DrugPatentWatch Database Preview
BELSOMRA Drug Profile
» See Plans and Pricing
When do Belsomra patents expire, and when can generic versions of Belsomra launch?
Belsomra is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.
This drug has seventy-five patent family members in thirty-seven countries.
The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this compound. Additional details are available on the suvorexant profile page.
US ANDA Litigation and Generic Entry Outlook for Belsomra
Belsomra was eligible for patent challenges on August 13, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 20, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for BELSOMRA
| International Patents: | 75 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Clinical Trials: | 26 |
| Patent Applications: | 226 |
| Drug Prices: | Drug price information for BELSOMRA |
| DailyMed Link: | BELSOMRA at DailyMed |
Generic Entry Opportunity Date for BELSOMRA
Generic Entry Date for BELSOMRA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 BELSOMRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Washington University School of Medicine | Phase 2 |
| Henry Ford Health System | Phase 2 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Phase 2 |
Pharmacology for BELSOMRA
| Drug Class | Orexin Receptor Antagonist |
| Mechanism of Action | Orexin Receptor Antagonists P-Glycoprotein Inhibitors Cytochrome P450 3A Inhibitors |
US Patents and Regulatory Information for BELSOMRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | BELSOMRA | suvorexant | TABLET;ORAL | 204569-001 | Aug 13, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | BELSOMRA | suvorexant | TABLET;ORAL | 204569-003 | Aug 13, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | BELSOMRA | suvorexant | TABLET;ORAL | 204569-002 | Aug 13, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Merck Sharp Dohme | BELSOMRA | suvorexant | TABLET;ORAL | 204569-004 | Aug 13, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for BELSOMRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2392572 | Start Trial |
| Honduras | 2009001067 | Start Trial |
| Russian Federation | 2561727 | Start Trial |
| South Korea | 20150014940 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
