DYANAVEL XR Drug Patent Profile
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Which patents cover Dyanavel Xr, and when can generic versions of Dyanavel Xr launch?
Dyanavel Xr is a drug marketed by Tris Pharma Inc and is included in two NDAs. There are ten patents protecting this drug.
This drug has twenty-one patent family members in fourteen countries.
The generic ingredient in DYANAVEL XR is amphetamine; amphetamine aspartate/dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amphetamine; amphetamine aspartate/dextroamphetamine sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Dyanavel Xr
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 15, 2027. This may change due to patent challenges or generic licensing.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
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Summary for DYANAVEL XR
| International Patents: | 21 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 2 |
| Patent Applications: | 6,697 |
| Drug Prices: | Drug price information for DYANAVEL XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DYANAVEL XR |
| What excipients (inactive ingredients) are in DYANAVEL XR? | DYANAVEL XR excipients list |
| DailyMed Link: | DYANAVEL XR at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DYANAVEL XR
*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 DYANAVEL XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Tris Pharma, Inc. | Phase 4 |
| Tris Pharma, Inc. | Phase 3 |
Pharmacology for DYANAVEL XR
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
US Patents and Regulatory Information for DYANAVEL XR
DYANAVEL XR is protected by seven US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DYANAVEL XR is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting DYANAVEL XR
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modified release formulations containing drug - ion exchange resin complexes
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tris Pharma Inc | DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Tris Pharma Inc | DYANAVEL XR 20 | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | TABLET, EXTENDED RELEASE;ORAL | 210526-004 | Nov 4, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Tris Pharma Inc | DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Tris Pharma Inc | DYANAVEL XR | amphetamine; amphetamine aspartate/dextroamphetamine sulfate | SUSPENSION, EXTENDED RELEASE;ORAL | 208147-001 | Oct 19, 2015 | RX | Yes | Yes | ⤷ 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 |
International Patents for DYANAVEL XR
When does loss-of-exclusivity occur for DYANAVEL XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 07227569
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 36867
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0709606
Patent: formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 45855
Patent: FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1400343
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Patent: 2488652
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 18160
Estimated Expiration: ⤷ Sign Up
Patent: 28205
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 18160
Patent: FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Estimated Expiration: ⤷ Sign Up
Patent: 28205
Patent: Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4042
Patent: פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 79086
Estimated Expiration: ⤷ Sign Up
Patent: 09530298
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 35569
Patent: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)
Estimated Expiration: ⤷ Sign Up
Patent: 08140944
Patent: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1495146
Estimated Expiration: ⤷ Sign Up
Patent: 080108520
Patent: MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 78573
Estimated Expiration: ⤷ Sign Up
Patent: 96039
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0812649
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering DYANAVEL XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2378573 | ⤷ Sign Up | |
| Austria | E536867 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2007109104 | ⤷ Sign Up | |
| Russian Federation | 2008140944 | КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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