HYSINGLA ER Drug Patent Profile
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When do Hysingla Er patents expire, and when can generic versions of Hysingla Er launch?
Hysingla Er is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are twenty patents protecting this drug and two Paragraph IV challenges.
This drug has three hundred and fourteen 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. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.
DrugPatentWatch® 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.
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Summary for HYSINGLA ER
International Patents: | 314 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 18 |
Patent Applications: | 61 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HYSINGLA ER |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HYSINGLA ER |
What excipients (inactive ingredients) are in HYSINGLA ER? | HYSINGLA ER excipients list |
DailyMed Link: | HYSINGLA ER at DailyMed |
![HYSINGLA ER drug patent expirations Drug patent expirations by year for HYSINGLA ER](/p/graph/s/t/HYSINGLA_ER-patent-expirations.png)
![Drug Prices for HYSINGLA ER](/p/graph/drug-price/HYSINGLA+ER.png)
See drug prices for HYSINGLA ER
![Drug Sales Revenue Trends for HYSINGLA ER](/p/graph/drug-sales-revenues/HYSINGLA+ER.png)
Pharmacology for HYSINGLA ER
Drug Class | Opioid Agonist |
Mechanism of Action | Opioid Agonists |
Paragraph IV (Patent) Challenges for HYSINGLA ER
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
HYSINGLA ER | Extended-release Tablets | hydrocodone bitartrate | 30 mg, 40 mg, 80 mg, and 100 mg | 206627 | 1 | 2015-05-08 |
HYSINGLA ER | Extended-release Tablets | hydrocodone bitartrate | 20 mg, 60 mg, and 120 mg | 206627 | 1 | 2015-04-15 |
US Patents and Regulatory Information for HYSINGLA ER
HYSINGLA ER is protected by twenty US patents.
Patents protecting HYSINGLA ER
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Encased tamper resistant controlled release dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Encased tamper resistant controlled release dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Encased tamper resistant controlled release dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant controlled release dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Tamper resistant controlled release dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | 206627-004 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-006 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-003 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-002 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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 | 206627-002 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-007 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-006 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-005 | Nov 20, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HYSINGLA ER
See the table below for patents covering HYSINGLA ER around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103690540 | ⤷ Sign Up | |
Israel | 173558 | DOSAGE FORM THAT IS SAFEGUARDED FROM ABUSE | ⤷ Sign Up |
Hong Kong | 1054698 | ⤷ Sign Up | |
Chile | 2014001450 | Forma de dosis de liberacion controlada solida que comprende un analgesico opioide dispersado en un material de matriz; metodo de preparacion; uso en el tratamiento del dolor. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |