Rubraca Patent Expiration

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

(10 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

(2 months ago)

Expired
US7351701 Therapeutic compounds
Jul, 2024

(2 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.

Given below is the list of recent legal activities going on the following patents of Rubraca.

Activity Date Patent Number
Patent litigations
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) 05 Mar, 2021 US10130636
Correspondence Address Change 04 Mar, 2021 US9987285
Correspondence Address Change 04 Mar, 2021 US10130636
Change in Power of Attorney (May Include Associate POA) 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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Rubraca has patent protection in a total of 43 countries. It's US patent count contributes only to 17.2% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Rubraca.

Family Patents

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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
Akeega used for treating metastatic castration-resistant prostate cancer associated with a deleterious BRCA mutation.





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