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XADAGO Drug Profile
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» See Plans and PricingWhen do Xadago patents expire, and when can generic versions of Xadago launch?
Xadago is a drug marketed by Us Worldmeds Llc and is included in one NDA. There are three patents protecting this drug.
This drug has ninety-seven patent family members in thirty-one countries.
The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
US ANDA Litigation and Generic Entry Outlook for Xadago
Xadago will be eligible for patent challenges on March 21, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 10, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for XADAGO
| International Patents: | 97 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 58 |
| Clinical Trials: | 4 |
| Patent Applications: | 208 |
| Drug Prices: | Drug price information for XADAGO |
| DailyMed Link: | XADAGO at DailyMed |
Generic Entry Opportunity Date for XADAGO
Generic Entry Date for XADAGO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*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 XADAGO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alain Kaelin | Phase 4 |
| Clinical Trial Unit Ente Ospedaliero Cantonale | Phase 4 |
| IRCCS San Raffaele | Phase 4 |
Pharmacology for XADAGO
| Drug Class | Monoamine Oxidase Type B Inhibitor |
| Mechanism of Action | Monoamine Oxidase-B Inhibitors Breast Cancer Resistance Protein Inhibitors |
Synonyms for XADAGO
| (+-)-(S)-2-((p-((m-Fluorobenzyl)oxy)benzyl)amino)propionamide |
| (2S)-2-[({4-[(3-fluorophenyl)methoxy]phenyl}methyl)amino]propanamide |
| (2S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methylamino]propanamide |
| (2S)-2-[4-(3-fluorobenzyloxy)benzylamino]propionamide |
| (5)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide |
| (S)-(+)-2-[4-(3-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDE METHANSULFONATE |
| (S)-2-(((4-((3-Fluorophenyl)methoxy)phenyl)methyl)amino)propanamide |
| (S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)amino)propanamide |
| (S)-2-[[4-[(3-Fluorobenzyl)oxy]benzyl]amino]propanamide |
| (S)-2-[[4-[(3-Fluorobenzyl)oxy]benzyl]amino]propionamide |
| (S)-2-[4-(3-Fluoro-benzyloxy)-benzylamino]-propionamide; compound with methanesulfonic acid |
| (S)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide |
| (S)-2[4-(3-fluorobenzyloxy)benzylamino] propanamide |
| (S)-2[4-(3-fluorobenzyloxy)benzylamino]propanamide |
| 133865-89-1 |
| 2-(4-(3-Fluorobenzyloxy)benzylamino)propionamide |
| 2(s)-(4-(3-fluorobenzyloxy)benzylamino)propionamide |
| 2(S)-[4-(3-Fluorobenzyloxy) benzylamino] propionamide |
| 6135AA |
| 90ENL74SIG |
| AC-26829 |
| AK-77847 |
| AKOS016002015 |
| ANW-58666 |
| API0009223 |
| AX8150732 |
| BCP12082 |
| BDBM19187 |
| BDBM50078694 |
| CHEBI:134718 |
| CHEMBL396778 |
| CHEMBL48582 |
| CS-0556 |
| CTK8B7808 |
| D10158 |
| DB06654 |
| DTXSID601010282 |
| EC 603-772-2 |
| EMD 1195686 |
| EMD-1195686 |
| ER-0076 |
| EX-A2759 |
| Fce-26743 |
| FT-0700949 |
| GTPL8291 |
| HY-70057 |
| J-506604 |
| N2-(4-((3-Fluorbenzyl)oxy)benzyl)-L-alaninamid |
| NCGC00346529-01 |
| NEMGRZFTLSKBAP-LBPRGKRZSA-N |
| P111001 |
| Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (S)- |
| Q2211523 |
| S0935 |
| s5357 |
| Safinamide |
| Safinamide (USAN/INN) |
| Safinamide [USAN:INN] |
| Safinamide mesylate Intermediate 2 |
| SB16691 |
| SC-89769 |
| SCHEMBL69350 |
| ST24035822 |
| TC-147411 |
| UNII-90ENL74SIG |
| W-5197 |
| ZINC53084692 |
US Patents and Regulatory Information for XADAGO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Us Worldmeds Llc | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Us Worldmeds Llc | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Us Worldmeds Llc | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | RX | Yes | No | 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 XADAGO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1109295 | Start Trial |
| Serbia | 55464 | Start Trial |
| Eurasian Patent Organization | 200970028 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for XADAGO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613296 | 132016000023012 | Italy | Start Trial | PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224 |
| 1613296 | 46/2015 | Austria | Start Trial | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
| 1613296 | CR 2015 00042 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
