Generic Imbruvica Availability
Imbruvica is a brand name of ibrutinib, approved by the FDA in the following formulation(s):
IMBRUVICA (ibrutinib - capsule;oral)
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Manufacturer: PHARMACYCLICS INC
Approval date: November 13, 2013
Strength(s): 140MG [RLD] -
Manufacturer: PHARMACYCLICS INC
Approval date: December 20, 2017
Strength(s): 70MG [RLD]
IMBRUVICA (ibrutinib - tablet;oral)
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Manufacturer: PHARMACYCLICS INC
Approval date: February 16, 2018
Strength(s): 140MG [RLD], 280MG [RLD], 420MG [RLD], 560MG [RLD]
Has a generic version of Imbruvica been approved?
No. There is currently no therapeutically equivalent version of Imbruvica available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Imbruvica. 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 FAQs.
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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Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,004,746
Issued: June 26, 2018
Assignee(s): Pharmacyclics LLCDisclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
Patent 10,010,507
Issued: July 3, 2018
Assignee(s): Pharmacyclics LLCDescribed herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- March 3, 2036✓
- March 3, 2036
-
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,016,435
Issued: July 10, 2018
Assignee(s): Pharmacyclics LLCDisclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031
-
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,106,548
Issued: October 23, 2018
Assignee(s): Pharmacyclics LLCDescribed herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033✓✓
- June 3, 2033
-
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 10,125,140
Issued: November 13, 2018
Assignee(s): Pharmacyclics LLCDescribed herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033✓✓
- June 3, 2033
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Inhibitors of bruton's tyrosine kinase
Patent 7,514,444
Issued: April 7, 2009
Inventor(s): Honigberg; Lee & Verner; Erik & Pan; Zhengying
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓✓
- December 28, 2026
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Inhibitors of bruton's tyrosine kinase
Patent 8,008,309
Issued: August 30, 2011
Inventor(s): Honigberg; Lee & Verner; Erik & Pan; Zhengying
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓✓
- December 28, 2026
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Inhibitors of Bruton's tyrosine kinase
Patent 8,476,284
Issued: July 2, 2013
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds, including compounds having the Formula (A) where A, R1, R2, R3, and R4 are as defined in the specification, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026
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Inhibitors of Bruton's tyrosine kinase
Patent 8,497,277
Issued: July 30, 2013
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026
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Inhibitors of bruton's tyrosine kinase
Patent 8,563,563
Issued: October 22, 2013
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027
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Inhibitors of bruton'S tyrosine kinase
Patent 8,697,711
Issued: April 15, 2014
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓✓
- December 28, 2026
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Inhibitors of Bruton's tyrosine kinase
Patent 8,703,780
Issued: April 22, 2014
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026
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Inhibitors of Bruton's tyrosine kinase
Patent 8,735,403
Issued: May 27, 2014
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓✓
- December 28, 2026
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Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 8,754,090
Issued: June 17, 2014
Assignee(s): Pharmacyclics, Inc.Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031
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Inhibitors of bruton's tyrosine kinase
Patent 8,754,091
Issued: June 17, 2014
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓
- December 28, 2026
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Inhibitors of Bruton's tyrosine kinase
Patent 8,952,015
Issued: February 10, 2015
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk, such as those having the structure of Formula (A) Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026
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Inhibitors of Bruton's tyrosine kinase
Patent 8,957,079
Issued: February 17, 2015
Assignee(s): Pharmacyclics, Inc.Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk, such as those having the structure: Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓✓
- December 28, 2026
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 8,999,999
Issued: April 7, 2015
Assignee(s): Pharmacyclics, Inc.Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 9,125,889
Issued: September 8, 2015
Assignee(s): Pharmacyclics, Inc.Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Inhibitors of Bruton's tyrosine kinase
Patent 9,181,257
Issued: November 10, 2015
Assignee(s): PHARMACYCLICS LLCDisclosed herein are pyrazolo[3,4-d]pyrimidines that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026✓
- December 28, 2026✓✓
- December 28, 2026
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,296,753
Issued: March 29, 2016
Assignee(s): Pharmacyclics LLCDescribed herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- October 30, 2033✓
- October 30, 2033✓✓
- October 30, 2033
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,540,382
Issued: January 10, 2017
Assignee(s): Pharmacyclics LLCDescribed herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033
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Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 9,655,857
Issued: May 23, 2017
Assignee(s): Pharmacyclics LLCDescribed herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- March 3, 2036✓
- March 3, 2036
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,713,617
Issued: July 25, 2017
Assignee(s): Pharmacyclics LLCDescribed herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033✓
- June 3, 2033
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Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 9,725,455
Issued: August 8, 2017
Assignee(s): Pharmacyclics LLCDescribed herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033✓
- June 3, 2033
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Methods of treating and preventing graft versus host disease
Patent 9,795,604
Issued: October 24, 2017
Assignee(s): Pharmacyclics LLCDescribed herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- October 24, 2034✓
- October 24, 2034
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Patent 9,801,881
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Patent 9,801,883
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Patent 9,814,721
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031
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:
- January 29, 2018 - FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA
- November 13, 2018 - NEW CHEMICAL ENTITY
- March 4, 2019 - PROVIDES FOR THE FRONTLINE INDICATION FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- May 6, 2019 - DOSING RECOMMENDATION ADDED TO THE LABELING FOR IMBRUVICA USE IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LEUKEMIA (SLL)
- May 6, 2019 - REVISED INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA (SLL) WITH 17P DELETION
- May 6, 2019 - REVISED INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA (SLL)
- January 18, 2020 - TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
- August 2, 2020 - TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- November 13, 2020 - TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
- February 12, 2021 - TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
- July 28, 2021 - TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY
- January 29, 2022 - TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
- March 4, 2023 -
- May 6, 2023 -
- January 18, 2024 -
- August 2, 2024 -
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Imbruvica (ibrutinib)
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- Drug class: multikinase 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. |
