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Degarelix acetate - Generic Drug Details
What are the generic sources for degarelix acetate and what is the scope of patent protection?
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 |
|---|---|
| Charles G. Drake | Early Phase 1 |
| Bristol-Myers Squibb | Early Phase 1 |
| Ferring Pharmaceuticals | 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 | 022201-001 | 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 | 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 |
|---|---|---|
| Mexico | 2010008817 | Start Trial |
| Russian Federation | 2504394 | 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 | 122009000033 | Germany | Start Trial | PRODUCT NAME: DEGARELIX, GGF. IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON, WIE DEM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001-002 20090217 |
| 1003774 | PA2009005 | Lithuania | Start Trial | PRODUCT NAME: DEGARELIXUM ACETAT; REGISTRATION NO/DATE: EU/1/08/504/001, 2009 02 17 EU/1/08/504/002 20090217 |
| 1003774 | 91585 | Luxembourg | Start Trial | PRODUCT NAME: DEGARELIX, EVENTUELLEMENT UN SEL PHARMACEUTIQUEMENT ACCEPTABE, TEL QUE L'ACETATE (FIRMAGON); REG. DATE: 20090217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
