GANIRELIX ACETATE Drug Patent Profile
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Which patents cover Ganirelix Acetate, and when can generic versions of Ganirelix Acetate launch?
Ganirelix Acetate is a drug marketed by Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon. and is included in five NDAs.
The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ganirelix Acetate
A generic version of GANIRELIX ACETATE was approved as ganirelix acetate by ORGANON USA ORGANON on July 29th, 1999.
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Summary for GANIRELIX ACETATE
| US Patents: | 0 |
| Applicants: | 5 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 22 |
| Patent Applications: | 124 |
| Drug Prices: | Drug price information for GANIRELIX ACETATE |
| What excipients (inactive ingredients) are in GANIRELIX ACETATE? | GANIRELIX ACETATE excipients list |
| DailyMed Link: | GANIRELIX ACETATE at DailyMed |
Recent Clinical Trials for GANIRELIX ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Instituto Bernabeu | Phase 4 |
| Jiangsu HengRui Medicine Co., Ltd. | Phase 3 |
| Yale University | N/A |
Pharmacology for GANIRELIX ACETATE
| Drug Class | Gonadotropin Releasing Hormone Receptor Antagonist |
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Antagonists |
| Physiological Effect | Decreased GnRH Secretion |
Anatomical Therapeutic Chemical (ATC) Classes for GANIRELIX ACETATE
Paragraph IV (Patent) Challenges for GANIRELIX ACETATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| GANIRELIX ACETATE | Injection | ganirelix acetate | 250 mcg/0.5 mL, 1 mL PFS | 021057 | 1 | 2012-03-30 |
US Patents and Regulatory Information for GANIRELIX ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amphastar Pharms Inc | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 212613-001 | Apr 7, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Meitheal | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 214996-001 | Jun 6, 2022 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 215658-001 | Feb 28, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lupin Ltd | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 216075-001 | Nov 16, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Organon Usa Organon | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 021057-001 | Jul 29, 1999 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 GANIRELIX ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Organon Usa Organon | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 021057-001 | Jul 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Usa Organon | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 021057-001 | Jul 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Organon Usa Organon | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 021057-001 | Jul 29, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GANIRELIX ACETATE
See the table below for patents covering GANIRELIX ACETATE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Denmark | 57288 | ⤷ Sign Up | |
| New Zealand | 223403 | LUTEINISING HORMONE RELEASING HORMONE (LHRH, GNRH) ANTAGONISTS AND PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Denmark | 0994718 | ⤷ Sign Up | |
| South Africa | 8800795 | ⤷ Sign Up | |
| Ireland | 880298 | ⤷ Sign Up | |
| Ireland | 63707 | Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists | ⤷ Sign Up |
| Hungary | T63855 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GANIRELIX ACETATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0277829 | 27/2000 | Austria | ⤷ Sign Up | PRODUCT NAME: GANIRELIX ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517 |
| 0277829 | 2000C/030 | Belgium | ⤷ Sign Up | PRODUCT NAME: GANIRELIX; REGISTRATION NO/DATE: EU/1/00/130/001 20000518 |
| 0277829 | C300016 | Netherlands | ⤷ Sign Up | PRODUCT NAME: GANIRELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/00/130/001-002 20000517 |
| 0277829 | SPC/GB00/024 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GANIRELIX OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/130/001 20000517; UK EU/1/00/130/002 20000517 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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