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KINEVAC Drug Profile
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» See Plans and PricingWhen do Kinevac patents expire, and when can generic versions of Kinevac launch?
Kinevac is a drug marketed by Bracco and is included in one NDA. There is one patent protecting this drug.
This drug has ten patent family members in eight countries.
The generic ingredient in KINEVAC is sincalide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sincalide profile page.
US ANDA Litigation and Generic Entry Outlook for Kinevac
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 16, 2022. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for KINEVAC
| International Patents: | 10 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 1 |
| Patent Applications: | 347 |
| Drug Prices: | Drug price information for KINEVAC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KINEVAC |
| DailyMed Link: | KINEVAC at DailyMed |
Generic Entry Opportunity Date for KINEVAC
Generic Entry Date for KINEVAC*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION |
*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 KINEVAC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Penn State University | N/A |
| Johns Hopkins University | N/A |
| Temple University | N/A |
Recent Litigation for KINEVAC
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BRACCO DIAGNOSTICS INC. v. MAIA PHARMACEUTICALS, INC. | 2017-12-15 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Maia Pharmaceuticals, Inc. | 2018-11-19 |
Pharmacology for KINEVAC
| Drug Class | Cholecystokinin Analog |
Synonyms for KINEVAC
| (3S,6S,9S,15S,18S,21S)-9-((1H-indol-3-yl)methyl)-21-amino-3-(((S)-1-amino-1-oxo-3-phenylpropan-2-yl)carbamoyl)-6,15-bis(2-(methylthio)ethyl)-5,8,11,14,17,20-hexaoxo-18-(4-(sulfooxy)benzyl)-4,7,10,13,16,19-hexaazatricosane-1, |
| (3S,6S,9S,15S,18S,21S)-9-((1H-indol-3-yl)methyl)-21-amino-3-((S)-1-amino-1-oxo-3-phenylpropan-2-ylcarbamoyl)-6,15-bis(2-(methylthio)ethyl)-5,8,11,14,17,20-hexaoxo-18-(4-(sulfooxy)benzyl)-4,7,10,13,16,19-hexaazatricosane-1,23 |
| (3S)-3-[(2S)-2-[(2S)-2-{2-[(2S)-2-[(2S)-2-[(3S)-3-amino-3-formamidopropanoic acid]-3-[4-(sulfooxy)phenyl]propanamido]-4-(methylsulfanyl)butanamido]acetamido}-3-(1H-indol-3-yl)propanamido]-4-(methylsulfanyl)butanamido]-3-{[(1 |
| (3S)-3-[[(2S)-2-[[(2S)-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-amino-4-hydroxy-4-oxobutanoyl]amino]-3-(4-sulfooxyphenyl)propanoyl]amino]-4-methylsulfanylbutanoyl]amino]acetyl]amino]-3-(1H-indol-3-yl)propanoyl]amino]-4-methylsulfany |
| (3S)-3-amino-4-[[(2S)-1-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-amino-1-oxo-3-phenylpropan-2-yl]amino]-3-carboxy-1-oxopropan-2-yl]amino]-4-(methylthio)-1-oxobutan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino |
| (3S)-3-amino-4-[[(2S)-1-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-amino-1-oxo-3-phenylpropan-2-yl]amino]-3-carboxy-1-oxopropan-2-yl]amino]-4-methylsulfanyl-1-oxobutan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]ami |
| (3S)-3-azanyl-4-[[(2S)-1-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-azanyl-1-oxidanylidene-3-phenyl-propan-2-yl]amino]-4-oxidanyl-1,4-bis(oxidanylidene)butan-2-yl]amino]-4-methylsulfanyl-1-oxidanylidene-butan-2-yl]amin |
| (Tyr[SO3H]27)Cholecystokinin fragment 26-33 Amide |
| [125I]CCK-8 |
| 1-De(5-oxo-L-proline)-2-de-L-glutamine-5-L-methioninecaerulein |
| 126S323 |
| 25126-32-3 |
| 3-10-Caerulein, 5-L-methionine- |
| A817659 |
| AKOS015896031 |
| AKOS016340423 |
| Asp-Tyr(SO3H)-Met-Gly-Trp-Met-Asp-Phe-NH2 |
| Asp26-Tyr(SO3H)-Met-Gly-Trp-Met-Asp-PheNH2 |
| BDBM21147 |
| C49H62N10O16S3 |
| Caerulein, 1-de(5-oxo-L-proline)-2-de-L-glutamine-5-L-methionine- |
| CAS-25126-32-3 |
| CCK C-terminal octapeptide |
| CCK-8 |
| CCK-8 (sulphated) |
| CCK-8(SO3) |
| CHEBI:135946 |
| CHEMBL1121 |
| cholecystokinin 8 |
| cholecystokinin C-terminal octapeptide |
| cholecystokinin fragment 26-33 amide (sulphated) |
| Cholecystokinin octapeptide |
| Cholecystokinin Octapeptide, sulfated |
| Cholecystokinin-pancreozymin |
| CS-042 |
| CS-5963 |
| D05845 |
| DB-046634 |
| DB09142 |
| DSSTox_CID_28543 |
| DSSTox_GSID_48617 |
| DSSTox_RID_82815 |
| DTXSID7048617 |
| EINECS 246-639-0 |
| FT-0630515 |
| GTPL864 |
| H-Asp-Tyr(SO3H)-Met-Gly-Trp-Met-Asp-Phe-NH2 |
| HS-2026 |
| Human CCK-8 |
| HY-P0093 |
| IZTQOLKUZKXIRV-YRVFCXMDSA-N |
| Kinevac (TN) |
| L-alpha-Aspartyl-O-sulfo-L-tyrosyl-L-methionylglycyl-L-tryptophyl-L-methionyl-L-alpha-aspartyl-L-phenylalaninamide |
| L-Aspartyl-L-tyrosyl-L-methionylglycyl-L-tryptophyl-L-methionyl-L-aspartylphenyl-L-alaninamide hydrogen sulfate (ester) |
| LS-53094 |
| M03GIQ7Z6P |
| MFCD00079849 |
| NCGC00167273-01 |
| NCGC00183278-01 |
| NCGC00183363-01 |
| O411 |
| Pancreozymin |
| Pancreozymin C-terminal octapeptide |
| Q7521885 |
| SC-47569 |
| SCHEMBL122365 |
| SCHEMBL1425223 |
| Sincalida |
| Sincalida [INN-Spanish] |
| Sincalide |
| Sincalide (Kinevac) |
| Sincalide (USP/INN) |
| Sincalide [USAN:BAN:INN] |
| Sincalide [USAN:USP:INN:BAN] |
| Sincalidum |
| Sincalidum [INN-Latin] |
| SQ 19844 |
| SQ-19844 |
| Syncalide |
| Tox21_112955 |
| Tox21_113481 |
| UNII-M03GIQ7Z6P |
US Patents and Regulatory Information for KINEVAC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bracco | KINEVAC | sincalide | INJECTABLE;INJECTION | 017697-001 | Approved Prior to Jan 1, 1982 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >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 KINEVAC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bracco | KINEVAC | sincalide | INJECTABLE;INJECTION | 017697-001 | Approved Prior to Jan 1, 1982 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KINEVAC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60336509 | Start Trial |
| Japan | S4813114 | Start Trial |
| Germany | 1922185 | Start Trial |
| United Kingdom | 1278681 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
