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 twenty-five patent family members in twenty 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. Six 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:	25
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	1
Patent Applications:	1,712
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
Acer Therapeutics Inc.	Phase 2
Jerry Vockley, MD, PhD	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	214860-001	Dec 22, 2022		RX	Yes	No	11,202,767
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	Yes	11,154,521		Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No	11,202,767
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-002	Dec 22, 2022		RX	Yes	No	11,202,767
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-004	Dec 22, 2022		RX	Yes	No	11,433,041		Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-003	Dec 22, 2022		RX	Yes	No	11,154,521		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/002500 Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219 Ammonaps 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
Israel	261777	הרכבים טעימים הכוללים נתרן פנילביוטירייט ושימושים עבורם (Palatable compositions including sodium phenylbutyrate and uses thereof)
South Korea	20190008840	소듐 페닐부티레이트를 포함하는 맛우수한 조성물 및 그의 용도
Hungary	E059630
Portugal	3429559
Japan	2019509345	フェニル酪酸ナトリウムを含む口当たりの良い組成物及びその使用
World Intellectual Property Organization (WIPO)	2017160345

Supplementary Protection Certificates for OLPRUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2465580	SPC/GB21/030	United Kingdom		PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119

OLPRUVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OLPRUVA

Introduction to OLPRUVA

OLPRUVA, developed by Zevra Therapeutics, is a treatment for urea cycle disorders (UCDs), a group of rare genetic disorders that can lead to the accumulation of toxic levels of ammonia in the blood. Here, we will delve into the market dynamics and financial trajectory of OLPRUVA, highlighting its launch, challenges, and future prospects.

Launch and Commercial Availability

The full commercial launch of OLPRUVA was initiated at the end of January 2024. This launch marked a significant milestone for Zevra Therapeutics as it began to make the drug available to patients with UCDs[1][4].

Market Access and Reimbursement

As of May 1, 2024, OLPRUVA has achieved market access for nearly 75% of covered lives, indicating a substantial improvement in reimbursement coverage. This is a crucial factor for the drug's success, as reimbursement issues were initially a significant challenge[1][4].

Patient Enrollment and Specialist Engagement

During the first quarter of 2024, Zevra Therapeutics engaged with over 90% of the specialists at the 40 centers of excellence that treat UCD patients. The company reported four new patient enrollments, defined as prescriptions for patients eligible for either benefits investigation or the Company’s Quick Start program[1].

Challenges Faced by OLPRUVA

Despite the progress made, the launch of OLPRUVA has underperformed expectations due to several factors:

• Low Patient Awareness: There has been a lack of awareness among patients and healthcare providers about the availability and benefits of OLPRUVA, which has impacted its adoption rate[3].
• Reimbursement Issues: Although reimbursement coverage has improved, initial challenges in this area have slowed down the drug's market penetration[3].

Financial Performance and Revenue Projections

In the fourth quarter of 2023, Zevra Therapeutics recognized some initial sales of OLPRUVA, contributing to the company's net revenue. However, the revenue from OLPRUVA is still in its early stages and has not yet met the company's full expectations.

• Q4 2023 Revenue: The company reported net revenue of $13.2 million for Q4 2023, which included initial sales of OLPRUVA, royalties under the AZSTARYS license agreement, and reimbursements from the French Early Access Program (EAP) for arimoclomol[2][4].
• Peak Sales Projections: Analysts project peak sales of OLPRUVA to be approximately $100 million by 2030, suggesting there is potential for improvement in the product's market performance over time[3].

Cash Runway and Financial Outlook

Zevra Therapeutics has a solid financial position that supports the ongoing commercial activities of OLPRUVA. Here are some key financial highlights:

• Cash Position: As of the latest reports, Zevra Therapeutics has a cash position that extends its operating cash runway into 2026 or even 2027, depending on the source. This provides stability and flexibility to support the company's strategic priorities[2][3][4].
• Revenue Streams: The company's cash runway forecast includes revenue from OLPRUVA sales, ongoing reimbursements from the French EAP for arimoclomol, and other sources such as royalties and potential monetization of the Priority Review Voucher (PRV)[1][2][4].

Strategic Focus and Future Prospects

Zevra Therapeutics is focused on several strategic objectives to enhance the market performance of OLPRUVA and its overall pipeline:

• Commercial Infrastructure: The company has accelerated the build-out of a focused and effective customer-facing team with decades of experience in rare diseases. This team is crucial for the successful launch and commercialization of OLPRUVA and other pipeline products[4].
• Pipeline Development: The success of OLPRUVA is closely tied to the advancement of other pipeline products, such as arimoclomol and KP1077. Positive outcomes in these programs could diversify Zevra's revenue streams and establish the company as a leader in multiple rare disease markets[1][3][4].

SWOT Analysis for OLPRUVA

Strengths

• Established Commercial Infrastructure: Zevra has a well-established commercial infrastructure for rare disease products, which supports the launch and ongoing sales of OLPRUVA[3].
• Increasing Reimbursement Coverage: The improvement in reimbursement coverage is a significant strength, as it enhances patient access to the drug[1][4].

Weaknesses

• Underperformance: The launch of OLPRUVA has underperformed expectations due to low patient awareness and initial reimbursement issues[3].
• Limited Discovery Capabilities: Zevra has halted its in-house prodrug platform discovery activities, which could limit future innovation and pipeline growth[3].

Opportunities

• Expansion and Partnerships: There are opportunities for expanding OLPRUVA into new markets and potential partnerships for its development and commercialization[3].
• Monetization of PRV: The potential monetization of the Priority Review Voucher could strengthen Zevra's financial position and support further commercial and development activities[3].

Threats

• Competitive Pressure: The rare disease market is competitive, and new approvals, such as AQNEURSA in the NPC market, could pose challenges to OLPRUVA's market share[3].
• Regulatory Challenges: Regulatory hurdles for pipeline products could delay or impact their approval and commercialization[3].

Key Takeaways

• Launch and Market Access: OLPRUVA was launched commercially at the end of January 2024, with significant market access achieved by May 2024.
• Challenges: Despite progress, OLPRUVA faces challenges such as low patient awareness and initial reimbursement issues.
• Financial Outlook: Zevra Therapeutics has a solid financial position, with a cash runway extending into 2026 or 2027, supporting ongoing commercial activities.
• Strategic Focus: The company is focused on enhancing commercial infrastructure, advancing pipeline products, and potentially monetizing the PRV.

Frequently Asked Questions (FAQs)

1. What is OLPRUVA used for? OLPRUVA is used for the treatment of urea cycle disorders (UCDs), a group of rare genetic disorders.

2. When was OLPRUVA commercially launched? OLPRUVA was commercially launched at the end of January 2024.

3. What are the main challenges faced by OLPRUVA? The main challenges include low patient awareness and initial reimbursement issues.

4. How much reimbursement coverage has OLPRUVA achieved? As of May 1, 2024, OLPRUVA has achieved market access for nearly 75% of covered lives.

5. What are the projected peak sales for OLPRUVA? Analysts project peak sales of approximately $100 million by 2030.

Cited Sources:

1. Zevra Therapeutics Reports First Quarter 2024 Financial Results and Corporate Updates - [Zevra Therapeutics][1]
2. ZVRA Q4-2023 Earnings Call - [Alpha Spread][2]
3. Zevra Therapeutics' SWOT analysis - [Investing.com][3]
4. Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates - [Zevra Therapeutics][4]