Generic Lynparza Availability
Last updated on Apr 10, 2025.
Lynparza is a brand name of olaparib, approved by the FDA in the following formulation(s):
LYNPARZA (olaparib - capsule;oral)
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Manufacturer: ASTRAZENECA
Approval date: December 19, 2014
Strength(s): 50MG (discontinued) [RLD]
LYNPARZA (olaparib - tablet;oral)
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Manufacturer: ASTRAZENECA
Approval date: August 17, 2017
Strength(s): 100MG [RLD], 150MG [RLD]
Is there a generic version of Lynparza available?
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 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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Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one
Patent 11,633,396
Issued: April 25, 2023
Inventor(s): Bechtold; Michael Karl et al.
Assignee(s): Kudos Pharmaceuticals Limited (Cambridge, GB)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:
- October 7, 2029✓
- October 7, 2029
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Methods of treating homologous recombination deficient cancer
Patent 11,970,530
Issued: April 30, 2024
Inventor(s): Milenkova-Ilieva; Tsveta Petrova et al.
Assignee(s): ASTRAZENECA AB (Sodertalje, SE)This disclosure relates to methods of treating homologous recombination (HR) deficient cancers, such as ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, and/or pancreatic cancer. This disclosure further relates to preventing, controlling or reducing hypertension and/or proteinuria in a subject receiving a therapeutically effective amount of bevacizumab therapy.
Patent expiration dates:
- October 25, 2041✓
- October 25, 2041✓
- October 25, 2041✓
- October 25, 2041
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Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Patent 11,975,001
Issued: May 7, 2024
Inventor(s): Bechtold; Michael Karl et al.
Assignee(s): KUDOS PHARMACEUTICALS LIMITED (Cambridge, GB)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:
- October 7, 2029✓
- October 7, 2029
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Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Patent 12,048,695
Issued: July 30, 2024
Inventor(s): Bechtold; Michael Karl et al.
Assignee(s): KUDOS PHARMACEUTICALS LIMITED (Cambridge, GB)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:
- October 7, 2029✓
- October 7, 2029
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Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Patent 12,144,810
Issued: November 19, 2024
Inventor(s): Bechtold; Michael Karl et al.
Assignee(s): KUDOS PHARMACEUTICALS LIMITED (Cambridge, GB)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:
- October 7, 2029✓
- October 7, 2029
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Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Patent 12,178,816
Issued: December 31, 2024
Inventor(s): Bechtold; Michael Karl et al.
Assignee(s): KUDOS PHARMACEUTICALS LIMITED (Cambridge, GB)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:
- October 7, 2029✓
- October 7, 2029
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Phthalazinone derivatives
Patent 7,449,464
Issued: November 11, 2008
Inventor(s): Martin; Niall Morrison Barr et al.
Assignee(s): Kudos Pharmaceuticals Limited (Cambridge, GB); Maybridge Limited (Cornwall, GB)Compounds of the formula (I): ##STR00001## wherein A and B together represent an optionally substituted, fused aromatic ring; X can be NR.sup.X or CR.sup.XR.sup.Y; if X=NR.sup.X then n is 1 or 2 and if X=CR.sup.XR.sup.Y then n is 1; R.sup.X is selected from the group consisting of H, optionally substituted C.sub.1-20 alkyl, C.sub.5-20 aryl, C.sub.3-20 heterocyclyl, amido, thioamido, ester, acyl, and sulfonyl groups; R.sup.Y is selected from H, hydroxy, amino; or R.sup.X and R.sup.Y may together form a spiro-C.sub.3-7 cycloalkyl or heterocyclyl group; R.sup.C1 and R.sup.C2 are both hydrogen, or when X is CR.sup.XR.sup.Y, R.sup.C1, R.sup.C2, R.sup.X and R.sup.Y, together with the carbon atoms to which they are attached, may form an optionally substituted fused aromatic ring; and R.sup.1 is selected from H and halo.
Patent expiration dates:
- September 8, 2027✓✓
- September 8, 2027
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DNA damage repair inhibitors for the treatment of cancer
Patent 8,071,579
Issued: December 6, 2011
Inventor(s): Ashworth; Alan et al.
Assignee(s): The Institute of Cancer Research: Royal Cancer Hospital (London, GB); Kudos Pharmaceuticals Limited (Cambridge, GB)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✓
- August 12, 2027✓
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- August 12, 2027
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DNA damage repair inhibitors for treatment of cancer
Patent 8,143,241
Issued: March 27, 2012
Inventor(s): Ashworth; Alan et al.
Assignee(s): Kudos Pharmaceuticals Limited (Cambridge, GB); The Institute of Cancer Research (London, GB)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✓
- August 12, 2027✓
- August 12, 2027✓
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- August 12, 2027✓
- August 12, 2027
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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 Limited4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one as crystalline Form A.
Patent expiration dates:
- September 24, 2028✓
- September 24, 2028
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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
Inventor(s): Bechtold Michael Karl & Packhaeuser Claudia Bettina & Fastnacht Katja Maren & Liepold Bernd Harald & Steitz Benedikt & Cahill Julie Kay & Lennon Kieran James
Assignee(s): Astrazeneca ABThe 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✓
- December 31, 2029
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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
Inventor(s): Helleday Thomas
Assignee(s): The University of SheffieldThe 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✓
- August 4, 2031✓
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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:
- March 11, 2025 - FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY
- December 19, 2025 - MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
- May 31, 2026 - IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
- December 27, 2026 - MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
- May 8, 2027 - W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY
More about Lynparza (olaparib)
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- Drug class: PARP inhibitors
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Glossary
Term | Definition |
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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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