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.
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 |
Pharmacology for HYSINGLA ER
Drug Class | Opioid Agonist |
Mechanism of Action | Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for HYSINGLA ER
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Encased tamper resistant controlled release dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant controlled release dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Tamper resistant controlled release dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-006 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-003 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-002 | Nov 20, 2014 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | 206627-003 | Nov 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-002 | Nov 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-001 | Nov 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Purdue Pharma Lp | HYSINGLA ER | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-002 | Nov 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006082099 | ⤷ Try a Trial | |
Hong Kong | 1204560 | 包覆的抗篡改控制釋放劑型 (ENCASED TAMPER RESISTANT CONTROLLED RELEASE DOSAGE FORMS) | ⤷ Try a Trial |
China | 101027044 | Oral dosage form safeguarded against abuse | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2006002883 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |