Rubraca is a drug owned by Pharmaand Gmbh. It is protected by 12 US drug patents filed from 2016 to 2019. Out of these, 9 drug patents are active and 3 have expired. Rubraca's patents have been open to challenges since 19 December, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 17, 2035. Details of Rubraca'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. | |||
| US9045487 | Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one |
Feb, 2031
(6 years from now) | Active |
| US8754072 | Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one |
Feb, 2031
(6 years from now) | Active |
| US6495541 | Tricyclic inhibitors of poly(ADP-ribose) polymerases |
Nov, 2023
(11 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10130636 | High dosage strength tablets of rucaparib |
Aug, 2035
(10 years from now) | Active |
| US9987285 | High dosage strength tablets of rucaparib |
Aug, 2035
(10 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 |
| US9861638 | Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one |
Feb, 2031
(6 years from now) | Active |
| US10278974 | Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one |
Feb, 2031
(6 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 |
| US7531530 | Therapeutic compounds |
Jul, 2024
(3 months ago) |
Expired
|
| US7351701 | Therapeutic compounds |
Jul, 2024
(3 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 Rubraca's patents.
Latest Legal Activities on Rubraca's Patents
Given below is the list of recent legal activities going on the following patents of Rubraca.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2022 | US9045487 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Oct, 2022 | US10278974 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 May, 2022 | US10130636 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754072 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Nov, 2021 | US9987285 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jun, 2021 | US9861638 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Mar, 2021 | US10130636 |
| Correspondence Address Change Critical | 04 Mar, 2021 | US9987285 |
| Correspondence Address Change Critical | 04 Mar, 2021 | US10130636 |
| Change in Power of Attorney (May Include Associate POA) Critical | 04 Mar, 2021 | US9987285 |
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 Rubraca and ongoing litigations to help you estimate the early arrival of Rubraca generic.
Rubraca's Litigations
Rubraca 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 Rubraca's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8859562 | October, 2011 |
Decision
(25 Mar, 2014) | Thomas Helleday | |
FDA has granted some exclusivities to Rubraca. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rubraca, 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 Rubraca.
Exclusivity Information
Rubraca holds 6 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Rubraca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-772) | Apr 06, 2021 |
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2021 |
| New Indication(I-830) | May 15, 2023 |
| Orphan Drug Exclusivity(ODE) | Dec 19, 2023 |
| Orphan Drug Exclusivity(ODE-126) | Dec 19, 2023 |
| Orphan Drug Exclusivity(ODE-168) | Apr 06, 2025 |
Several oppositions have been filed on Rubraca'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 Rubraca's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rubraca patents.
Rubraca's Oppositions Filed in EPO
Rubraca has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 13, 2012, by Strawman Limited. This opposition was filed on patent number EP04743564A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16183844A | Apr, 2020 | Generics [UK] Ltd | Granted and Under Opposition |
| EP11708094A | Jun, 2017 | Hexal AG / Sandoz International GmbH | Granted and Under Opposition |
| EP11708094A | Jun, 2017 | Hamm&Wittkopp Patentanwälte PartmbB | Granted and Under Opposition |
| EP04798705A | May, 2012 | Adams, Harvey Vaughan John | Opposition procedure closed |
| EP04798705A | May, 2012 | STRAWMAN LIMITED | Opposition procedure closed |
| EP04743564A | Apr, 2012 | Adams, Harvey Vaughan John | Patent maintained as amended |
| EP04743564A | Apr, 2012 | STRAWMAN LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Rubraca 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 Rubraca's family patents as well as insights into ongoing legal events on those patents.
Rubraca's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rubraca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 17, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rubraca Generics:
There are no approved generic versions for Rubraca as of now.
Alternative Brands for Rubraca
Rubraca which is used for treating cancers associated with deleterious BRCA mutations, such as epithelial ovarian, fallopian tube, primary peritoneal cancer, and metastatic castration-resistant prostate cancer., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Janssen Biotech |
| |||
About Rubraca
Rubraca is a drug owned by Pharmaand Gmbh. It is used for treating cancers associated with deleterious BRCA mutations, such as epithelial ovarian, fallopian tube, primary peritoneal cancer, and metastatic castration-resistant prostate cancer. Rubraca uses Rucaparib Camsylate as an active ingredient. Rubraca was launched by Pharmaand in 2016.
Approval Date:
Rubraca was approved by FDA for market use on 19 December, 2016.
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 Rubraca is 19 December, 2016, its NCE-1 date is estimated to be 19 December, 2020.
Active Ingredient:
Rubraca uses Rucaparib Camsylate as the active ingredient. Check out other Drugs and Companies using Rucaparib Camsylate ingredient
Treatment:
Rubraca is used for treating cancers associated with deleterious BRCA mutations, such as epithelial ovarian, fallopian tube, primary peritoneal cancer, and metastatic castration-resistant prostate cancer.
Dosage:
Rubraca is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE | TABLET | Prescription | ORAL |
| EQ 200MG BASE | TABLET | Prescription | ORAL |
| EQ 250MG BASE | TABLET | Prescription | ORAL |