Title	Sponsor	Phase
A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer	AbbVie	Phase 1
Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)	AHS Cancer Control Alberta	Phase 2
Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer	Fudan University	Phase 2

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Last updated: September 5, 2026

Veliparib is an unapproved oral PARP1/2 inhibitor developed by AbbVie, formerly Abbott Laboratories. Its strongest clinical evidence came from BRCA-mutated, HER2-negative advanced breast cancer and ovarian cancer, but the program did not progress to FDA approval. As of the public record through June 2024, veliparib has no FDA-approved indication, no Orange Book listing, no commercial revenue, and no established generic-entry event. Its near-term standalone market projection is therefore effectively zero. A redevelopment scenario would require a new sponsor, a narrower biomarker-selected indication, and a differentiated clinical or commercial profile against approved PARP inhibitors.

Veliparib Development Update, Patent Position, FDA Status, and Market Projection

What is the current development status of veliparib?

Veliparib, also known as ABT-888, is an orally administered small-molecule inhibitor of PARP1 and PARP2. AbbVie developed it across breast, ovarian, lung, glioblastoma, and other solid-tumor indications.

The program generated positive phase 3 data in some settings but did not establish a regulatory path to approval. The principal development programs were:

Program	Disease setting	Regimen	Result
BROCADE3	Germline BRCA-mutated, HER2-negative advanced breast cancer	Veliparib plus carboplatin and paclitaxel, followed by veliparib maintenance	Statistically significant progression-free survival benefit
VELIA/GOG-3005	Newly diagnosed advanced ovarian cancer	Veliparib with chemotherapy followed by maintenance	PFS benefit in the overall population and BRCA-mutated subgroup
Lung-cancer studies	Small-cell and non-small-cell lung cancer	Veliparib with chemotherapy or radiotherapy	No commercially sufficient development outcome
Glioblastoma studies	Newly diagnosed or recurrent glioblastoma	Veliparib with temozolomide and radiotherapy	No approval-enabling result

Veliparib remains a clinical-stage asset rather than a marketed pharmaceutical product. AbbVie has not disclosed a commercial launch plan or an active regulatory filing for the molecule in the public sources reviewed.

What did the BROCADE3 trial show?

BROCADE3 was veliparib’s strongest late-stage breast-cancer study. The randomized phase 3 trial enrolled patients with germline BRCA1 or BRCA2 mutations and HER2-negative advanced breast cancer.

The trial reported:

Measure	Veliparib arm	Control arm
Median progression-free survival	14.5 months	12.6 months
Hazard ratio for progression or death	0.71	Reference
Primary endpoint	Met	Not applicable
Overall survival	No statistically significant improvement at final analysis	Reference

Veliparib was administered with carboplatin and paclitaxel, followed by maintenance veliparib. The PFS result supported the biological activity of combining PARP inhibition with platinum chemotherapy. The absence of a confirmed overall-survival advantage weakened the commercial case relative to approved PARP inhibitors that could be prescribed as oral monotherapy or maintenance therapy.

The principal competitive limitation was regimen complexity. Veliparib required combination chemotherapy and introduced additional hematologic toxicity, while olaparib and talazoparib offered established oral PARP-inhibitor approaches for germline BRCA-mutated, HER2-negative advanced breast cancer.

What did the VELIA ovarian-cancer trial show?

VELIA evaluated veliparib during chemotherapy and as maintenance therapy in newly diagnosed advanced ovarian cancer. The trial included an overall population, a BRCA-mutated cohort, and a homologous-recombination-deficient cohort.

The study reported PFS improvements for veliparib-containing treatment, particularly in BRCA-mutated disease. The development concept was similar to a chemotherapy-plus-maintenance strategy rather than simple maintenance monotherapy.

The commercial environment was unfavorable. Ovarian-cancer maintenance treatment already included:

Olaparib for BRCA-mutated disease and selected homologous-recombination-deficient populations.
Niraparib across broader ovarian-cancer maintenance populations.
Rucaparib in selected ovarian-cancer settings, although its regulatory and commercial position later narrowed.

Veliparib’s clinical value was therefore dependent on proving that its addition to chemotherapy created a durable benefit that outweighed toxicity, cost, and treatment complexity. The phase 3 data did not produce a regulatory filing or launch.

What is the FDA regulatory status of veliparib?

Veliparib has no FDA approval as of the public record through June 2024.

FDA-related status	Veliparib position
Approved active ingredient	No
Approved indication	None
New Drug Application approved	No public approval
Orange Book listing	None
FDA-labeled dosage	None
Pediatric exclusivity	None
Orphan-drug exclusivity	None publicly established
Generic approval pathway	Not applicable without an approved reference product

There is no FDA-approved veliparib product against which an abbreviated new drug application could be filed. A future sponsor would likely need to pursue a full 505(b)(1) NDA unless a different regulatory strategy became available.

When does veliparib lose exclusivity?

Veliparib has no commercial exclusivity expiration date because it has no approved product and no marketed reference drug.

Patent term is separate from FDA regulatory exclusivity. Composition-of-matter and use patents may continue to exist after clinical development stops, but they do not create a commercial market without approval. The practical commercial position is:

Exclusivity category	Commercial position
FDA approval exclusivity	None
Orange Book patent exclusivity	None
Reference-listed-drug status	None
Generic launch date	None
Clinical-trial exclusivity	None
Patent-based blocking risk	Potentially relevant to redevelopment, but not an active generic-launch issue

Early Abbott and AbbVie patent families covered PARP-inhibitor compounds, pharmaceutical compositions, therapeutic uses, and manufacturing subject matter. The expiration of individual patent families depends on the specific jurisdiction, priority claims, patent-term adjustment, patent-term extension, and terminal disclaimers. No single “veliparib patent expiration date” determines commercial entry because the drug has never been approved and no Orange Book patent set exists.

What patents protect veliparib?

Veliparib’s historical patent protection was expected to involve several layers:

Composition-of-matter claims covering the active chemical compound or related phthalazinone derivatives.
Pharmaceutical-composition claims covering oral formulations and acceptable salts.
Method-of-use claims covering treatment of cancer, DNA-repair-deficient tumors, BRCA-mutated tumors, and combination treatment with chemotherapy.
Combination-treatment claims covering platinum agents, taxanes, temozolomide, radiotherapy, and maintenance therapy.
Manufacturing and intermediate claims covering synthesis of the active pharmaceutical ingredient.

The strongest historical layer would have been composition-of-matter protection. Use patents would have had lower blocking value because they could be challenged through non-infringement, invalidity, or alternative-label strategies. Combination patents also would have had limited value without a commercially accepted veliparib regimen.

Because veliparib has no approved reference product, there is no public Orange Book patent listing to use as a definitive patent map. A redevelopment sponsor would need a jurisdiction-by-jurisdiction freedom-to-operate review covering U.S., European, Japanese, Chinese, and other national filings.

Are there Paragraph IV challenges to veliparib?

No commercially relevant Paragraph IV litigation has been identified for veliparib.

Paragraph IV litigation generally requires an ANDA applicant challenging patents listed for an FDA-approved reference drug. Veliparib has no approved reference product and no Orange Book listing. As a result:

No established ANDA launch date exists.
No standard 30-month stay has been triggered.
No recognized generic sponsor is preparing an FDA launch.
No active brand-versus-generic patent contest defines the product’s market.

Future Paragraph IV activity would require a veliparib product to receive FDA approval first.

What litigation and settlement agreements affect veliparib?

No major public patent litigation or settlement agreement has shaped veliparib’s commercial position. The principal risk is not generic litigation but development abandonment and asset obsolescence.

Any future transaction would need to evaluate:

Ownership of historical AbbVie patent families.
Continuing prosecution and maintenance obligations.
Inventor and institution rights connected with clinical research.
Trial-data access and regulatory-use rights.
Rights to combination regimens developed with academic groups.
Potential blocking patents held by competitors covering biomarker-selected PARP use.

No public licensing deal has converted veliparib into a marketed product. The asset remains associated with AbbVie’s development history rather than with an active commercial licensee.

How does veliparib compare with approved PARP inhibitors?

Veliparib competes with a mature PARP-inhibitor class that includes olaparib, niraparib, rucaparib, and talazoparib.

Drug	Company origin	Key commercial positioning	Relative veliparib advantage
Olaparib	AstraZeneca/Merck	Breast, ovarian, pancreatic, prostate cancer	Broad approved indications and established maintenance use
Niraparib	Tesaro/GSK	Ovarian-cancer maintenance	Broad maintenance positioning
Rucaparib	Clovis	Ovarian and prostate indications	Earlier class participation, though later commercial restrictions
Talazoparib	Pfizer	HER2-negative advanced breast cancer with germline BRCA mutations	Potent oral monotherapy positioning
Veliparib	Abbott/AbbVie	Investigational combination and maintenance strategies	Potentially lower hematologic burden and combination flexibility

Veliparib’s potential differentiation was not simply PARP inhibition. The program sought to combine PARP inhibition with DNA-damaging chemotherapy while maintaining tolerability. That strategy produced clinical signals but did not overcome the commercial advantages of approved oral monotherapies and maintenance products.

Veliparib also had relatively limited PARP-trapping activity compared with some competitors. That pharmacologic profile may reduce certain toxicities, but it can also reduce antitumor potency in settings where PARP trapping is clinically important.

Does veliparib face biosimilar or generic risk?

Veliparib faces no biosimilar risk because it is a chemically synthesized small molecule, not a biologic. A future product would face conventional generic competition only after approval and patent expiry.

The immediate risk is different: a redevelopment sponsor could spend heavily on clinical trials and encounter competition from lower-cost generic versions of approved PARP inhibitors before veliparib reaches the market. By the late 2020s, generic erosion of some PARP products could reduce pricing across the class and make a late veliparib launch more difficult.

What is the market projection for veliparib?

Veliparib’s current commercial revenue is effectively $0 because the drug is not approved or marketed. A practical projection should separate the base case from a redevelopment case.

Scenario	Assumption	Estimated commercial outcome
Base case	No major sponsor restarts development	$0 annual product sales
Limited redevelopment	Narrow approval in a biomarker-defined combination setting	Approximately $50 million to $150 million peak sales
Successful specialty launch	Approval in BRCA-mutated breast or ovarian cancer with clear differentiation	Approximately $150 million to $300 million peak sales
Broad class recovery	Multiple indications and strong combination data	Above $300 million, low-probability case

These are strategic scenario estimates, not company guidance or consensus forecasts. A commercial launch before 2028 would be difficult without rapid regulatory designation, an existing data package acceptable to FDA, and a partner willing to fund confirmatory studies.

The most credible market opportunity would be a narrow population with one of the following characteristics:

Germline or somatic BRCA1/2 mutation.
Homologous-recombination deficiency.
Resistance or intolerance to approved PARP inhibitors.
A treatment setting where reduced PARP trapping or better marrow tolerability improves chemotherapy combinations.
Central nervous system disease where drug penetration provides a meaningful advantage.

The broad unselected ovarian and breast cancer markets are less attractive because approved competitors already occupy those treatment pathways.

What manufacturing and intellectual-property barriers affect veliparib?

Veliparib is an oral small molecule and does not face the manufacturing complexity associated with monoclonal antibodies or cell therapies. Its active pharmaceutical ingredient is more compatible with conventional small-molecule production, tablet manufacturing, and global supply chains.

The principal barriers are regulatory and intellectual-property related:

Reconstructing a current chemistry, manufacturing, and controls package.
Confirming impurity limits and long-term stability data.
Establishing commercial-scale API supply.
Determining whether historical process patents remain enforceable.
Clearing third-party patents on combination regimens and biomarker-defined uses.
Generating new safety data if the original clinical package is too old or incomplete.
Demonstrating a clinically meaningful advantage over approved PARP inhibitors.

Manufacturing is unlikely to be the primary barrier. The larger issue is whether a sponsor can obtain commercially useful exclusivity for an indication that is clinically and economically differentiated.

What is the likely generic launch scenario?

There is no near-term generic launch scenario because no FDA-approved veliparib reference product exists.

A future sequence would require:

A sponsor acquires or revives the program.
A new or supplemental clinical development plan establishes an approvable indication.
FDA approves an NDA.
Patents and regulatory exclusivities are identified in the Orange Book.
ANDA applicants file after applicable exclusivity and patent constraints.
Paragraph IV litigation or a negotiated settlement determines the first generic-entry date.

The more likely commercial outcome is asset abandonment rather than a conventional brand-to-generic cycle.

Key Takeaways

Veliparib is an unapproved investigational PARP1/2 inhibitor associated with AbbVie.
BROCADE3 produced a PFS benefit in germline BRCA-mutated, HER2-negative advanced breast cancer, but overall survival did not establish a decisive advantage.
VELIA showed activity in advanced ovarian cancer but did not lead to an approved product.
Veliparib has no FDA approval, Orange Book listing, approved exclusivity period, or generic launch date.
No significant Paragraph IV litigation or commercial settlement currently defines the asset.
Biosimilar competition is irrelevant because veliparib is a small molecule.
Current product revenue is effectively zero.
A redevelopment case could support approximately $50 million to $300 million in peak sales, but the probability is low without a new sponsor and a differentiated biomarker-selected indication.
The strongest potential value lies in combination therapy, BRCA- or homologous-recombination-deficiency-selected disease, or a setting where tolerability and tissue penetration provide a clear advantage.

FAQs

Is veliparib approved by the FDA?

No. Veliparib has no FDA-approved indication or marketed reference product.

Who owns veliparib?

Veliparib was developed by Abbott Laboratories and subsequently associated with AbbVie after the Abbott separation. Public development activity has not produced a marketed product or a major external commercial license.

Can generic drug companies launch veliparib?

Not currently. There is no approved reference product and no Orange Book-listed patent set for an ANDA challenge.

Is veliparib more effective than olaparib?

No comparative trial has established superiority. Veliparib showed activity in combination regimens, while olaparib has approved monotherapy and maintenance indications with a substantially stronger commercial position.

What would make veliparib commercially viable?

A sponsor would need a new, differentiated clinical proposition, such as improved tolerability with platinum chemotherapy, a central-nervous-system opportunity, or superior activity in a defined BRCA or homologous-recombination-deficient population.

References

Coleman, R. L., Fleming, G. F., Brady, M. F., Swisher, E. M., Steffensen, K. D., Friedlander, M., Okamoto, A., Moore, K. N., Birrer, M. J., Park, M. S., et al. (2019). Veliparib with first-line chemotherapy and as maintenance therapy in ovarian cancer. New England Journal of Medicine, 381(25), 2403-2415. https://doi.org/10.1056/NEJMoa1909707
Diéras, V., Han, H. S., Kaufman, B., Wildiers, H., Friedlander, M., Ayoub, J. P., Pivot, X., Link, J. S., Bondarenko, I., et al. (2020). Veliparib with carboplatin and paclitaxel in HER2-negative advanced or metastatic breast cancer with germline BRCA mutation: A randomized, double-blind, placebo-controlled phase 3 trial. The Lancet Oncology, 21(10), 1269-1282. https://doi.org/10.1016/S1470-2045(20)30447-8
ClinicalTrials.gov. (n.d.). A study of veliparib with carboplatin and paclitaxel in patients with advanced breast cancer and BRCA mutation: BROCADE3. National Library of Medicine. https://clinicaltrials.gov/study/NCT02163694
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.
AbbVie Inc. (2021). Annual report for the fiscal year ended December 31, 2020. U.S. Securities and Exchange Commission.

US Patents	0
International Patents	0
US Patent Applications	2,743
WIPO Patent Applications	1,020
Japanese Patent Applications	140
Clinical Trial Progress	Phase 3 (2014-08-05)
Vendors	56

Investigational Drug Information for Veliparib

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