SYNRIBO Drug Patent Profile
✉ Email this page to a colleague
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SYNRIBO?
- What are the global sales for SYNRIBO?
- What is Average Wholesale Price for SYNRIBO?
Summary for SYNRIBO
| International Patents: | 21 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 69 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,494 |
| Drug Prices: | Drug price information for SYNRIBO |
| What excipients (inactive ingredients) are in SYNRIBO? | SYNRIBO excipients list |
| DailyMed Link: | SYNRIBO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SYNRIBO
*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 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYNRIBO is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SYNRIBO
Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharms Intl | SYNRIBO | omacetaxine mepesuccinate | POWDER;SUBCUTANEOUS | 203585-001 | Oct 26, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SYNRIBO
See the table below for patents covering SYNRIBO around the world.
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
