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Generic Lynparza Availability

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

LYNPARZA (olaparib - capsule;oral)

  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: December 19, 2014
    Strength(s): 50MG [RLD]

LYNPARZA (olaparib - tablet;oral)

  • Manufacturer: ASTRAZENECA PHARMS
    Approval date: August 17, 2017
    Strength(s): 100MG [RLD], 150MG [RLD]

Has a generic version of Lynparza been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lynparza. 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.

  • Phthalazinone derivatives
    Patent 7,151,102
    Issued: December 19, 2006
    Inventor(s): Martin; Niall Morrison Barr & Smith; Graeme Cameron Murray & White; Charles Richard & Newton; Roger Frank & Douglas; Diane Gillian & Eversley; Penny Jane & Vile; Julia
    Assignee(s): Kudos Pharmaceuticals Limited Maybridge PLC

    A method of treatment of a disease of the human or animal body mediated by PARP comprising administering to such a subject a therapeutically effective amount of a compound of formula: or an isomer, salt, solvate, chemically protected form, and prodrug thereof, wherein: A and B together represent an optionally substituted, fused aromatic ring; RC is represented by —L—RL, where L is of formula: —(CH2)n1-Qn2-(CH2)n3— wherein n1, n2 and n3 are each selected from 0, 1, 2 and 3, the sum of n1, n2 and n3 is 1, 2 or 3 and Q is selected from O, S, NH, C(═O) or —CR1R2—, where R1 and R2 are independently selected from hydrogen, halogen or optionally substituted C1-7 alkyl, or may together with the carbon atom to which they are attached form a C3-7 cyclic alkyl group, which may be saturated (a C3-7 cycloalkyl group) or unsaturated (a C3-7 cycloalkenyl group), or one of R1 and R2 may be attached to an atom in RL to form an unsaturated C3-7 cycloalkenyl group which comprises the carbon atoms to which R1 and R2 are attached in Q, —(CH2)n3— (if present) and part of RL; and RL is optionally substituted C5-20 aryl; and RN is selected from hydrogen, optionally substituted C1-7 alkyl, C3-20 heterocyclyl, and C5-20 aryl, hydroxy, ether, nitro, amino, amido, thiol, thioether, sulfoxide and sulfone.

    Patent expiration dates:

    • April 29, 2022
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      Drug substance
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  • Phthalazinone derivatives
    Patent 7,449,464
    Issued: November 11, 2008
    Inventor(s): Martin; Niall Morrison Barr & Smith; Graeme Cameron & Jackson; Stephen Philip & Loh; Vincent Junior M & Cockcroft; Xiao-Ling Fan & Matthews; Ian Timothy Williams & Menear; Keith Allan & Kerrigan; Frank & Ashworth; Alan
    Assignee(s): Kudos Pharmaceuticals Limited Maybridge Limited

    Compounds of the formula (I): wherein A and B together represent an optionally substituted, fused aromatic ring; X can be NRX or CRXRY; if X=NRX then n is 1 or 2 and if X=CRXRY then n is 1; RX is selected from the group consisting of H, optionally substituted C1-20 alkyl, C5-20 aryl, C3-20 heterocyclyl, amido, thioamido, ester, acyl, and sulfonyl groups; RY is selected from H, hydroxy, amino; or RX and RY may together form a spiro-C3-7 cycloalkyl or heterocyclyl group; RC1 and RC2 are both hydrogen, or when X is CRXRY, RC1, RC2, RX and RY, together with the carbon atoms to which they are attached, may form an optionally substituted fused aromatic ring; and R1 is selected from H and halo.

    Patent expiration dates:

    • October 11, 2024
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      Drug substance
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      Drug product
  • Phthalazinone derivatives
    Patent 7,981,889
    Issued: July 19, 2011
    Inventor(s): Barr Martin; Niall Morrison & Smith; Graeme Cameron & Jackson; Stephen Philip & Loh; Vincent Junior M & Cockcroft; Xiao-Ling Fan & Williams Matthews; Ian Timothy & Menear; Keith Allan & Kerrigan; Frank & Ashworth; Alan
    Assignee(s): Kudos Pharmaceuticals Limited Maybridge Limited

    Compounds of the formula (I): wherein A and B together represent an optionally substituted, fused aromatic ring; X can be NRX or CRXRY; if X═NRX then n is 1 or 2 and if X═CRXRY then n is 1; RX is selected from the group consisting of H, optionally substituted C1-20 alkyl, C5-20 aryl, C3-20 heterocyclyl, amido, thioamido, ester, acyl, and sulfonyl groups; RY is selected from H, hydroxy, amino; or RX and RY may together form a spiro-C3-7 cycloalkyl or heterocyclyl group; RC1 and RC2 are both hydrogen, or when X is CRXRY, RC1, RC2, RX and RY, together with the carbon atoms to which they are attached, may form an optionally substituted fused aromatic ring; and R1 is selected from H and halo.

    Patent expiration dates:

    • October 11, 2024
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  • DNA damage repair inhibitors for treatment of cancer
    Patent 8,143,241
    Issued: March 27, 2012
    Inventor(s): Ashworth; Alan & Jackson; Stephen & Martin; Niall & Smith; Graeme & O'Connor; Mark
    Assignee(s): Kudos Pharmaceuticals Limited The Institute of Cancer Research

    The present invention relates to the recognition that inhibition of the base excision repair pathway is selectively lethal in cells which are deficient in HR dependent DNA DSB repair. Methods and means relating to the treatment of cancers which are deficient in HR dependent DNA DSB repair using inhibitors which target base excision repair components, such as PARP, is provided herein.

    Patent expiration dates:

    • August 12, 2027
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      Patent use: TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
    • August 12, 2027
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      Patent use: TREATMENT OF PATIENTS WITH HORMONE RECEPTOR (HR)-NEGATIVE BREAST CANCER WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM, HER2-NEGATIVE METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
    • August 12, 2027
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      Patent use: MAINTENANCE TREATMENT OF BRCA-MUTATED RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • August 12, 2027
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      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • August 12, 2027
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      Patent use: TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY BASED ON AN FDA-APPROVED COMPANION DIAGNOSTIC FOR LYNPARZA
    • August 12, 2027
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      Patent use: TREATMENT OF PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE BREAST CANCER WHO SHOULD HAVE BEEN TREATED WITH PRIOR ENDOCRINE THERAPY OR BE CONSIDERED INAPPROPRIATE FOR ENDOCRINE THERAPY
  • Phthalazinone derivative
    Patent 8,247,416
    Issued: August 21, 2012
    Inventor(s): Menear; Keith Allan & Ottridge; Anthony Peter & Londesbrough; Derek John & Hallett; Michael Raymond & Mulholland; Keith Raymond & Pittam; John David & Laffan; David Dermot Patrick & Ashworth; Ian Woodward & Jones; Martin Francis & Cherryman; Janette Helen
    Assignee(s): Kudos Pharmaceuticals Limited

    4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one as crystalline Form A.

    Patent expiration dates:

    • September 24, 2028
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      Drug substance
  • Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
    Patent 8,475,842
    Issued: July 2, 2013
    Assignee(s): Astrazeneca AB

    The present invention relates to a pharmaceutical formulation comprising the drug 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one in a solid dispersion with a matrix polymer that exhibits low hygroscopicity and high softening temperature, such as copovidone. The invention also relates to a daily pharmaceutical dose of the drug provided by such a formulation. In addition, the invention relates to the use of a matrix polymer that exhibits low hygroscopicity and high softening temperature in solid dispersion with 4-[3-(4-cyclopropanecarbonyl-piperazine-1 -carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one for increasing the bioavailability of the drug.

    Patent expiration dates:

    • December 31, 2029
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      Drug product
  • Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
    Patent 8,859,562
    Issued: October 14, 2014
    Assignee(s): The University of Sheffield

    The present invention relates to the use of an agent that inhibits the activity of an enzyme that mediates repair of a DNA strand break in the manufacture of a medicament for the treatment of diseases caused by a defect in a gene that mediates homologous recombination.

    Patent expiration dates:

    • August 4, 2031
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      Patent use: TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
    • August 4, 2031
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH HORMONE RECEPTOR (HR)-NEGATIVE BREAST CANCER WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM, HER2-NEGATIVE METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING
    • August 4, 2031
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE BREAST CANCER WHO SHOULD HAVE BEEN TREATED WITH PRIOR ENDOCRINE THERAPY OR BE CONSIDERED INAPPROPRIATE FOR ENDOCRINE THERAPY
    • August 4, 2031
      ✓ 
      Patent use: TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY BASED ON AN FDA-APPROVED COMPANION DIAGNOSTIC FOR LYNPARZA
    • August 4, 2031
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      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
  • Phthalazinone derivatives
    Patent 8,912,187
    Issued: December 16, 2014
    Assignee(s): Kudos Pharmaceuticals Limited

    Compounds of the formula (I): wherein A and B together represent an optionally substituted, fused aromatic ring; X can be NRX or CRXRY; if X═NRX then n is 1 or 2 and if X═CRXRY then n is 1; RX is selected from the group consisting of H, optionally substituted C1-20 alkyl, C5-20 aryl, C3-20 heterocyclyl, amido, thioamido, ester, acyl, and sulfonyl groups; RY is selected from H, hydroxy, amino; or RX and RY may together form a spiro-C3-7 cycloalkyl or heterocyclyl group; RC1 and RC2 are both hydrogen, or when X is CRXRY, RC1, RC2, RX and RY, together with the carbon atoms to which they are attached, may form an optionally substituted fused aromatic ring; and R1 is selected from H and halo.

    Patent expiration dates:

    • March 12, 2024
      ✓ 
      Patent use: TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
    • March 12, 2024
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • March 12, 2024
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE BREAST CANCER WHO SHOULD HAVE BEEN TREATED WITH PRIOR ENDOCRINE THERAPY OR BE CONSIDERED INAPPROPRIATE FOR ENDOCRINE THERAPY
    • March 12, 2024
      ✓ 
      Patent use: TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY BASED ON AN FDA-APPROVED COMPANION DIAGNOSTIC FOR LYNPARZA
    • March 12, 2024
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH HORMONE RECEPTOR (HR)-NEGATIVE BREAST CANCER WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM, HER2-NEGATIVE METASTATIC BREAST CANCER, WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN NEOADJUVANT, ADJUVANT, OR METASTATIC SETTING

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, 2019 - NEW CHEMICAL ENTITY
    • August 17, 2020 - NEW PRODUCT
    • January 12, 2021 - TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE METASTATIC BREAST CANCER WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT OR METASTATIC SETTING
    • December 19, 2021 - USE OF AS MONOTHERAPY FOR PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA MUTATED (AS DETECTED BY AN FDA-APPROVED TEST) ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
    • August 17, 2024 -
    • August 17, 2024 -

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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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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