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AGGRASTAT Drug Profile
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See Plans and PricingWhich patents cover Aggrastat, and when can generic versions of Aggrastat launch?
Aggrastat is a drug marketed by Medicure and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has twelve patent family members in six countries.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Aggrastat
Aggrastat was eligible for patent challenges on May 14, 2002.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 1, 2023. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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.
There is one tentative approval for the generic drug (tirofiban hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for AGGRASTAT
| International Patents: | 12 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 56 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,112 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AGGRASTAT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AGGRASTAT |
| DailyMed Link: | AGGRASTAT at DailyMed |
Generic Entry Opportunity Date for AGGRASTAT
Generic Entry Dates for AGGRASTAT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION |
Generic Entry Dates for AGGRASTAT*:
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 AGGRASTAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| David Hasan | Phase 1/Phase 2 |
| University Hospital Inselspital, Berne | Phase 4 |
| Second Hospital of Jilin University | Phase 4 |
Recent Litigation for AGGRASTAT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| MEDICURE INTERNATIONAL, INC. v. GLAND PHARMA LTD. | 2018-11-16 |
Pharmacology for AGGRASTAT
| Drug Class | Platelet Aggregation Inhibitor |
| Physiological Effect | Decreased Platelet Aggregation |
Synonyms for AGGRASTAT
| (2S)-2-(butane-1-sulfonamido)-3-{4-[4-(piperidin-4-yl)butoxy]phenyl}propanoic acid |
| (2S)-2-(butylsulfonylamino)-3-[4-(4-piperidin-4-ylbutoxy)phenyl]propanoic acid |
| (2S)-2-(BUTYLSULFONYLAMINO)-3-[4-[4-(4-PIPERIDYL)BUTOXY]PHENYL]PROPANOIC ACID |
| (2S)-2-(Butylsulfonylamino)-3-{4-[4-(4-piperidyl)butoxy}phenyl propanoic acid |
| (S)-2-(butylsulfonamido)-3-(4-(4-(piperidin-4-yl)butoxy)phenyl)propanoic acid |
| 140430-EP2277565A2 |
| 140430-EP2277566A2 |
| 140430-EP2277567A1 |
| 140430-EP2277568A2 |
| 140430-EP2277569A2 |
| 140430-EP2277570A2 |
| 140430-EP2292280A1 |
| 142373-60-2 (hydrochloride) |
| 144494-65-5 |
| 151065-53-1 |
| 494T655 |
| AB1009554 |
| AC1L1U7O |
| AC1Q6VFB |
| AGG |
| Agrastat (TN) |
| AK546550 |
| AKOS015894972 |
| AN-31474 |
| API0005653 |
| AS-35267 |
| AX8154227 |
| BCP06642 |
| BDBM50004058 |
| BIDD:GT0363 |
| BRD-K37872686-311-01-6 |
| C07965 |
| C22H36N2O5S |
| CHEBI:9605 |
| CHEMBL916 |
| COKMIXFXJJXBQG-NRFANRHFSA-N |
| CS-2829 |
| D08607 |
| DB00775 |
| DTXSID20162730 |
| EBD44261 |
| FT-0773940 |
| GGX234SI5H |
| GTPL6586 |
| HSDB 7323 |
| HY-17369B |
| J-524973 |
| KB-269052 |
| KS-00000H6G |
| L-700,462 |
| L-700462 |
| L-Tyrosine, N-(butylsulfonyl)-O-(4-(4-piperidinyl)butyl)- |
| L700462;MK383 |
| LS-173214 |
| MK-383 |
| MolPort-006-167-632 |
| N-(Butylsulfonyl)-O-(4-(4-piperidyl)butyl)-L-tyrosine |
| N-(butylsulfonyl)-O-(4-piperidin-4-ylbutyl)-L-tyrosine |
| N-(BUTYLSULFONYL)-O-[4-(4-PIPERIDINYL)BUTYL]-L-TYROSINE |
| n-(butylsulfonyl)-o-[4-(piperidin-4-yl)butyl]-l-tyrosine |
| N-(n-butanesulfonyl)-O-(4-(4-piperidinyl)-butyl)-(s)-tyrosine |
| NCGC00263584-02 |
| RL01804 |
| s3085 |
| SC-96683 |
| SCHEMBL3685 |
| tirofiban |
| Tirofiban (INN) |
| Tirofiban [BAN:INN] |
| Tirofiban [INN:BAN] |
| tirofiban hydrochloride (monohydrate) |
| Tirofiban, >=98.5% (HPLC) |
| tirofibanum |
| UNII-GGX234SI5H |
| ZINC3806104 |
Paragraph IV (Patent) Challenges for AGGRASTAT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AGGRASTAT | INJECTABLE;INJECTION | tirofiban hydrochloride | 020913 | 2019-08-29 |
| AGGRASTAT | INJECTABLE;INJECTION | tirofiban hydrochloride | 020913 | 2018-10-03 |
US Patents and Regulatory Information for AGGRASTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-002 | May 17, 2002 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-001 | May 14, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-001 | May 14, 1998 | DISCN | No | 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 |
Expired US Patents for AGGRASTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | Start Trial | Start Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-003 | Apr 20, 2000 | Start Trial | Start Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | Start Trial | Start Trial |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020913-003 | Apr 20, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AGGRASTAT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| United Kingdom | 9809793 | Start Trial |
| Australia | 740941 | Start Trial |
| Canada | 2483929 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9938827 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AGGRASTAT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0478363 | C990040 | Netherlands | Start Trial | PRODUCT NAME: TIROFIBAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN HYDRAAT, IN HET BIJZONDER TIROFIBANHY- DROCHLORIDE MONOHYDRAAT; NATL REGISTRATION NO/DATE: RVG 23380-1 19990707; FIRST REGISTRATION: DE 42618.00.00-01 19980630 |
| 0478363 | 48/1999 | Austria | Start Trial | PRODUCT NAME: TIROFIBAN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-23140 UND 1-23141 19990714; FIRST REGISTRATION: LI IKS-NR 54761 19980528 |
| 0478363 | SPC/GB99/042 | United Kingdom | Start Trial | PRODUCT NAME: TIROFIBAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE HYDROCHLORIDE; REGISTERED: LI 54761 19980528; CH 54761 19980528; DE 42618.00.00 19980630; DE 42618.00.01 19980630; DE 42620.00.00 19980630; DE 42620.00.01 19980630; UK PL 00025/0375 19990715; UK PL 00025/0376 19990715 |
| 0478363 | 2000C/002 | Belgium | Start Trial | PRODUCT NAME: TIROFIBANUM HYDROCHLORIDUM (EQ. TIROFIBAN); NAT. REGISTRATION NO/DATE: 922 IS 191 F 12 19990906; FIRST REGISTRATION: CH 54761 19980528 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
