TYKERB Drug Patent Profile
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When do Tykerb patents expire, and when can generic versions of Tykerb launch?
Tykerb is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twenty-eight patent family members in twenty-six countries.
The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Tykerb
A generic version of TYKERB was approved as lapatinib ditosylate by NATCO PHARMA LTD on September 29th, 2020.
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Questions you can ask:
- What is the 5 year forecast for TYKERB?
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Summary for TYKERB
International Patents: | 28 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 96 |
Patent Applications: | 3,310 |
Drug Prices: | Drug price information for TYKERB |
What excipients (inactive ingredients) are in TYKERB? | TYKERB excipients list |
DailyMed Link: | TYKERB at DailyMed |
Recent Clinical Trials for TYKERB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Aslan Pharmaceuticals | Phase 2 |
Scariot Foundation | N/A |
GlaxoSmithKline | N/A |
Pharmacology for TYKERB
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for TYKERB
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TYKERB | Tablets | lapatinib ditosylate | 250 mg | 022059 | 1 | 2011-03-14 |
US Patents and Regulatory Information for TYKERB
TYKERB is protected by one US patents.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | |
>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 TYKERB
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Subscribe | ⤷ Subscribe |
Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TYKERB
When does loss-of-exclusivity occur for TYKERB?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4252
Patent: COMPOSICION FARMACEUTICA ORAL QUE CONTIENE SALES DE DITOSILATO DE 4-QUINAZOLINAMINA
Estimated Expiration: ⤷ Subscribe
Australia
Patent: 06236423
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0609962
Patent: composição farmacêutica oral, e, método para tratar um distúrbio em um mamìfero
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 06207
Patent: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
China
Patent: 1203211
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0161429
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 18179
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 71347
Estimated Expiration: ⤷ Subscribe
Eurasian Patent Organization
Patent: 0702253
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 71347
Patent: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 30982
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 02302
Estimated Expiration: ⤷ Subscribe
Patent: 08536931
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 71347
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 07013089
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Subscribe
Morocco
Patent: 404
Patent: PREPARATION PHARMACEUTIQUE
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 2223
Patent: Pharmaceutical composition comprising lapatinib or N-{3-chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methanesulphonyl)ethyl]amino}methyl)-2-furyl]4-quinazolinamine
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 075111
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 061430
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE COMPUESTOS DE 4-QUINAZOLINAMINAS
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 71347
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 71347
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 71347
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 0708705
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1356748
Estimated Expiration: ⤷ Subscribe
Patent: 080005557
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 01503
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 0716204
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Subscribe
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering TYKERB around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 49779 | BICIKLIČNA HETEROAROMATIČNA JEDINJENJA KAO INHIBITORI PROTEIN TIROZIN KINAZE (BYCICLIC HETEROAROMATIC COMPOUNDS AS PROTEIN TYROSINE KINASE INHIBITORS) | ⤷ Subscribe |
Iceland | 2276 | ⤷ Subscribe | |
Poland | 341595 | ⤷ Subscribe | |
Croatia | P20060387 | ⤷ Subscribe | |
Denmark | 1047694 | ⤷ Subscribe | |
South Korea | 20030014414 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TYKERB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1047694 | SZ 37/2008 | Austria | ⤷ Subscribe | PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON |
1047694 | SPC026/2008 | Ireland | ⤷ Subscribe | SPC026/2008: 20091118, EXPIRES: 20230609 |
1047694 | CA 2008 00040 | Denmark | ⤷ Subscribe | PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT |
1047694 | SPC/GB08/044 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: LAPATINIB OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/07/440/001 20080610; UK EU/1/07/440/002 20080610 |
1047694 | 300360 | Netherlands | ⤷ Subscribe | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT |
1047694 | 91475 | Luxembourg | ⤷ Subscribe | 91475, EXPIRES: 20230610 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
TYKERB Market Analysis and Financial Projection Experimental
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