Lynparza Generic: When Will Generic Olaparib Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Lynparza Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2029 to 2030 A wide window Why then?
- Has the FDA approved a generic? Not yet 4 companies hold tentative approvals Why not yet?
- When does the brand’s protection end? October 2041 The last of 12 listed patents Why sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Dr. Brian Staiger Explains
PharmD, BCPS · Clinical pharmacistGeneric olaparib is expected to be available between 2029 and 2030, first for Lynparza tablets. None is for sale yet. Each product has its own month below.
Why 2029 to 2030?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Lynparza’s protection runs to October 2041, how can a generic come sooner?
The 2 patents that run past the expected month, to October 2041 (8,859,562 and 11,970,530), cover a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, the companies are expected to settle on a date. Generic companies have been challenging Lynparza’s patents with the FDA since November 2022. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. 4 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Sandoz Inc (May 2025), Cipla Limited (June 2025), Zydus Pharms USA Inc (November 2025) and 1 more. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Lynparza as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
- tablets2029 to 2030Probable · settlement expected
- capsulesa date that is not known yetNot rated · not yet clear
Our month is only an estimate based on available information, so we never name a day.
Lynparza by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Strong 5 companies have filed, 1 first in line
- Brand sales
- $1.7B a yearBlockbuster
- FDA approved 2014 December 2014 FDA Orange Book
- Patents listed 12 last runs to October 2041 FDA Orange Book
- Medicare Part D spent $819.7M in 2025, for 8,925 people CMS Part D Spending by Drug
- Medicaid prescriptions 6,754 in the last four reported quarters, $101.2M CMS Medicaid drug utilization, to Q1 2026
Lynparza’s Road to a Generic
Lynparza has had the market to itself since the FDA approved it in December 2014 (Astrazeneca Pharmaceuticals LP). Its FDA protection (orphan drug) runs to May 2027. Its 12 listed patents run to October 2041. Generic companies have challenged its patents with the FDA since November 2022.
The first generic of Lynparza is expected between 2029 and 2030.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before October 2041
The last listed patent runs to October 2041, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Lynparza Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lynparza’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,071,579 | A way of using it (U-3631, U-2716, U-2483, U-2482, U-3695, U-2820, U-2824, U-2833, U-2823, U-2832, U-2480, U-2821, U-2819, U-2822, U-3333) | August 2027 | Active |
| 8,143,241 | A way of using it (U-1634, U-2482, U-2480, U-2716, U-2483, U-3631, U-2824, U-2823, U-2821, U-2819, U-2820, U-2822, U-3695, U-2832, U-2833, U-3333) | August 2027 | Active |
| 7,449,464 | The active ingredient; the product’s formulation | September 2027 | Active |
| 8,247,416 | The active ingredient | September 2028 | Active |
| 11,633,396 | The product’s formulation | October 2029 | Active |
| 11,975,001 | The product’s formulation | October 2029 | Active |
| 12,048,695 | The product’s formulation | October 2029 | Active |
| 12,144,810 | The product’s formulation | October 2029 | Active |
| 12,178,816 | The product’s formulation | October 2029 | Active |
| 8,475,842 | The product’s formulation | December 2029 | Active |
| 8,859,562 | A way of using it (U-1634, U-2101, U-2482, U-2483, U-2716, U-2480, U-3631, U-2103, U-2833, U-2822, U-2821, U-2823, U-2824, U-2820, U-2819, U-3695, U-2832, U-3333) | August 2031 | Active |
| 11,970,530 | A way of using it (U-3929, U-3930, U-3931) | October 2041 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-914 | Three years of protection for a newly approved use (indication). | May 2026 | Ended |
| Orphan drug ODE-283 | Seven years of protection for a use in a rare disease. | December 2026 | Active |
| Orphan drug ODE-306 | Seven years of protection for a use in a rare disease. | May 2027 | Active |
Source: FDA Orange Book, application 206162, 208558. Patent numbers open the patent on Google Patents.
Patent Challenges to Lynparza
The first patent challenge to Lynparza reached the FDA in November 2022, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Lynparza’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 100 mg and 150 mg | November 2022 | 1 company | No decision yet | Not yet | Not yet | August 2031 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Olaparib
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
5 companies have applied to the FDA to make generic olaparib.
The FDA has tentatively approved 4 companies’ generics, listed below. A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Lynparza’s patents with the FDA since November 2022: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic olaparib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic olaparib for sale with the FDA.
| Company | Tentatively approved |
|---|---|
| Sandoz Inc | May 2025 |
| Cipla Limited | June 2025 |
| Zydus Pharms USA Inc | November 2025 |
| Natco Pharma Limited | Not given |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Lynparza Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Lynparza, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Lynparza
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Lynparza, before manufacturer rebates.
- $210.1M
- January to March 2026, the latest CMS has posted
For 5,582 people, about $14,940 per prescription fill - $819.7M
- 2025, the whole year
For 8,925 people, about $14,741 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $210,099,592 | 5,582 | $14,939.88 |
| 2025 | $819,736,719 | 8,925 | $14,741.08 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Lynparza only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain cancers (such as breast, ovarian, fallopian tube, pancreatic, peritoneal cancer, prostate). Olaparib works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
6,754 prescriptions in the four quarters to Q1 2026, $101.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 1,591 | $24,248,794 |
| Q4 2025 | 1,602 | $23,955,797 |
| Q3 2025 | 1,873 | $27,843,537 |
| Q2 2025 | 1,688 | $25,111,139 |
| Q1 2025 | 1,690 | $25,669,701 |
Source: CMS Medicaid State Drug Utilization Data, over Lynparza’s own package codes.
Lynparza Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | August 2017 | Prescription reference product |
| 150MG | Tablet | Oral | August 2017 | Prescription reference product |
| 50MG | Capsule | Oral | December 2014 | Discontinued reference product |
Source: FDA Orange Book, Astrazeneca Pharmaceuticals LP. Listed for sale today by AstraZeneca Pharmaceuticals LP (FDA NDC Directory).
Lynparza NDC Codes and Packages
Each Lynparza package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00310-0569-12 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 120 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0569-60 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0668-12 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 120 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0668-12 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 120 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0668-60 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0668-60 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0668-95 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0668-95 | OLAPARIB 100 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
Show the other 8 Lynparza packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 00310-0578-12 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 120 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0578-60 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0679-12 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 120 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0679-12 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 120 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0679-60 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0679-60 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0679-95 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
| 00310-0679-95 | OLAPARIB 150 mg/1 tablet, film coated | bottle of 60 tablets | AstraZeneca Pharmaceuticals LP |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lynparza’s own FDA approval (NDA 206162, NDA 208558) are listed, never a generic. Some codes belong to companies that repackage Lynparza: it is the same medicine in a different package.
What a Generic Lynparza Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Lynparza as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Lynparza”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Lynparza
Is there a generic for Lynparza right now?
No. As of October 9, 2026 no generic olaparib is listed for sale in the FDA NDC Directory.
When will Lynparza go generic?
2029 to 2030 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to October 2041, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic olaparib be the same as Lynparza?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Lynparza?
Not yet. The FDA Orange Book lists no approved generic version of Lynparza.
When does the Lynparza patent expire?
The FDA Orange Book lists 12 patents for Lynparza; the last runs to October 2041. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (2029 to 2030) weighs all of that.
Has anyone challenged the Lynparza patents?
Yes. The first patent challenge to Lynparza reached the FDA in November 2022, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected 2029 to 2030 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- JentaduetoLinagliptin and Metformin HydrochlorideJuly to December 2026
- SpinrazaNusinersen2033 to 2034
- VyleesiBremelanotide AcetateNovember 2033
- ElyxybCelecoxibMay 2036
- OnivydeIrinotecanOctober 2036
- ArtesunateArtesunateFebruary 2044
About Lynparza
- Generic name olaparib
- How it is taken By mouth
- Company Astrazeneca Pharmaceuticals LP
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since November 2022 (FDA)
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lynparza
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.