Generic Tykerb Availability

Tykerb is a brand name of lapatinib, approved by the FDA in the following formulation(s):

TYKERB (lapatinib ditosylate - tablet;oral)

  • Manufacturer: SMITHKLINE BEECHAM
    Approval date: March 13, 2007
    Strength(s): EQ 250MG BASE [RLD]

Has a generic version of Tykerb been approved?

No. There is currently no therapeutically equivalent version of Tykerb available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tykerb. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Fused heterocyclic compounds as protein tyrosine kinase inhibitors
    Patent 6,391,874
    Issued: May 21, 2002
    Inventor(s): George Stuart; Cockerill & Malcolm Clive; Carter & Stephen Barry; Guntrip & Kathryn Jane; Smith
    Assignee(s): SmithKline Beecham Corporation
    Substituted heteroaromatic compounds of formula (I) and in particular substituted quinolines and quinazolines, are protein tyrosine kinase inhibitors. The compounds are described as are methods for their preparation, pharmaceutical compositions including such compounds and their use in medicine, for example in the treatment of cancer and psoriasis, or a salt or solvate thereof; wherein X is N or CH; Y is a group W(CH2), (CH2)W, or W, in which W is O, S(O)m wherein m is 0, 1 or 2, or NRa wherein Ra is hydrogen or a C1-8 alkyl group; R1 represents a phenyl group or a 5- or 6-membered heterocyclic ring containing 1 to 4 heteroatoms selected from N, O or S(O)m, wherein m is as defined above, with the provisos that the ring does not contain two adjacent O or S(O)m atoms and that where the ring contains only N as heteroatom(s) the ring is C-linked to the quinazoline or quinoline ring, R1 being optionally substituted by one or more R3;groups; P=0 to 3; U, R2, R3 are as defined in the application.
    Patent expiration dates:
    • July 11, 2017
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      Patent use: TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB
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    • July 11, 2017
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      Patent use: TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2 RECEPTOR
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  • Heterocyclic compounds
    Patent 6,713,485
    Issued: March 30, 2004
    Inventor(s): Malcolm Clive; Carter & George Stuart; Cockerill & Stephen Barry; Guntrip & Karen Elizabeth; Lackey & Kathryn Jane; Smith
    Assignee(s): SmithKline Beecham Corporation
    The present invention relates to substituted heteroaromatic compounds, methods for their preparation, pharmaceutical compositions containing them and their use in medicine. Specifically, the invention relates to quinazoline derivatives useful in treating disorders mediated by protein tyrosine kinase activity, in particular erbB-2 and/or EGFR activity.
    Patent expiration dates:
    • September 29, 2020
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      Patent use: TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB
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    • September 29, 2020
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  • Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
    Patent 6,727,256
    Issued: April 27, 2004
    Inventor(s): Malcolm Clive; Carter & George Stuart; Cockerill & Stephen Barry; Guntrip & Karen Elizabeth; Lackey & Kathryn Jane; Smith
    Assignee(s): SmithKline Beecham Corporation
    Substituted heteroaromatic compounds of formula (I), wherein X is N or CH; Y is CR1 and V is N; or Y is N and V is CR1; or Y is CR1 and V is CR2; or Y is CR2 and V is CR1; R1 represents a group CH3SO2CH2CH2NHCH2—Ar—, wherein Ar is selected from phenyl, furan, thiophene, pyrrole and thiazole, each of which may optionally be substituted by one or two halo, C1-4alkyl or C1-4alkoxy groups; R2 is selected from the group comprising hydrogen, halo, hydroxy, C1-4alkyl, C1-4alkoxy, C1-4alkylamino and di[C1-4alkyl]amino; U represents a phenyl, pyridyl, 3H-imidazolyl, indolyl, isoindolyl, indolinyl, isoindolinyl, 1H-indazolyl, 2,3-dihydro-1H-indazolyl, 1H-benzimidazolyl, 2,3-dihydro-1H-benzimidazolyl or 1H-benzotriazolyl group, substituted by an R3 group and optionally substituted by at least one independently selected R4 group; R3 is selected from a group comprising benzyl, halo-, dihalo- and trihalobenzyl, benzoyl, pyridylmethyl, pyridylmethoxy, phenoxy, benzyloxy, halo-, dihalo- and trihalobenzyloxy and benzenesulphonyl, or R3 represents trihalomethylbenzyl or trihalomethylbenzyloxy; or R3 represents a group of formula (a) wherein each R5 is independently selected from halogen, C1-4alkyl, C1-4alkoxy; and n is 0 to 3; each R4 is independently hydroxy, halogen, C1-4alkyl, C2-4alkenyl, C2-4alkynyl, C1-4alkoxy, amino, C1-4alkylamino, di[C1-4alkyl]amino, C1-4alkylthio, C1-4alkylsulphinyl, C1-4alkylsulphonyl, C1-4alkylcarbonyl, carboxy, carbamoyl, C1-4alkoxycarbonyl, C1-4alkanoylamino, N-(C1-4alkyl)carbamoyl, N,N-di(C1-4alkyl)carbamoyl, cyano, nitro and trifluoromethyl; and salts and solvates thereof, are disclosed, as are methods for their preparation, pharmaceutical compositions containing them and their use in medicine.
    Patent expiration dates:
    • January 8, 2019
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      Patent use: TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB
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    • January 8, 2019
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  • Heterocyclic compounds
    Patent 6,828,320
    Issued: December 7, 2004
    Inventor(s): George Stuart; Cockerill & Malcolm Clive; Carter & Stephen Barry; Guntrip & Kathryn Jane; Smith
    Assignee(s): SmithKline Beecham Corporation
    Substituted heteroaromatic compounds, and in particular substituted quinolines and quinazolines, are protein tyrosine kinase inhibitors. The compounds are described as are methods for their preparation, pharmaceutical compositions including such compounds and their use in medicine, for example in the treatment of cancer and psoriasis.
    Patent expiration dates:
    • July 11, 2017
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      Patent use: TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A TAXANE AND TRASTUZUMAB
    • July 11, 2017
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      Patent use: TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2 RECEPTOR
  • Quinazoline ditosylate salt compounds
    Patent 7,157,466
    Issued: January 2, 2007
    Inventor(s): McClure; Michael Scott & Osterhout; Martin Howard & Roschangar; Frank & Sacchetti; Mark Joseph
    Assignee(s): SmithKline Beecham (Cork) Limited
    Ditosylate salts of 4-quinazolineamines are described as well as methods of using the same in the treatment of disorde4rs characterized by aberrant erbB family PTK activity.
    Patent expiration dates:
    • November 19, 2021
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  • Bicyclic heteroaromatic compounds as protein tyrosine kinase inhibitors
    Patent 8,513,262
    Issued: August 20, 2013
    Assignee(s): GlaxoSmithKline LLC
    A process for the preparation of a compound of formula (I) comprising the steps: (a) reacting a compound of formula (II) wherein L and L′ are suitable leaving groups, with a compound of formula (III) UNH2  (III) to prepare a compound of formula (IV) and subsequently (b) substituting the group R1 by replacement of the leaving group L′.
    Patent expiration dates:
    • January 8, 2019
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Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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