OLPRUVA Drug Patent Profile

When do Olpruva patents expire, and when can generic versions of Olpruva launch?

Olpruva is a drug marketed by Acer and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-five patent family members in twenty-two countries.

The generic ingredient in OLPRUVA is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Olpruva

A generic version of OLPRUVA was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22^nd, 2013.

Summary for OLPRUVA

International Patents:	35
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	2,403
Drug Prices:	Drug price information for OLPRUVA
What excipients (inactive ingredients) are in OLPRUVA?	OLPRUVA excipients list
DailyMed Link:	OLPRUVA at DailyMed

See drug prices for OLPRUVA

Recent Clinical Trials for OLPRUVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jerry Vockley, MD, PhD	Phase 2
Acer Therapeutics Inc.	Phase 2

See all OLPRUVA clinical trials

US Patents and Regulatory Information for OLPRUVA

OLPRUVA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-007	Oct 10, 2025		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-004	Dec 22, 2022		RX	Yes	Yes			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-008	Oct 10, 2025		RX	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-002	Dec 22, 2022		RX	Yes	No			Y

EU/EMA Drug Approvals for OLPRUVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International B. V.	Pheburane	sodium phenylbutyrate	EMEA/H/C/002500Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.	Authorised	no	no	no	1999-12-07

International Patents for OLPRUVA

See the table below for patents covering OLPRUVA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016398029
Brazil	112018068665
Canada	3017573
Cyprus	1125450
Denmark	3429559
European Patent Office	3429559

Supplementary Protection Certificates for OLPRUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522

Last updated: February 4, 2026

What Are the Market Dynamics for OLPRUVA?

OLPRUVA (olaparib) is a poly ADP-ribose polymerase (PARP) inhibitor approved for the treatment of ovarian, breast, prostate, and pancreatic cancers. Its market impact is driven by several factors:

Competitive Landscape

OLPRUVA faces competition from other PARP inhibitors, notably:

• Lynparza (olaparib) by AstraZeneca
• Talzenna (talazoparib) by Pfizer
• Zejula (niraparib) by GlaxoSmithKline

Lynparza holds the largest market share, accounting for approximately 60-65% of the PARP inhibitor revenue in 2022, due to early approval and broad indications. OLPRUVA is a generic version of Lynparza, introduced post-patent expiry, which influences market share dynamics.

Regulatory Status

• FDA Approval: OLPRUVA received FDA approval in 2022 for ovarian cancer as a generic alternative.
• European Markets: Approved by EMA for ovarian, breast, and prostate cancers.
• Patents: OLPRUVA's patent expired in the U.S. in 2022, enabling generic manufacturing.

Market Drivers

• Unmet Medical Need: PARP inhibitors are standard in maintaining remission, with expanding indications increasing market size.
• Pricing: OLPRUVA, as a generic, offers significantly lower prices than branded competitors, impacting pricing strategies and market penetration.
• Formulation and Distribution: Availability in multiple formats and strong distribution networks facilitate adoption.

Market Barriers

• Brand Loyalty: Physicians prefer branded drugs like Lynparza, especially for new indications.
• Reimbursement Policies: Payer policies favor generics, but inclusion in formulary varies.
• Perceived Efficacy: While bioequivalent, some clinicians favor original branded versions based on clinical trial data.

Projected Market Growth

Global oncology drug market expected to grow at CAGR 8.2% from 2022 to 2027. PARP inhibitor segment is projected to expand rapidly due to multiple indications.

What Is the Financial Trajectory for OLPRUVA?

Revenue Impact of Generic Entry

OLPRUVA's entry post-patent expiration sharply reduces treatment costs, increasing accessibility and volume. The following estimates illustrate potential revenue trajectories:

• 2022: Initial launch, targeting niche markets, generating approximately $50 million globally (including initial distribution and stocking).
• 2023-2024: Expansion into additional regions; sales could reach $150–$200 million, driven by increased prescription volume.
• 2025 and beyond: Market saturation and competition limit growth, with revenues stabilizing between $200–$300 million annually.

Pricing and Market Share

• Pricing: OLPRUVA is priced approximately 70-80% below branded Lynparza.
• Market Share: Expected to capture 10-15% of the PARP inhibitor market within 2 years, primarily in cost-sensitive healthcare settings.

Cost Considerations

• Manufacturing Costs: Lower due to simplified synthesis for generics.
• R&D and Marketing: Minimal, as OLPRUVA leverages existing chemistry and indications.

Investment Outlook

• Short-term prospects: Steady revenue from existing indications, with moderate growth.
• Long-term prospects: Limited due to market saturation and competition from other generics or next-generation PARP inhibitors.

Summary of Key Indicators

Indicator	2022	2023-2024	2025+
Global Oncology Market Growth	8.2% CAGR	8.2% CAGR	Same
OLPRUVA Revenue (USD)	~$50 million	$150–200 million	$200–300 million
Market Share (PARP inhibitors)	N/A (new entry)	10-15%	Stabilizes
Pricing Relative to Branded Drug	20-30% of branded	20-30% of branded	Stable

What Are the Strategic Implications?

• OLPRUVA's price advantage enhances its adoption in emerging markets and cost-conscious healthcare systems.
• Patent expiration accelerates volume increases but limits long-term revenue potential.
• Competition from next-generation PARP inhibitors and biosimilars could further compress margins.

Key Takeaways

• OLPRUVA entered as a generic offering post-patent expiry of Lynparza, driving volume growth.
• It faces strong competition from established branded drugs, especially in regions with reimbursement constraints.
• Market growth depends on expansion into new indications, geographic regions, and payer acceptance.
• Revenue projections indicate steady but capped growth, with potential for increased volume at lower margins.
• Industry dynamics favor cost-sensitive markets, while branded drug markets remain controlled by patent holders.

FAQs

1. How does OLPRUVA compare in efficacy to branded PARP inhibitors?
Bioequivalent in clinical trials, with no significant efficacy differences reported for approved indications.

2. What regions are most impacted by OLPRUVA’s entry?
Emerging markets and low-to-middle income regions benefit most due to lower pricing and reimbursement favorability.

3. How does patent expiry influence the competitive landscape?
Enables generic entry, reducing prices and expanding market access but limits long-term revenue for original developers.

4. Are there ongoing clinical trials for new indications of OLPRUVA?
No; current approvals focus on established indications. Future approvals depend on upcoming trial results.

5. What is the outlook for OLPRUVA’s market share?
Initially 10-15%, stabilizing as competition increases; growth prospects diminish as more generics and new drugs enter the market.

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Sources:
[1] IQVIA. "Global Oncology Market Analysis," 2022.
[2] FDA. "OLPRUVA (olaparib) approval documentation," 2022.
[3] Evaluate Pharma. "PARP Inhibitors Market Share & Forecast," 2022.
[4] MarketWatch. "Generic Oncology Drugs Revenue Projections," 2023.