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OXBRYTA Drug Patent Profile

When do Oxbryta patents expire, and what generic alternatives are available?

Oxbryta is a drug marketed by Global Blood Theraps and is included in two NDAs. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-seven patent family members in forty countries.

The generic ingredient in OXBRYTA is voxelotor. One supplier is listed for this compound. Additional details are available on the voxelotor profile page.

DrugPatentWatch^® Generic Entry Outlook for Oxbryta

Oxbryta was eligible for patent challenges on November 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 6, 2035. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for OXBRYTA

International Patents:	277
US Patents:	11
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	5
Patent Applications:	98
Drug Prices:	Drug price information for OXBRYTA
What excipients (inactive ingredients) are in OXBRYTA?	OXBRYTA excipients list
DailyMed Link:	OXBRYTA at DailyMed

See drug prices for OXBRYTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OXBRYTA

Constraining patent/regulatory exclusivity:

10,493,035

NDA:

213137

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

9,447,071

NDA:

216157

Dosage:

TABLET, FOR SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OXBRYTA

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

Sponsor	Phase
Pfizer	Phase 1
Global Blood Therapeutics	Phase 2
Emory University	Phase 2

See all OXBRYTA clinical trials

Pharmacology for OXBRYTA

Drug Class	Hemoglobin S Polymerization Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors

Paragraph IV (Patent) Challenges for OXBRYTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXBRYTA	Tablets	voxelotor	300 mg and 500 mg	213137	2	2023-11-27
OXBRYTA	Tablets for Oral Suspension	voxelotor	300 mg	216157	1	2023-11-27

US Patents and Regulatory Information for OXBRYTA

OXBRYTA is protected by thirteen US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,447,071.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No	10,017,491		Y
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No	11,020,382
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-001	Nov 25, 2019		DISCN	Yes	No
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-002	Oct 14, 2022		DISCN	Yes	No
Global Blood Theraps	OXBRYTA	voxelotor	TABLET;ORAL	213137-002	Oct 14, 2022		DISCN	Yes	No

EU/EMA Drug Approvals for OXBRYTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Oxbryta	Voxelotor	EMEA/H/C/004869 Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.	Authorised	no	no	yes	2022-02-14

International Patents for OXBRYTA

When does loss-of-exclusivity occur for OXBRYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OXBRYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	PA2022517
Peru	20160179	POLIMORFOS CRISTALINOS DE LA BASE LIBRE DE 2-HIDROXI-6-((2-(1-ISOPROPIL-1H-PIRAZOL-5-IL)PIRIDIN-3-IL)METOXI)BENZALDEHIDO
Taiwan	202037593	Compounds and uses thereof for the modulation of hemoglobin
Denmark	3738434
Singapore	11201510135X	CRYSTALLINE POLYMORPHS OF THE FREE BASE OF 2-HYDROXY-6-((2-(1-ISOPROPYL-1H-PYRAZOL-5-YL)PYRIDIN-3-YL)METHOXY)BENZALDEHYDE

Supplementary Protection Certificates for OXBRYTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2797416	122022000052	Germany		PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 20220214
2797416	LUC00276	Luxembourg		PRODUCT NAME: VOXELOTOR OR A TAUTOMER OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/21/1622 20220215
2797416	301191	Netherlands		PRODUCT NAME: VOXELOTOR OF EEN TAUTOMEER OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1622 20220215
2797416	32/2022	Austria		PRODUCT NAME: VOXELOTOR ODER EIN TAUTOMER ODER PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1622 (MITTEILUNG) 20220215
2797416	22C1042	France		PRODUCT NAME: VOXELOTOR OU UN TAUTOMERE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1622 20220215

OXBRYTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxbryta

Introduction

Oxbryta, a drug developed for the treatment of sickle cell disease (SCD), has been at the center of significant market and financial developments, particularly following its acquisition by Pfizer and its subsequent withdrawal from the market.

Approval and Initial Market Performance

Oxbryta, an orally available hemoglobin S polymerization inhibitor, was approved by the FDA in November 2019 for the treatment of SCD. Initially owned by Global Blood Therapeutics (GBT), the drug showed promising sales figures. In the fourth quarter of 2021, Oxbryta generated $56.1 million in net sales, marking a 36% increase year over year. For the full year 2021, the drug achieved $194.7 million in net sales, a 57% increase from the previous year[2].

Acquisition by Pfizer

In 2022, Pfizer acquired GBT for $5.4 billion, with high expectations for Oxbryta's future success. The acquisition was seen as a strategic move to bolster Pfizer's presence in the SCD market. At the time of acquisition, analysts predicted that Oxbryta could reach sales of up to $750 million by the end of the decade[1][3].

Financial Performance Under Pfizer

Under Pfizer, Oxbryta continued to generate significant revenue. In 2023, global sales of Oxbryta reached $328 million. However, this was slightly below the expectations of some analysts, who had forecast around $400 million in annual revenue[1].

Market Withdrawal

The trajectory of Oxbryta took a dramatic turn with Pfizer's decision to withdraw the drug from the global market. This decision was based on new safety data indicating a higher risk of deaths and complications, including vaso-occlusive crises, in treated patients. The data showed that the overall benefit of Oxbryta no longer outweighed the risks associated with its use[3][4].

Impact on Patients and Healthcare Providers

The withdrawal of Oxbryta has left patients and healthcare providers with limited treatment options. Patients who were on Oxbryta are advised to discuss alternative treatments with their physicians. For the milder population of SCD patients, options include Novartis’ Adakveo and Emmaus Medical’s Endari, although Adakveo has also faced scrutiny in Europe[1].

Financial Implications

Despite the significant investment in Oxbryta, Pfizer does not expect the withdrawal to have a material impact on its fiscal year 2024 guidance. However, the financial implications are not entirely negligible. The withdrawal has led to a modest decline in Pfizer's stock price and has increased investor frustrations with the company's business development track record. Guggenheim Securities analysts noted that the financial impact is "somewhat modest" but highlighted that it will likely raise questions about Pfizer's ability to grow through the 2025-2030 period[1][4].

Regulatory and Market Impact

The withdrawal of Oxbryta could also impact the regulatory path for other SCD treatments. For instance, Leerink Partners noted that regulatory agencies may become more vigilant about demonstrating a vaso-occlusive crisis benefit or strong trend in pivotal trials for other drugs, including those from Agios and Fulcrum[1].

Alternative Treatment Options

The recent FDA approvals of gene therapies such as bluebird bio’s Lyfgenia and Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy offer new hope for SCD patients. However, these therapies are currently limited to the sickest patients and may face increased scrutiny due to the safety concerns raised by Oxbryta's withdrawal[1][4].

Future Outlook

The withdrawal of Oxbryta marks a significant setback for Pfizer's ambitions in the SCD market. While the company does not anticipate a major financial impact, the decision underscores the challenges and uncertainties inherent in drug development and market dynamics. Other biotechs, such as Fulcrum, may see increased interest in their trials as patients seek alternative treatments[1][3].

Key Takeaways

• Market Withdrawal: Oxbryta was withdrawn from the global market due to new safety data showing a higher risk of deaths and complications.
• Financial Impact: The withdrawal is expected to have a modest financial impact on Pfizer but has raised concerns about the company's business development track record.
• Patient Impact: Patients are left with limited treatment options, including Adakveo and Endari.
• Regulatory Impact: The withdrawal may lead to increased regulatory scrutiny for other SCD treatments.
• Alternative Treatments: Gene therapies like Lyfgenia and Casgevy offer new hope but are currently limited to the sickest patients.

FAQs

1. Why was Oxbryta withdrawn from the market? Oxbryta was withdrawn due to new safety data indicating a higher risk of deaths and complications, including vaso-occlusive crises, in treated patients[3][4].

2. What were the financial expectations for Oxbryta before its withdrawal? Analysts had predicted that Oxbryta could reach sales of up to $750 million by the end of the decade. In 2023, the drug generated $328 million in global sales[1].

3. What are the alternative treatment options for SCD patients after Oxbryta's withdrawal? Alternative options include Novartis’ Adakveo and Emmaus Medical’s Endari. Gene therapies like Lyfgenia and Casgevy are also available but are currently limited to the sickest patients[1].

4. How will the withdrawal of Oxbryta impact Pfizer's financial outlook? Pfizer does not expect the withdrawal to have a material impact on its fiscal year 2024 guidance, although it may increase investor frustrations with the company's business development track record[1][4].

5. What is the potential impact on other SCD treatments due to Oxbryta's withdrawal? The withdrawal may lead to increased regulatory scrutiny for other SCD treatments, with agencies potentially becoming more vigilant about demonstrating a vaso-occlusive crisis benefit or strong trend in pivotal trials[1].

Sources

1. Biospace - Pfizer's Oxbryta Withdrawal Leaves Sickle Cell Community Scrambling, Investors Reeling
2. Biospace - GBT Reports Fourth Quarter and Full Year 2021 Financial Results
3. Synapse - Pfizer's $5.4B Acquisition of Sickle Cell Drug OXBRYTA Withdrawn: Patient Risks Surge
4. Biospace - Pfizer Takes Sickle Cell Drug Oxbryta Off Global Market, Cites Risk of Death
5. Biospace - GBT Reports First Quarter 2022 Financial Results