GANIRELIX ACETATE - Generic Drug Details
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What are the generic sources for ganirelix acetate and what is the scope of freedom to operate?
Ganirelix acetate
is the generic ingredient in two branded drugs marketed by Sun Pharm, Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for ganirelix acetate. Eight suppliers are listed for this compound.
Summary for GANIRELIX ACETATE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 22 |
| Patent Applications: | 295 |
| Drug Prices: | Drug price trends 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Amphastar Pharms Inc | GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 212613-001 | Apr 7, 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 | |||
| Sun Pharm | FYREMADEL | ganirelix acetate | INJECTABLE;INJECTION | 204246-001 | Nov 30, 2018 | 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 | |||
| >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 |
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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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