VOSORITIDE - Generic Drug Details
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What are the generic sources for vosoritide and what is the scope of patent protection?
Vosoritide
is the generic ingredient in one branded drug marketed by Biomarin Pharm and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vosoritide has eighty-three patent family members in twenty-six countries.
One supplier is listed for this compound.
Summary for VOSORITIDE
| International Patents: | 83 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 9 |
| Patent Applications: | 45 |
| What excipients (inactive ingredients) are in VOSORITIDE? | VOSORITIDE excipients list |
| DailyMed Link: | VOSORITIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VOSORITIDE
Generic Entry Date for VOSORITIDE*:
Constraining patent/regulatory exclusivity:
TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES Dosage:
POWDER;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VOSORITIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roopa Kanakatti Shankar | Phase 2 |
| UCSF Benioff Children's Hospital Oakland | Phase 1/Phase 2 |
| Andrew Dauber | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for VOSORITIDE
US Patents and Regulatory Information for VOSORITIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-002 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-003 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-002 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-003 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-003 | Nov 19, 2021 | 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 |
EU/EMA Drug Approvals for VOSORITIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| BioMarin International Limited | Voxzogo | vosoritide | EMEA/H/C/005475 Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing. |
Authorised | no | no | yes | 2021-08-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VOSORITIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Croatia | P20240450 | ⤷ Sign Up | |
| European Patent Office | 4406599 | ⤷ Sign Up | |
| European Patent Office | 4029512 | VARIANTES DU PEPTIDE NATRIURÉTIQUE DE TYPE C (VARIANTS OF C-TYPE NATRIURETIC PEPTIDE) | ⤷ Sign Up |
| Russian Federation | 2020123892 | ⤷ Sign Up | |
| Australia | 2016298425 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VOSORITIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2432489 | 301162 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/21/1577 20210901 |
| 2432489 | C20220003 00351 | Estonia | ⤷ Sign Up | PRODUCT NAME: VOSORITIID;REG NO/DATE: EU/1/21/1577 01.09.2021 |
| 2432489 | CA 2022 00004 | Denmark | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE IN ALL FORMS; REG. NO/DATE: EU/1/21/1577 20210901 |
| 2432489 | 22C1004 | France | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE; REGISTRATION NO/DATE: EU/1/21/1577 20210901 |
| 2432489 | C202230004 | Spain | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE; NATIONAL AUTHORISATION NUMBER: EU/1/21/1577; DATE OF AUTHORISATION: 20210826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1577; DATE OF FIRST AUTHORISATION IN EEA: 20210826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
