TYKERB Drug Patent Profile
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Which patents cover Tykerb, and what generic alternatives are available?
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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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: | 3,411 |
| 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 |
| GlaxoSmithKline | N/A |
| University of Alabama at Birmingham | 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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 TYKERB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | TYKERB | lapatinib ditosylate | TABLET;ORAL | 022059-001 | Mar 13, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Australia
Patent: 06236423
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0609962
Patent: composição farmacêutica oral, e, método para tratar um distúrbio em um mamìfero
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 06207
Patent: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1203211
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0161429
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 18179
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 71347
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0702253
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 71347
Patent: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30982
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 02302
Estimated Expiration: ⤷ Sign Up
Patent: 08536931
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 71347
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07013089
Patent: COMPOSICION FARMACEUTICA. (PHARMACEUTICAL COMPOSITION.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 404
Patent: PREPARATION PHARMACEUTIQUE
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Norway
Patent: 075111
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 061430
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE COMPUESTOS DE 4-QUINAZOLINAMINAS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 71347
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 71347
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 71347
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0708705
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1356748
Estimated Expiration: ⤷ Sign Up
Patent: 080005557
Patent: PHARMACEUTICAL COMPOSITION
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 01503
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0716204
Patent: Pharmaceutical composition
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| European Patent Office | 1294715 | COMPOSES DITOSYLATES DE QUINAZOLINE (QUINAZOLINE DITOSYLATE SALT COMPOUNDS) | ⤷ Sign Up |
| South Korea | 20080005557 | PHARMACEUTICAL COMPOSITION | ⤷ Sign Up |
| Eurasian Patent Organization | 200000637 | ⤷ Sign Up | |
| Portugal | 1460072 | ⤷ Sign Up | |
| Norway | 316176 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON |
| 1047694 | 300360 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), OVERDRACHT |
| 1047694 | CA 2008 00040 | Denmark | ⤷ Sign Up | PRODUCT NAME: LAPATINIB ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER LAPATINIBDITOSYLATMONOHYDRAT |
| 1047694 | SPC026/2008 | Ireland | ⤷ Sign Up | SPC026/2008: 20091118, EXPIRES: 20230609 |
| 1047694 | 37/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: LAPATINIB ALS FREIE BASE ODER EIN SALZ ODER EIN SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/07/440/001-002 20080610 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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