DrugPatentWatch Database Preview
GILOTRIF Drug Profile
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 seventy-six 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.
Summary for GILOTRIF
| International Patents: | 176 |
| 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 | 201292-003 | 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 | 201292-002 | 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 |
|---|---|---|
| Taiwan | I373470 | Start Trial |
| South Africa | 201007805 | Start Trial |
| Australia | 2004281938 | Start Trial |
| China | 1481370 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GILOTRIF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345910 | 2014/009 | Ireland | Start Trial | PRODUCT NAME: AFATINIB, THE TAUTOMERS, THE STEREOISOMERS AND THE SALTS THEREOF, OPTIONALLY IN THE FORM OF PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF WITH INORGANIC OR ORGANIC ACIDS OR BASES, PREFERABLY SALTS WITH MALEIC ACID; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925 |
| 1345910 | C01345910/01 | Switzerland | Start Trial | PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014 |
| 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 | SPC/GB14/015 | United Kingdom | Start Trial | PRODUCT NAME: AFATINIB, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, IN PARTICULAR A SALT WITH MALEIC ACID; REGISTERED: UK EU/1/13/879/001 20130927; UK EU/1/13/879/002 20130927; UK EU/1/13/879/003 20130927; UK EU/1/13/879/004 20130927; UK EU/1/13/879/005 20130927; UK EU/1/13/879/006 20130927; UK EU/1/13/879/007 20130927; UK EU/1/13/879/008 20130927; UK EU/1/13/879/009 20130927; UK EU/1/13/879/010 20130927; UK EU/1/13/879/011 20130927; UK EU/1/13/879/012 20130927 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
