Prescription medicine
Rucaparib camsylate Brand names: Rubraca
Rucaparib camsylate (Rubraca) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the rucaparib camsylate FDA label on DailyMed (effective December 31, 2025, pharmaand GmbH); the NDA 209115 record on Drugs@FDA; every rucaparib camsylate label on DailyMed.
Highlights of the record
FDA label of December 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Forms and strengths
- 200 mg
- 250 mg
- 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 19, 2016 Rubraca, Pharmaand; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 17, 2035 Rubraca tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,779 through July 30, 2026
What is rucaparib camsylate used for?
From the label: indications and usageRUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. ( 1.1 ) Prostate cancer for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. […]
Conditions named in the indications of rucaparib camsylate's FDA labels, with every medicine labeled for each:
From other rucaparib camsylate labelsProstate cancer: BRCA -mutated Metastatic Castration-Resistant Prostate Cancer RUBRACA is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer …
FDA pharmacologic class: Poly(ADP-Ribose) Polymerase Inhibitor.
Source: FDA drug label (Rubraca), pharmaand GmbH, effective December 31, 2025 (SPL set 0295d202-1cfe-7659-e063-6294a90a476e), via openFDA; the full label on DailyMed
What does the patient leaflet for rucaparib camsylate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Rubraca?Rubraca may cause serious side effects including: Bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca. Symptoms of low blood cell counts are common during treatment with Rubraca, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Rubraca: weakness weight loss fever frequent infections blood in urine or stool shortness of breath feeling very tired bruising or bleeding more easily Your healthcare provider will do blood tests to check your blood cell counts: before treatment with Rubraca. every month during treatment with Rubraca. weekly if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve. See "What are possible side effects of Rubraca?" for more information about side effects.
From the patient leaflet: What should I avoid while taking Rubraca?Avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may sunburn more easily during treatment with Rubraca. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.
From the patient leaflet: How should I store Rubraca?Store Rubraca at room temperature between 68°F to 77°F (20°C to 25°C). Keep Rubraca and all medicines out of the reach of children.
Source: FDA drug label (Rubraca), pharmaand GmbH, effective December 31, 2025 (SPL set 0295d202-1cfe-7659-e063-6294a90a476e), via openFDA; the full label on DailyMed
Is there a generic for rucaparib camsylate (Rubraca)?
No generic rucaparib camsylate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Rubraca tablets: the compound patent runs to February 10, 2031, and the last listed entry to August 17, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the rucaparib camsylate label say about other medicines?
The rucaparib camsylate label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring. |
Source: FDA drug label (Rubraca), pharmaand GmbH, effective December 31, 2025 (SPL set 0295d202-1cfe-7659-e063-6294a90a476e), via openFDA; the full label on DailyMed
What do FAERS reports show for rucaparib camsylate?
The FDA Adverse Event Reporting System holds 8,779 reports that list rucaparib camsylate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 505 are coded as a death and 1,469 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as rucaparib camsylate?
8 other medicines are given the same way (oral) and in the same FDA class as rucaparib camsylate or labeled mainly for the same use (prostate cancer), the same class first. Prostate cancer lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Talazoparib | Prostate cancer | none listed | n/a | No current entry |
| Olaparib | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone and niraparib | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone | Prostate cancer | 24 labelers | $0.774 per tablet 250 mg tablet | No current entry |
| Enzalutamide | Prostate cancer | none listed | n/a | No current entry |
| Apalutamide | Prostate cancer | none listed | n/a | No current entry |
| Nilutamide | Prostate cancer | 1 labeler | n/a | A presentation being discontinued |
| Relugolix | Prostate cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as rucaparib camsylate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to rucaparib camsylate
- 8 medicines for the same use
- Other poly(adp-ribose) polymerase inhibitors
- the pharmacologic class, with prices and generics
- Rucaparib camsylate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other