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SYNRIBO Drug Patent Profile

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

Synribo is a drug marketed by Teva Pharms Intl and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in twelve countries.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.

DrugPatentWatch^® Generic Entry Outlook for Synribo

Synribo was eligible for patent challenges on October 26, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for SYNRIBO

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	7
Patent Applications:	1,495
Drug Prices:	Drug price information for SYNRIBO
What excipients (inactive ingredients) are in SYNRIBO?	SYNRIBO excipients list
DailyMed Link:	SYNRIBO at DailyMed

See drug prices for SYNRIBO

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

NDA:

203585

Dosage:

POWDER;SUBCUTANEOUS

^*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 SYNRIBO

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
University of Florida	Phase 1/Phase 2
Teva Pharmaceutical Industries, Ltd.	Phase 1/Phase 2

See all SYNRIBO clinical trials

Paragraph IV (Patent) Challenges for SYNRIBO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNRIBO	for Injection	omacetaxine mepesuccinate	3.5 mg/vial	203585	1	2016-10-26

US Patents and Regulatory Information for SYNRIBO

SYNRIBO is protected by one US patents.

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
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012		DISCN	Yes	No

Expired US Patents for SYNRIBO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012

International Patents for SYNRIBO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2459822	TRAITEMENT DE LA LEUCEMIE MYELOIDE CHRONIQUE, RESISTANTE OU INTOLERANTE AU STI571, IMPLIQUANT L'HOMOHARRINGTONINE SEUL OU EN COMBINAISON AVEC D'AUTRES AGENTS (TREATMENT OF CHRONIC MYELOGENOUS LEUKEMIA, RESISTANT OR INTOLERANT TO STI571, INVOLVING HOMOHARRINGTONINE ALONE OR COMBINED WITH OTHER AGENTS)
Japan	2005508896
European Patent Office	2177223	Homoharringtonine seule ou en combinaison avec d'autres agents pour une utilisation dans le traitement des leucémies myélogènes chroniques résistantes ou intolérantes aux inhibiteurs de protéine kinase à l'exception du STI 571 (Homoharringtonine alone or combined with other agents for use in treating chronic myelogenous leukemia resistant or intolerant to protein kinase inhibitors other than STI 571)
France	2776292	CEPHALOTAXANES PORTEURS DE CHAINE LATERALE ET LEUR PROCEDE DE SYNTHESE
World Intellectual Property Organization (WIPO)	03020252

SYNRIBO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SYNRIBO (Omacetaxine Mepesuccinate)

Introduction

SYNRIBO (omacetaxine mepesuccinate) is a significant addition to the treatment arsenal for chronic myeloid leukemia (CML), particularly for patients who have failed or are intolerant to tyrosine kinase inhibitors (TKIs). Here, we delve into the market dynamics and financial trajectory of this drug.

FDA Approval and Regulatory Environment

SYNRIBO received accelerated approval from the FDA in October 2012 for the treatment of adult patients with Philadelphia chromosome-positive CML who have progressed after treatment with at least two prior TKIs. This approval was based on response rate as a surrogate endpoint under the FDA's Accelerated Approval Program[2][4].

Clinical Trials and Efficacy

The approval was supported by data from two Phase II clinical trials that evaluated the efficacy and safety of omacetaxine mepesuccinate in patients with chronic phase (CP) and accelerated phase (AP) CML. These trials demonstrated significant response rates, with 18% of patients in the chronic phase achieving a major cytogenetic response (MCyR) and 14% of patients in the accelerated phase achieving a major hematologic response (MaHR)[2][4].

Market Need and Competition

The CML treatment landscape has seen significant advancements with the availability of TKIs, but there remains an unmet need for patients who fail or are intolerant to these treatments. SYNRIBO fills this gap by offering a new treatment option for these patients. The market for CML treatments is competitive, with other drugs like bosutinib (Bosulif) also approved around the same time, but SYNRIBO's unique mechanism as a protein synthesis inhibitor sets it apart[2].

Safety and Adverse Reactions

While SYNRIBO offers a critical treatment option, it is associated with significant adverse reactions, including severe myelosuppression, thrombocytopenia, neutropenia, and anemia. These side effects necessitate close monitoring and management, which can impact its market adoption and patient compliance[1][5].

Dosage and Administration

The drug is administered subcutaneously, with a recommended starting schedule of 1.25 mg/m² twice daily for 14 consecutive days every 28 days during the induction phase, and 7 consecutive days every 28 days during the maintenance phase. This dosing regimen can influence patient adherence and healthcare provider preference[5].

Manufacturing and Distribution

SYNRIBO is manufactured by Teva Pharmaceutical Industries Ltd., one of the largest pharmaceutical companies globally. Teva's extensive presence in over 60 countries and its diverse product portfolio enhance the drug's accessibility and market reach[4].

Financial Performance

Teva Pharmaceutical Industries, the manufacturer of SYNRIBO, has a robust financial profile. In 2011, the company achieved a net revenue of about $18.3 billion. While specific financial data for SYNRIBO is not detailed, its inclusion in Teva's oncology portfolio contributes to the company's overall revenue and market position[4].

Market Impact and Patient Access

The approval of SYNRIBO has expanded treatment options for CML patients, particularly those who have limited alternatives. However, the high cost associated with specialty drugs like SYNRIBO can create barriers to access. Financial and non-financial support services often play a crucial role in making such drugs more accessible to patients[3].

Future Outlook

Given the ongoing need for effective treatments in CML, especially for patients resistant or intolerant to TKIs, SYNRIBO is likely to maintain a significant market presence. Continuous monitoring of its safety profile and efficacy, along with potential adjustments in dosing or administration, could further enhance its market dynamics.

Key Takeaways

• FDA Approval: SYNRIBO received accelerated FDA approval in 2012 for CML patients resistant or intolerant to TKIs.
• Clinical Efficacy: Demonstrated significant response rates in Phase II trials.
• Market Need: Fills an unmet need for CML patients who fail TKI treatments.
• Safety Profile: Associated with severe myelosuppression and other adverse reactions.
• Manufacturing and Distribution: Produced by Teva Pharmaceutical Industries Ltd., with global distribution.
• Financial Impact: Contributes to Teva's overall revenue, though specific figures are not detailed.

FAQs

What is SYNRIBO used for?

SYNRIBO (omacetaxine mepesuccinate) is used for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) who are resistant or intolerant to two or more tyrosine kinase inhibitors (TKIs)[1][2].

How is SYNRIBO administered?

SYNRIBO is administered subcutaneously, with a recommended starting schedule of 1.25 mg/m² twice daily for 14 consecutive days every 28 days during the induction phase, and 7 consecutive days every 28 days during the maintenance phase[5].

What are the common adverse reactions associated with SYNRIBO?

Common adverse reactions include severe myelosuppression (thrombocytopenia, neutropenia, anemia), injection site reactions, diarrhea, nausea, fatigue, and infections[1][5].

Who manufactures SYNRIBO?

SYNRIBO is manufactured by Teva Pharmaceutical Industries Ltd.[1][4].

What is the significance of SYNRIBO in the CML treatment landscape?

SYNRIBO provides a new treatment option for CML patients who have failed or are intolerant to TKIs, addressing an unmet medical need in this patient population[2].

How does SYNRIBO's approval impact patient access to CML treatments?

The approval of SYNRIBO expands treatment options for CML patients, but its high cost may necessitate financial and non-financial support services to enhance patient access[3].