: | 115 |
| Patent Applications: | 8,027 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for leuprolide acetate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for leuprolide acetate |
| DailyMed Link: | leuprolide acetate at DailyMed |
Recent Clinical Trials for leuprolide acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | Phase 4 |
| Stanford University | Phase 2 |
| University of North Carolina, Chapel Hill | Phase 2 |
Recent Litigation for leuprolide acetate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Horatio Washington Depot Technologies LLC v. Tolmar, Inc. | 2017-08-03 |
| SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC. | 2015-01-16 |
| Ferring B v. v. Watson Laboratories Inc. | 2014-04-17 |
Medical Subject Heading (MeSH) Categories for leuprolide acetate
Synonyms for leuprolide 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 |
| AK322237 |
| 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 |
| Lupron |
| Lutrate |
| 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 |
Paragraph IV (Patent) Challenges for LEUPROLIDE ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LUPRON DEPOT | INJECTABLE;INJECTION | leuprolide acetate | 019732 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-005 | Jan 21, 1994 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sandoz | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 074728-001 | Aug 4, 1998 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tolmar Therap | ELIGARD | leuprolide acetate | INJECTABLE;SUBCUTANEOUS | 021488-001 | Feb 13, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 |
Expired US Patents for leuprolide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ortho Mcneil Janssen | VIADUR | leuprolide acetate | IMPLANT;IMPLANTATION | 021088-001 | Mar 3, 2000 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-005 | Jan 21, 1994 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-002 | Apr 16, 1993 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED | leuprolide acetate | INJECTABLE;INJECTION | 020263-005 | Jan 21, 1994 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for leuprolide acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 234608 | Start Trial |
| China | 100348265 | Start Trial |
| Germany | 69914787 | Start Trial |
| Brazil | PI0008197 | Start Trial |
| Mexico | PA03011456 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
