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DYANAVEL XR Drug Profile
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Which patents cover Dyanavel Xr, and when can generic versions of Dyanavel Xr launch?
This drug has twenty-one patent family members in fourteen countries.
The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amphetamine profile page.
Summary for DYANAVEL XR
| International Patents: | 21 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 28 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,200 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DYANAVEL XR |
| DailyMed Link: | DYANAVEL XR at DailyMed |
Generic Entry Opportunity 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.
Pharmacology for DYANAVEL XR
| Drug Class | Central Nervous System Stimulant |
| Physiological Effect | Central Nervous System Stimulation |
Medical Subject Heading (MeSH) Categories for DYANAVEL XR
Synonyms for DYANAVEL XR
| .alpha.-Methylbenzeneethanamine |
| .alpha.-Methylbenzeneethaneamine |
| .alpha.-Methylphenethylamine |
| .alpha.-Methylphenethylamine, d-form |
| .alpha.-Methylphenylethylamine |
| .beta.-Aminopropylbenzene |
| .beta.-Phenylisopropylamin |
| .beta.-Phenylisopropylamine |
| (.+/-.)-.alpha.-Methylphenethylamine |
| (.+/-.)-.alpha.-Methylphenylethylamine |
| (.+/-.)-.beta.-Phenylisopropylamine |
| (.+/-.)-Benzedrine |
| (.+/-.)-Desoxynorephedrine |
| (+-)-alpha-Methylbenzeneethanamine |
| (+-)-alpha-Methylphenethylamine |
| (+-)-alpha-Methylphenylethylamine |
| (+-)-Benzedrine |
| (+)-.alpha.-Methylphenethylamine |
| (+)-.alpha.-Methylphenylethylamine |
| (+/-)-1-Phenyl-2-aminopropane |
| (+/-)-Amphetamine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| (+/-)-Amphetamine solution, 100 mug/mL in methanol, ampule of 1 mL, certified reference material |
| (Phenylisopropyl)amine |
| (plusmn)-amphetamine |
| (S)-.alpha.-Phenylethylamine |
| (S)-(+)-.beta.-Phenylisopropylamine |
| [1-(3-Methoxyphenyl)-2-propyl]amine |
| 1-benzylethylamine |
| 1-Methyl-2-phenylethylamine |
| 1-Phenyl-2-amino-propan |
| 1-Phenyl-2-amino-propan [German] |
| 1-Phenyl-2-aminopropane |
| 1-Phenyl-2-aminopropane (VAN) |
| 1-Phenyl-2-propanamine |
| 1-Phenyl-2-propylamine |
| 1-phenylpropan-2-amine |
| 17108-96-2 |
| 2-Amino-1-phenylpropane |
| 3-Phenyl-2-propylamine |
| 3-phenylpropan-2-amine |
| 300-62-9 |
| 3797-EP2275420A1 |
| 3797-EP2295439A1 |
| 3797-EP2298734A2 |
| 3797-EP2298742A1 |
| 3797-EP2298779A1 |
| 3797-EP2305219A1 |
| 3797-EP2305648A1 |
| 3797-EP2305656A1 |
| 3797-EP2308867A2 |
| 3797-EP2308870A2 |
| 3797-EP2311801A1 |
| 3797-EP2311802A1 |
| 3797-EP2311803A1 |
| 3797-EP2314571A2 |
| 3797-EP2371814A1 |
| 60-13-9 (sulfate (2:1)) |
| 60-15-1 |
| 96332-84-2 |
| AC1L1EYQ |
| AC1Q5065 |
| Actedron |
| Adderal |
| Adderall |
| Adderall XR |
| Adipan |
| Adzenys ER |
| AI3-02438 |
| AKOS022196414 |
| Allodene |
| alpha-methyl phenethylamine |
| ALPHA-METHYL-BENZENEETHANAMIDE (SEE ALSO DL-AMPHETAMINE SULFATE) |
| alpha-Methylbenzeneethanamine |
| alpha-Methylbenzeneethaneamine |
| alpha-Methylphenethylamine |
| alpha-Methylphenylethylamine |
| Amfetamin (TN) |
| Amfetamina [INN-Spanish] |
| Amfetamina [Italian] |
| Amfetamine |
| Amfetamine (INN) |
| Amfetamine [INN:BAN] |
| amfetaminum |
| Amfetaminum [INN-Latin] |
| Amphetamin |
| AMPHETAMINE |
| AMPHETAMINE (SEE ALSO: D-AMPHETAMINE (51-64-9) & AMPHETAMINE SULFATE (60-13-9)) |
| Amphetamine (tamper and abuse-resistant, Bio-MD/MPAR, ADHD) |
| Amphetamine (tamper and abuse-resistant, Bio-MD/MPAR, ADHD), PharmacoFore |
| Amphetamine resin complex |
| Amphetamine salts |
| Amphetamine Sulfate (2:1) |
| AMPHETAMINE, (D) |
| Amphetamine, its salts, optical isomers, and salts of its optical isomers |
| AN-23365 |
| Anfetamina [Spanish] |
| Anorexide |
| Anorexine |
| BDBM50005246 |
| Benzebar |
| Benzedrine |
| Benzeneethanamine, ?-methyl-, (+/-)- |
| Benzeneethanamine, .alpha.-methyl- |
| Benzeneethanamine, .alpha.-methyl-, (.+/-.)- |
| Benzeneethanamine, .alpha.-methyl-, (.alpha.S)- |
| Benzeneethanamine, .alpha.-methyl-, (S)- |
| Benzeneethanamine, (S)- |
| Benzeneethanamine, alpha-methyl- |
| Benzeneethanamine, alpha-methyl-, (+-)- |
| Benzolone |
| beta-Aminopropylbenzene |
| beta-Aminopropylbenzene (VAN) |
| beta-phenyl-isopropylamine |
| beta-Phenylisopropylamin |
| beta-Phenylisopropylamin [German] |
| beta-Phenylisopropylamine |
| C07514 |
| CHEBI:132233 |
| CHEBI:2679 |
| CHEMBL405 |
| component of Amodex |
| component of Biphetamine |
| d-.alpha.-Methylphenethylamine |
| d/l-Amphetamine hydrochloride |
| D/L-AMPHETAMINEHYDROCHLORIDE |
| D05BMG |
| D07445 |
| DB00182 |
| DEA No. 1100 |
| Desoxynorephedrin |
| Desoxynorephedrine |
| DivK1c_000991 |
| DL-.alpha.-Methylphenethylamine |
| dl-1-Phenyl-2-aminopropane |
| dl-alpha-Methylphenethylamine |
| dl-Amphetamine |
| DL-Amphetamine solution |
| DL-Amphetamine solution, 1 mg/mL in methanol, drug standard |
| DL-Amphetamine-d11 solution |
| dl-Benzedrine |
| DTXSID4022600 |
| EINECS 200-458-3 |
| EINECS 206-096-2 |
| Elastonon |
| Euphodyn (Salt/Mix) |
| Fabedrine (Salt/Mix) |
| Fenamin (Salt/Mix) |
| Fenopromin |
| Fenylo-izopropylaminyl |
| Fenylo-izopropylaminyl [Polish] |
| Finam |
| FT-0631912 |
| FT-0694835 |
| GTPL4804 |
| HMS503G03 |
| HSDB 3287 |
| IDI1_000991 |
| Isoamyne |
| Isomyn |
| KB-219221 |
| KB-50276 |
| KBio1_000991 |
| KWTSXDURSIMDCE-UHFFFAOYSA-N |
| L000864 |
| levo-Amphetamine |
| LS-1148 |
| LS-1428 |
| MCULE-4193952437 |
| Mecodrin |
| Mydrial |
| NINDS_000991 |
| Noclon (Salt/Mix) |
| Norephedrane |
| Norephedrine, deoxy- |
| Novydrine |
| NSC 27159 |
| NSC-27159 |
| NSC-73713 |
| NSC27159 |
| NSC73713 |
| NT-0201 |
| Oktedrin |
| Oprea1_447423 |
| OR038219 |
| OR255017 |
| Oraldrina (Salt/Mix) |
| Ortedrine |
| Ortenal (Salt/Mix) |
| Percomon |
| PF-08 (Bio-MD/MPAR/prodrug/oral, ADHD), PharmacoFore |
| Phenedrine |
| Phenethylamine, .alpha.-methyl- |
| Phenethylamine, .alpha.-methyl-, (.+/-.)- |
| Phenethylamine, (+)- |
| Phenethylamine, alpha-methyl- |
| Phenethylamine, alpha-methyl-, (+-)- |
| Phenethylamine, alpha-methyl, (+-)- |
| Phenethylamine, d- |
| Phenethylamine, D-.alpha.-methyl- |
| Profamina |
| Propisamine |
| Protioamphetamine |
| Psychedrine |
| rac-(2R)-1-phenylpropan-2-amine |
| rac-Amphetamine |
| rac-Amphetamine 1.0 mg/ml in Methanol |
| racemic-Desoxynor-ephedrine |
| Raphetamine |
| Rhinalator |
| SCHEMBL8858 |
| Simpatedrin |
| Simpatina |
| Stimulan (Salt/Mix) |
| Sympametin (Salt/Mix) |
| Sympamine |
| Sympatedrine |
| Thyramine |
| Vapedrine (Salt/Mix) |
| Weckamine |
| WLN: ZY1&1R |
| WLN: ZY1&1R -D |
| Zedrine (Salt/Mix) |
US Patents and Regulatory Information for DYANAVEL XR
| 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 | 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 | 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 | 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 | 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 |
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Non-Orange Book US Patents for DYANAVEL XR
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 9,198,864 | Modified release formulations containing drug-ion exchange resin complexes | ➤ Sign Up |
| 9,522,191 | Modified release formulations containing drug--ion exchange resin complexes | ➤ Sign Up |
| 8,202,537 | Modified release formulations containing drug-ion exchange resin complexes | ➤ Sign Up |
| 9,549,989 | Modified release formulations containing drug-ion exchange resin complexes | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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