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-two patent family members in forty-four 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: | 172 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 31 |
| 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 |
| Prior Art and Litigation Support | Order Prior Art and Litigation support for GILOTRIF |
| DailyMed Link: | GILOTRIF at DailyMed |
Generic Entry Opportunity Date for GILOTRIF
*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.
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 |
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 | 201292-001 | Jul 12, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | |||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 | 201292-001 | Jul 12, 2013 | ➤ Sign Up | ➤ Sign Up |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | ➤ Sign Up | ➤ Sign Up |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for GILOTRIF
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 20 mg, 30 mg and 40 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for GILOTRIF
Supplementary Protection Certificates for GILOTRIF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345910 | 1490011-2 | Sweden | ➤ Sign Up | 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 | PA2014005,C1345910 | Lithuania | ➤ Sign Up | PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925 |
| 1345910 | C01345910/01 | Switzerland | ➤ Sign Up | PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014 |
| 1345910 | 2014C/009 | Belgium | ➤ Sign Up | PRODUCT NAME: AFATINIB ET SES TAUTOMERES, SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES, EN PARTICULIER, AFATINIB SOUS FORME DE SEL DE MALEATE OU DE DIMALEATE; AUTHORISATION NUMBER AND DATE: EU/1/13/879 20130927 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
