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Goserelin acetate - Generic Drug Details
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What are the generic drug sources for goserelin acetate and what is the scope of freedom to operate?
Goserelin acetate
is the generic ingredient in one branded drug marketed by Tersera and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Goserelin acetate has fifty patent family members in thirty-three countries.
There are five drug master file entries for goserelin acetate. Two suppliers are listed for this compound.
Summary for goserelin acetate
| International Patents: | 50 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 5 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 36 |
| Clinical Trials: | 107 |
| Patent Applications: | 7,673 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in goserelin acetate? | goserelin acetate excipients list |
| DailyMed Link: | goserelin acetate at DailyMed |
Recent Clinical Trials for goserelin acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| Wonju Severance Christian Hospital | Phase 4 |
| Eulji University Hospital | Phase 4 |
Pharmacology for goserelin acetate
| Drug Class | Gonadotropin Releasing Hormone Receptor Agonist |
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for goserelin acetate
US Patents and Regulatory Information for goserelin acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 019726-001 | Dec 29, 1989 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 019726-001 | Dec 29, 1989 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 019726-001 | Dec 29, 1989 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | RX | Yes | Yes | 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 |
Expired US Patents for goserelin acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 019726-001 | Dec 29, 1989 | Start Trial | Start Trial |
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | Start Trial | Start Trial |
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | Start Trial | Start Trial |
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | Start Trial | Start Trial |
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 019726-001 | Dec 29, 1989 | Start Trial | Start Trial |
| Tersera | ZOLADEX | goserelin acetate | IMPLANT;IMPLANTATION | 020578-001 | Jan 11, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for goserelin acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ukraine | 75351 | Start Trial |
| Spain | 2273803 | Start Trial |
| South Africa | 200205478 | Start Trial |
| Taiwan | 500616 | Start Trial |
| Japan | 4875741 | Start Trial |
| Portugal | 1259274 | Start Trial |
| >Country | >Patent 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 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.
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