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SOLOSEC Drug Profile
» See Plans and Pricing
When do Solosec patents expire, and when can generic versions of Solosec launch?
Solosec is a drug marketed by Lupin and is included in one NDA. There is one patent protecting this drug.
This drug has fourteen patent family members in five countries.
The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secnidazole profile page.
US ANDA Litigation and Generic Entry Outlook for Solosec
Solosec will be eligible for patent challenges on September 15, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 15, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SOLOSEC
| International Patents: | 14 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 78 |
| Clinical Trials: | 2 |
| Patent Applications: | 294 |
| Drug Prices: | Drug price information for SOLOSEC |
| DailyMed Link: | SOLOSEC at DailyMed |
Generic Entry Opportunity Date for SOLOSEC
Generic Entry Date for SOLOSEC*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW NDA:
Dosage:
GRANULE;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 SOLOSEC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lupin Research Inc | Phase 3 |
| Lupin Research Inc | Phase 4 |
Pharmacology for SOLOSEC
| Drug Class | Nitroimidazole Antimicrobial |
US Patents and Regulatory Information for SOLOSEC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | 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 SOLOSEC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2020019759 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2016037131 | Start Trial |
| Japan | 6487534 | Start Trial |
| South Korea | 20200013602 | Start Trial |
| Japan | 2017526697 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
