Details for Patent: 8,545,884
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Which drugs does patent 8,545,884 protect, and when does it expire?
Patent 8,545,884 protects GILOTRIF and is included in one NDA.
Protection for GILOTRIF has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has thirty-nine patent family members in thirty-five countries.
Summary for Patent: 8,545,884
| Title: | Solid pharmaceutical formulations comprising BIBW 2992 |
| Abstract: | The present invention relates to a pharmaceutical dosage form containing the active substance BIBW 2992 as the dimaleate salt, providing an immediate release profile of the active substance, further, the invention relates to compacted intermediates comprising BIBW 2992 dimaleate salt (BIBW 2992 MA.sub.2) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA.sub.2, intermediate blends prepared from said compacted intermediate as well as solid oral formulations providing an immediate release profile of the active substance, made from said compacted intermediate or from said intermediate blends ready for use/ingestion, e.g. capsule and tablet formulations such as uncoated or film-coated tablets prepared by direct-compression, and methods for their production. |
| Inventor(s): | Messerschmid; Roman (Biberach, DE), Friedl; Thomas (Ochsenhausen, DE) |
| Assignee: | Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE) |
| Application Number: | 12/995,715 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,545,884 |
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Patent Claim Types: see list of patent claims | Composition; Compound; Formulation; Dosage form; Use; |
Drugs Protected by US Patent 8,545,884
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 8,545,884
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| 08157800 | Jun 6, 2008 | |
| 09160297 | May 14, 2009 | |
| PCT Information | |||
| PCT Filed | June 05, 2009 | PCT Application Number: | PCT/EP2009/056944 |
| PCT Publication Date: | December 10, 2009 | PCT Publication Number: | WO2009/147238 |
International Family Members for US Patent 8,545,884
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 072062 | ⤷ Try a Trial | |||
| Australia | 2009254574 | ⤷ Try a Trial | |||
| Brazil | PI0913379 | ⤷ Try a Trial | |||
| Canada | 2726472 | ⤷ Try a Trial | |||
| Chile | 2010001275 | ⤷ Try a Trial | |||
| China | 102056589 | ⤷ Try a Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
