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GILOTRIF Drug Profile
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When do Gilotrif patents expire, and what generic alternatives are available?
Gilotrif is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty patent family members in forty-six countries.
The generic ingredient in GILOTRIF is afatinib dimaleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.
US ANDA Litigation and Generic Entry Outlook for Gilotrif
Gilotrif was eligible for patent challenges on July 12th, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 19th, 2029. This may change due to patent challenges or generic licensing.
There have been five 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.
Summary for GILOTRIF
| International Patents: | 180 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 13 |
| Patent Applications: | 5 |
| Drug Prices: | Drug price information for GILOTRIF |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GILOTRIF |
| DailyMed Link: | GILOTRIF at DailyMed |
Generic Entry Opportunity Date for GILOTRIF
Generic Entry Date for GILOTRIF*:
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 GILOTRIF
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanderbilt-Ingram Cancer Center | Phase 1 |
| National Cancer Centre, Singapore | Phase 1 |
| Boehringer Ingelheim | Phase 1 |
Recent Litigation for GILOTRIF
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. TEVA PHARMACEUTICALS USA, INC. | 2017-11-10 |
| BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. SANDOZ, INC. | 2017-10-20 |
| BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. SUN PHARMACEUTICAL INDUSTRIES LTD. | 2017-10-20 |
Pharmacology for GILOTRIF
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for GILOTRIF
| (2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate) |
| (2E)-N-(4-[(3-chloro-4-fluorophenyl)amino]-7-{[(3S |
| (2E)-N-(4-[(3-chloro-4-fluorophenyl)amino]-7-{[(3S)-tetrahydrofuran-3-yl]oxy}quinazolin-6-yl)-4-(dimethylamino)but-2-enamide |
| (2E)-N-{4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-tetrahydrofuran-3-yloxy]quinazolin-6-yl}-4-(dimethylamino)but-2-enamide di[(2Z)-but-2-enedioate] |
| (E)-4-Dimethylamino-But-2-Enoic Acid-(4-(3-Chloro-4-Fluoro-Phenylamino)-7-((S)-Tetra-Hydrofuran-3-Yloxy)-Quinazolin-6Yl)-Amide Dimaleate |
| (Z)-but-2-enedioic acid;(E)-N-[4-(3-chloro-4-fluoroanilino)-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide |
| 2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydro-3-furanyl)oxy)- 6-quinazolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:2) |
| 850140-73-7 |
| AC-26080 |
| ACN-043929 |
| Afatinib (BIBW2992) Dimaleate |
| Afatinib (diMaleate) |
| AFATINIB DIMALEATE |
| Afatinib dimaleate (USAN) |
| Afatinib dimaleate [USAN] |
| Afatinib maleate |
| Afatinib maleate (JAN) |
| AK175999 |
| AKOS025401819 |
| AOB87350 |
| BIBW 2992MA2 |
| BIBW2992 MA2 |
| CHEBI:76003 |
| CHEMBL2105712 |
| CS-1329 |
| D09733 |
| Gilotrif (TN) |
| Giotrif |
| Giotrif (TN) |
| HY-10261A |
| KB-333876 |
| MolPort-028-744-902 |
| QC-11139 |
| SC-87788 |
| UNII-V1T5K7RZ0B |
| USNRYVNRPYXCSP-JUGPPOIOSA-N |
| V1T5K7RZ0B |
Paragraph IV (Patent) Challenges for GILOTRIF
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GILOTRIF | TABLET;ORAL | afatinib dimaleate | 201292 | 2017-07-12 |
US Patents and Regulatory Information for GILOTRIF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | 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 |
Expired US Patents for GILOTRIF
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | Start Trial | Start Trial |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | Start Trial | Start Trial |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for GILOTRIF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1152478 | Start Trial |
| Hong Kong | 1060571 | Start Trial |
| Eurasian Patent Organization | 022168 | Start Trial |
| Poland | 2299971 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GILOTRIF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345910 | CR 2014 00006 | Denmark | Start Trial | PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925 |
| 1345910 | 1490011-2 | Sweden | Start Trial | PRODUCT NAME: AFATINIB, TAUTOMERER, STEREOISOMERER OCH SALTER DAERAV, FYSIOLOGISKT GODTAGBARA SALTER MED OORGANISKA ELLER ORGANISKA SYROR ELLER BASER, SAERSKILT ETT MALEATSALT DAERAV, MER FOERETRAEDELSEVIS ETT DIMALEATSALT DAERAV; REG. NO/DATE: EU/1/13/879 20130925 |
| 1345910 | CA 2014 00006 | Denmark | Start Trial | PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925 |
| 1345910 | 6/2014 | Austria | Start Trial | PRODUCT NAME: AFATINIB, DEREN TAUTOMERE, DEREN STEREOISOMERE UND DEREN SALZE, PHYSIOLOGISCH VERTRAEGLICHE SALZE MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, BEVORZUGT DEREN MALEATSALZE, VORZUGSWEISE DEREN DIMALEATSALZE; REGISTRATION NO/DATE: EU/1/13/879 20130925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
