Generic Bosulif Availability
Last updated on Apr 10, 2025.
Bosulif is a brand name of bosutinib, approved by the FDA in the following formulation(s):
BOSULIF (bosutinib monohydrate - capsule;oral)
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Manufacturer: PF PRISM CV
Approval date: September 26, 2023
Strength(s): EQ 50MG BASE [RLD], EQ 100MG BASE [RLD]
BOSULIF (bosutinib monohydrate - tablet;oral)
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Manufacturer: PF PRISM CV
Approval date: September 4, 2012
Strength(s): EQ 100MG BASE [RLD], EQ 500MG BASE [RLD] -
Manufacturer: PF PRISM CV
Approval date: October 27, 2017
Strength(s): EQ 400MG BASE [RLD]
Is there a generic version of Bosulif available?
No. There is currently no therapeutically equivalent version of Bosulif available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bosulif. 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: Generic Drug FAQ.
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.
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Treatment of imatinib resistant leukemia
Patent 11,103,497
Issued: August 31, 2021
Inventor(s): Hewes Becker
Assignee(s): Wyeth LLCThe present invention provides 4-anilino-3-quinolinecarbonitriles compounds useful for treating a subject having an BcrAbl positive leukemia that is resistant to imatinib.
Patent expiration dates:
- February 28, 2034✓
- February 28, 2034✓
- February 28, 2034
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Treatment of imatinib resistant leukemia
Patent 11103497*PE
Issued: August 31, 2021
Inventor(s): Hewes Becker
Assignee(s): Wyeth LLCThe present invention provides 4-anilino-3-quinolinecarbonitriles compounds useful for treating a subject having an BcrAbl positive leukemia that is resistant to imatinib.
Patent expiration dates:
- August 28, 2034
- August 28, 2034
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4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent 7,417,148
Issued: August 26, 2008
Inventor(s): Boschelli; Frank et al.
Assignee(s): Wyeth (Madison, NJ)Compounds of the formula: ##STR00001## wherein: n is an integer from 1-3; X is N, CH, provided that when X is N, n is 2 or 3; R is alkyl of 1 to 3 carbon atoms; R.sup.1 is 2,4-diCl, 5-OMe; 2,4-diCl; 3,4,5-tri-OMe; 2-Cl, 5-OMe; 2-Me, 5-OMe; 2,4-di-Me; 2,4-diMe-5-OMe, 2,4-diCl, 5-OEt; R.sup.2 is alkyl of 1 to 2 carbon atoms, and pharmaceutically acceptable salts thereof.
Patent expiration dates:
- December 11, 2025✓
- December 11, 2025✓
- December 11, 2025✓
- December 11, 2025
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4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent 7417148*PED
Issued: August 26, 2008
Inventor(s): Boschelli; Frank et al.
Assignee(s): Wyeth (Madison, NJ)Compounds of the formula: ##STR00001## wherein: n is an integer from 1-3; X is N, CH, provided that when X is N, n is 2 or 3; R is alkyl of 1 to 3 carbon atoms; R.sup.1 is 2,4-diCl, 5-OMe; 2,4-diCl; 3,4,5-tri-OMe; 2-Cl, 5-OMe; 2-Me, 5-OMe; 2,4-di-Me; 2,4-diMe-5-OMe, 2,4-diCl, 5-OEt; R.sup.2 is alkyl of 1 to 2 carbon atoms, and pharmaceutically acceptable salts thereof.
Patent expiration dates:
- June 11, 2026✓
- June 11, 2026
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Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same
Patent 7,767,678
Issued: August 3, 2010
Inventor(s): Tesconi; Marc Sadler et al.
Assignee(s): Wyeth LLC (Madison, NJ)This invention is directed to a crystalline 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile monohydrate having an x-ray diffraction pattern wherein 2.theta. angles (.degree.) of significant peaks are at about: 9.19, 11.48, 14.32, 19.16, 19.45, 20.46, 21.29, 22.33, 23.96, 24.95, 25.29, 25.84, 26.55, 27.61, and 29.51, and a transition temperature of about 109.degree. C. to about 115.degree. C.
Patent expiration dates:
- November 23, 2026✓✓
- November 23, 2026
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Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same
Patent 7767678*PED
Issued: August 3, 2010
Inventor(s): Tesconi; Marc Sadler et al.
Assignee(s): Wyeth LLC (Madison, NJ)This invention is directed to a crystalline 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile monohydrate having an x-ray diffraction pattern wherein 2.theta. angles (.degree.) of significant peaks are at about: 9.19, 11.48, 14.32, 19.16, 19.45, 20.46, 21.29, 22.33, 23.96, 24.95, 25.29, 25.84, 26.55, 27.61, and 29.51, and a transition temperature of about 109.degree. C. to about 115.degree. C.
Patent expiration dates:
- May 23, 2027✓
- May 23, 2027
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4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent 7,919,625
Issued: April 5, 2011
Inventor(s): Boschelli; Frank et al.
Assignee(s): Wyeth LLC (Madison, NJ)Compounds of the formula: ##STR00001## wherein: n is an integer from 1-3; X is N, CH, provided that when X is N, n is 2 or 3; R is alkyl of 1 to 3 carbon atoms; R.sup.1 is 2,4-diCl, 5-OMe; 2,4-diCl; 3,4,5-tri-OMe; 2-Cl, 5-OMe; 2-Me, 5-OMe; 2,4-di-Me; 2,4-diMe-5-OMe, 2,4-diCl, 5-OEt; R.sup.2 is alkyl of 1 to 2 carbon atoms, and pharmaceutically acceptable salts thereof.
Patent expiration dates:
- December 11, 2025✓
- December 11, 2025
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4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Patent 7919625*PED
Issued: April 5, 2011
Inventor(s): Boschelli; Frank et al.
Assignee(s): Wyeth LLC (Madison, NJ)Compounds of the formula: ##STR00001## wherein: n is an integer from 1-3; X is N, CH, provided that when X is N, n is 2 or 3; R is alkyl of 1 to 3 carbon atoms; R.sup.1 is 2,4-diCl, 5-OMe; 2,4-diCl; 3,4,5-tri-OMe; 2-Cl, 5-OMe; 2-Me, 5-OMe; 2,4-di-Me; 2,4-diMe-5-OMe, 2,4-diCl, 5-OEt; R.sup.2 is alkyl of 1 to 2 carbon atoms, and pharmaceutically acceptable salts thereof.
Patent expiration dates:
- June 11, 2026✓
- June 11, 2026
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- December 19, 2024 - TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
- June 19, 2025 - PEDIATRIC EXCLUSIVITY
- September 26, 2026 - NEW PRODUCT
- September 26, 2026 - FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY
- March 26, 2027 - PEDIATRIC EXCLUSIVITY
- September 26, 2030 - TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML), NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY
- March 26, 2031 - PEDIATRIC EXCLUSIVITY
More about Bosulif (bosutinib)
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- Drug class: BCR-ABL tyrosine kinase inhibitors
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A 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 Exclusivity | Exclusivity 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. |
| RLD | A 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. |
Further information
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