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Degarelix acetate - Generic Drug Details
What are the generic sources for degarelix acetate and what is the scope of freedom to operate?
Degarelix acetate
is the generic ingredient in one branded drug marketed by Ferring and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Degarelix acetate has one hundred and thirty-six patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for degarelix acetate
| International Patents: | 136 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 27 |
| Patent Applications: | 12 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | degarelix acetate at DailyMed |
Recent Clinical Trials for degarelix acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ferring Pharmaceuticals | Early Phase 1 |
| Charles G. Drake | Early Phase 1 |
| Bristol-Myers Squibb | Early Phase 1 |
Paragraph IV (Patent) Challenges for DEGARELIX ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FIRMAGON | POWDER;SUBCUTANEOUS | degarelix acetate | 022201 | 2019-12-20 |
US Patents and Regulatory Information for degarelix acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-001 | Dec 24, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ferring | FIRMAGON | degarelix acetate | POWDER;SUBCUTANEOUS | 022201-002 | Dec 24, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for degarelix acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 2505204 | Start Trial |
| Austria | 319736 | Start Trial |
| Luxembourg | 91585 | Start Trial |
| Malaysia | 114811 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for degarelix acetate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1003774 | 91585 | Luxembourg | Start Trial | PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217 |
| 1003774 | 300395 | Netherlands | Start Trial | 300395, 20180413, EXPIRES: 20230412 |
| 1003774 | CA 2009 00022 | Denmark | Start Trial | |
| 1003774 | 362 | Finland | Start Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
