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HYSINGLA ER Drug Profile
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Which patents cover Hysingla Er, and what generic alternatives are available?
Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are thirty-eight patents protecting this drug and two Paragraph IV challenges.
This drug has six hundred and six patent family members in forty-nine countries.
The generic ingredient in HYSINGLA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
US ANDA Litigation and Generic Entry Outlook for Hysingla Er
A generic version of HYSINGLA ER was approved as hydrocodone bitartrate by ALVOGEN on January 21st, 2020.
Summary for HYSINGLA ER
| International Patents: | 606 |
| US Patents: | 38 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 8 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HYSINGLA ER |
| Drug Sales Revenues: | Drug sales revenues for HYSINGLA ER |
| DailyMed Link: | HYSINGLA ER at DailyMed |
See drug prices for HYSINGLA ER
Pharmacology for HYSINGLA ER
| Drug Class | Opioid Agonist |
| Mechanism of Action | Opioid Agonists |
Paragraph IV (Patent) Challenges for HYSINGLA ER
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| HYSINGLA ER | TABLET, EXTENDED RELEASE;ORAL | hydrocodone bitartrate | 206627 | 2015-05-08 |
| HYSINGLA ER | TABLET, EXTENDED RELEASE;ORAL | hydrocodone bitartrate | 206627 | 2015-04-15 |
US Patents and Regulatory Information for HYSINGLA ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-002 | Nov 20, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-007 | Nov 20, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-003 | Nov 20, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-007 | Nov 20, 2014 | RX | Yes | No | 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 |
Expired US Patents for HYSINGLA ER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-004 | Nov 20, 2014 | Start Trial | Start Trial |
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-005 | Nov 20, 2014 | Start Trial | Start Trial |
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-004 | Nov 20, 2014 | Start Trial | Start Trial |
| Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-004 | Nov 20, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HYSINGLA ER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2005501067 | Start Trial |
| Serbia | 52779 | Start Trial |
| Cyprus | 1110609 | Start Trial |
| Cyprus | 1117294 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
