Lynparza is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 15 US drug patents filed from 2015 to 2024. Out of these, 9 drug patents are active and 6 have expired. Lynparza's patents have been open to challenges since 19 December, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 25, 2041. Details of Lynparza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8247416 | Phthalazinone derivative |
Sep, 2028
(3 years from now) | Active |
| US7449464 | Phthalazinone derivatives |
Oct, 2024
(a month ago) |
Expired
|
| US7981889 | Phthalazinone derivatives |
Oct, 2024
(a month ago) |
Expired
|
| US7151102 | Phthalazinone derivatives |
Apr, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11970530 | Methods of treating homologous recombination deficient cancer |
Oct, 2041
(16 years from now) | Active |
| US8859562 | Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer |
Aug, 2031
(6 years from now) | Active |
| US8475842 | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Dec, 2029
(5 years from now) | Active |
| US11975001 | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Oct, 2029
(4 years from now) | Active |
| US12048695 | Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one |
Oct, 2029
(4 years from now) | Active |
| US11633396 | Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one |
Oct, 2029
(4 years from now) | Active |
| US8071579 | DNA damage repair inhibitors for the treatment of cancer |
Aug, 2027
(2 years from now) | Active |
| US8143241 | DNA damage repair inhibitors for treatment of cancer |
Aug, 2027
(2 years from now) | Active |
| US9169235 | Phthalazinone derivatives |
Mar, 2024
(8 months ago) |
Expired
|
| US8912187 | Phthalazinone derivatives |
Mar, 2024
(8 months ago) |
Expired
|
| US9566276 | Phthalazinone derivatives |
Mar, 2024
(8 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Lynparza's patents.
Latest Legal Activities on Lynparza's Patents
Given below is the list of recent legal activities going on the following patents of Lynparza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Letter from FDA or Dept of Agriculture re PTE application | 26 Mar, 2024 | US7449464 |
| Mail-Petition Decision - Dismissed Critical | 08 Feb, 2024 | US7449464 |
| Petition Decision - Dismissed Critical | 07 Feb, 2024 | US7449464 |
| Notice of Final Determination -Eligible | 07 Feb, 2024 | US7449464 |
| Patent Term Extension Certificate Critical | 07 Feb, 2024 | US7449464 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 06 Feb, 2024 | US7449464 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Feb, 2024 | US8247416 |
| Terminal Disclaimer Filed Critical | 18 Jan, 2024 | US7449464 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Sep, 2023 | US8143241 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 May, 2023 | US8071579 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Lynparza and ongoing litigations to help you estimate the early arrival of Lynparza generic.
Lynparza's Litigations
Lynparza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 11, 2011, against patent number US8859562. The petitioner , challenged the validity of this patent, with Thomas Helleday as the respondent. Click below to track the latest information on how companies are challenging Lynparza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8859562 | October, 2011 |
Decision
(25 Mar, 2014) | Thomas Helleday | |
FDA has granted some exclusivities to Lynparza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lynparza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lynparza.
Exclusivity Information
Lynparza holds 16 exclusivities out of which 11 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Lynparza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2019 |
| New Product(NP) | Aug 17, 2020 |
| New Indication(I-762) | Jan 12, 2021 |
| New Indication(I-776) | Dec 19, 2021 |
| Orphan Drug Exclusivity(ODE) | Dec 19, 2021 |
| Orphan Drug Exclusivity(ODE-83) | Dec 19, 2021 |
| New Indication(I-818) | Dec 27, 2022 |
| New Indication(I-831) | May 08, 2023 |
| New Indication(I-832) | May 19, 2023 |
| Orphan Drug Exclusivity(ODE-180) | Aug 17, 2024 |
| Orphan Drug Exclusivity(ODE-181) | Aug 17, 2024 |
| New Indication(I-885) | Mar 11, 2025 |
| Orphan Drug Exclusivity(ODE-226) | Dec 19, 2025 |
| New Indication(I-914) | May 31, 2026 |
| Orphan Drug Exclusivity(ODE-283) | Dec 27, 2026 |
| Orphan Drug Exclusivity(ODE-306) | May 08, 2027 |
Several oppositions have been filed on Lynparza's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Lynparza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Lynparza patents.
Lynparza's Oppositions Filed in EPO
Lynparza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 13, 2012, by Adams, Harvey Vaughan John. This opposition was filed on patent number EP04743564A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP09740728A | Apr, 2017 | Teva Pharmaceutical Industries Ltd | Patent maintained as amended |
| EP04798705A | May, 2012 | STRAWMAN LIMITED | Opposition procedure closed |
| EP04798705A | May, 2012 | Adams, Harvey Vaughan John | Opposition procedure closed |
| EP04743564A | Apr, 2012 | STRAWMAN LIMITED | Patent maintained as amended |
| EP04743564A | Apr, 2012 | Adams, Harvey Vaughan John | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Lynparza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Lynparza's family patents as well as insights into ongoing legal events on those patents.
Lynparza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lynparza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 25, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lynparza Generics:
There are no approved generic versions for Lynparza as of now.
How can I launch a generic of Lynparza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lynparza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lynparza's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Lynparza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 150 mg | 01 Nov, 2022 | 1 | 04 Aug, 2031 |
About Lynparza
Lynparza is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating various types of cancers, including breast, ovarian, pancreatic, and metastatic prostate cancer, in patients with specific gene mutations undergoing specific chemotherapy regimens. Lynparza uses Olaparib as an active ingredient. Lynparza was launched by Astrazeneca in 2017.
Approval Date:
Lynparza was approved by FDA for market use on 17 August, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Lynparza is 17 August, 2017, its NCE-1 date is estimated to be 19 December, 2018.
Active Ingredient:
Lynparza uses Olaparib as the active ingredient. Check out other Drugs and Companies using Olaparib ingredient
Treatment:
Lynparza is used for treating various types of cancers, including breast, ovarian, pancreatic, and metastatic prostate cancer, in patients with specific gene mutations undergoing specific chemotherapy regimens.
Dosage:
Lynparza is available in the following dosage forms - tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 50MG | CAPSULE | Discontinued | ORAL |