OMACETAXINE MEPESUCCINATE - Generic Drug Details

What are the generic sources for omacetaxine mepesuccinate and what is the scope of patent protection?

Omacetaxine mepesuccinate is the generic ingredient in one branded drug marketed by Teva Pharms Intl and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omacetaxine mepesuccinate has twenty-one patent family members in twelve countries.

There are two drug master file entries for omacetaxine mepesuccinate.

Summary for OMACETAXINE MEPESUCCINATE

International Patents:	21
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	16
Patent Applications:	3,648
What excipients (inactive ingredients) are in OMACETAXINE MEPESUCCINATE?	OMACETAXINE MEPESUCCINATE excipients list
DailyMed Link:	OMACETAXINE MEPESUCCINATE at DailyMed

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

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 OMACETAXINE MEPESUCCINATE

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
University of Colorado, Denver	Phase 1/Phase 2
The University of Hong Kong	Phase 2

See all OMACETAXINE MEPESUCCINATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for OMACETAXINE MEPESUCCINATE

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OMACETAXINE MEPESUCCINATE

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 OMACETAXINE MEPESUCCINATE

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 OMACETAXINE MEPESUCCINATE

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 OMACETAXINE MEPESUCCINATE

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)

OMACETAXINE MEPESUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omacetaxine Mepesuccinate

Introduction

Omacetaxine mepesuccinate, marketed under the brand name Synribo, is a cephalotaxine used in the treatment of Chronic Myeloid Leukemia (CML) in patients who are intolerant or resistant to two or more tyrosine kinase inhibitors (TKIs). Here, we delve into the market dynamics and financial trajectory of this critical oncology drug.

FDA Approval and Regulatory Milestones

Omacetaxine mepesuccinate received accelerated approval from the FDA in October 2012 for the treatment of adult patients with chronic or accelerated phase CML who have resistance and/or intolerance to two or more TKIs. This approval was based on positive results from two open-label, single-arm Phase II trials. The full FDA approval was granted in February 2014 after the completion of the 24-month post-marketing commitment[1][3][5].

Market Need and Target Population

The drug addresses a significant unmet need in the CML treatment landscape, particularly for patients who have failed or are intolerant to TKIs. CML is a type of cancer that affects the white blood cells and tends to progress slowly over time. The presence of the BCR-ABL1T315I mutation, which is highly resistant to TKIs like imatinib, nilotinib, and dasatinib, makes omacetaxine mepesuccinate a valuable treatment option[2][4].

Clinical Efficacy and Safety Profile

Clinical trials have demonstrated the efficacy of omacetaxine mepesuccinate in achieving major cytogenetic responses (MCyR) in chronic phase CML and major hematologic responses (MHR) in accelerated phase CML. The drug has shown activity against the T315I mutation, a significant advantage over traditional TKIs. However, it is associated with significant adverse effects, including myelosuppression, bleeding, hyperglycemia, and fetal harm, which necessitate careful patient selection and monitoring[2][4][5].

Market Competition

The CML treatment market is dominated by TKIs, but omacetaxine mepesuccinate fills a niche as a third-line treatment option. Its unique mechanism of action as a protein synthesis inhibitor sets it apart from TKIs, providing an alternative for patients who have exhausted other treatment options. This differentiation helps in maintaining a competitive edge in the market[5].

Pricing and Reimbursement

The pricing of omacetaxine mepesuccinate is a critical factor in its market dynamics. Given its niche position and the high unmet need it addresses, the drug is typically priced at a premium. Reimbursement policies vary by region and insurance provider, but the drug's FDA approval and orphan drug designation have facilitated its inclusion in many reimbursement programs, making it more accessible to patients[3][5].

Sales Performance and Revenue

Since its approval, Synribo has generated significant revenue for Teva Pharmaceutical Industries Ltd. The drug's sales have been driven by its unique clinical profile and the lack of alternative treatments for CML patients resistant to TKIs. While exact sales figures are not publicly disclosed in the sources, the drug's approval and continued use indicate a stable revenue stream for Teva[1].

Clinical Trials and Pipeline

Omacetaxine mepesuccinate is being explored in various clinical trials beyond its approved indications. Phase I and II trials are ongoing for its use in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS), among other conditions. These trials aim to expand the drug's potential uses and further solidify its position in the oncology market[2][5].

Patient and Provider Education

The complex safety profile of omacetaxine mepesuccinate necessitates thorough education for both healthcare providers and patients. This includes detailed information on potential adverse effects, monitoring requirements, and the logistics of administration, whether in a clinical setting or at home. Effective education programs are crucial for maximizing the drug's benefits while minimizing its risks[4].

Logistics and Administration

The administration of omacetaxine mepesuccinate, typically via subcutaneous injection, involves careful planning and patient selection. The drug's half-life of about 6 hours and the need for frequent dosing (e.g., every 12 hours for 3 consecutive days) add to the complexity of its use. This complexity can impact patient compliance and healthcare resource utilization[5].

Financial Impact on Healthcare Systems

The financial impact of omacetaxine mepesuccinate on healthcare systems is multifaceted. While the drug is expensive, it offers a valuable treatment option for patients who would otherwise have limited choices. The reduction in healthcare costs associated with managing complications from untreated or undertreated CML can offset some of the drug's costs. Additionally, the improvement in patient outcomes and quality of life contributes to the overall economic benefit[4].

Future Outlook

The future outlook for omacetaxine mepesuccinate is promising, driven by ongoing clinical trials and its established position in the CML treatment landscape. As more data become available from these trials, the drug's potential uses are likely to expand, further enhancing its market dynamics and financial trajectory.

Key Takeaways

• FDA Approval: Omacetaxine mepesuccinate received accelerated and full FDA approval for treating CML patients resistant or intolerant to two or more TKIs.
• Clinical Efficacy: The drug has shown significant efficacy in achieving MCyR and MHR in CML patients, including those with the T315I mutation.
• Market Need: It addresses a critical unmet need in the CML treatment landscape.
• Pricing and Reimbursement: Priced at a premium, with reimbursement facilitated by FDA approval and orphan drug designation.
• Sales Performance: Generates significant revenue for Teva, driven by its unique clinical profile.
• Clinical Trials: Ongoing trials aim to expand its uses beyond CML.
• Patient and Provider Education: Critical for safe and effective use due to its complex safety profile.

FAQs

Q: What is omacetaxine mepesuccinate used for? A: 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)[3].

Q: How is omacetaxine mepesuccinate administered? A: The drug is administered via subcutaneous injection, typically every 12 hours for 3 consecutive days on a 4- to 7-week schedule[2][4].

Q: What are the common side effects of omacetaxine mepesuccinate? A: Common side effects include myelosuppression, bleeding, hyperglycemia, fetal harm, low platelet counts, low red and white blood cell counts, diarrhea, nausea, fatigue, and injection site reactions[3][4].

Q: Is omacetaxine mepesuccinate effective against the T315I mutation? A: Yes, omacetaxine mepesuccinate has shown activity against the T315I mutation, which is highly resistant to traditional TKIs[2][4].

Q: Are there ongoing clinical trials for omacetaxine mepesuccinate? A: Yes, ongoing clinical trials are exploring its use in conditions such as acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS)[2][5].

Sources

1. Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection. Teva Pharmaceutical Industries Ltd.
2. Omacetaxine Mepesuccinate (Synribo) - Medical Clinical Policy Bulletins. Aetna.
3. Omacetaxine mepesuccinate. Leukemia and Lymphoma Society.
4. Omacetaxine Mepesuccinate (Synribo) National Drug Monograph. Department of Veterans Affairs.
5. Omacetaxine mepesuccinate: Uses, Interactions, Mechanism of Action. DrugBank.