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Amantadine hydrochloride - Generic Drug Details
What are the generic sources for amantadine hydrochloride and what is the scope of freedom to operate?
Amantadine hydrochloride
is the generic ingredient in five branded drugs marketed by Adamas Pharma, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Heritage Pharma, Invagen Pharms, Lannett Co Inc, Sandoz, Strides Pharma, Upsher Smith Labs, Watson Labs, Watson Labs Inc, Zydus Pharms, Solvay, Endo Pharms, Anda Repository, Cmp Pharma Inc, G And W Labs Inc, Hi Tech Pharma, Pharm Assoc, Teva Pharms, Vintage, Wockhardt Bio Ag, Osmotica Pharm, and Jubilant Generics, and is included in thirty-two NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amantadine hydrochloride has thirty-four patent family members in ten countries.
There are seven drug master file entries for amantadine hydrochloride. Thirty suppliers are listed for this compound.
Summary for amantadine hydrochloride
| International Patents: | 34 |
| US Patents: | 22 |
| Tradenames: | 5 |
| Applicants: | 25 |
| NDAs: | 32 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 30 |
| Bulk Api Vendors: | 127 |
| Clinical Trials: | 91 |
| Patent Applications: | 2,358 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for amantadine hydrochloride |
| DailyMed Link: | amantadine hydrochloride at DailyMed |
Recent Clinical Trials for amantadine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | N/A |
| The Affiliated Hospital of Qingdao University | N/A |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
Recent Litigation for amantadine hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ADAMAS PHARMA, LLC v. SANDOZ INC. | 2018-05-10 |
| Osmotica Pharmaceutical US LLC v. Adamas Pharmaceuticals, Inc. | 2018-02-16 |
Pharmacology for amantadine hydrochloride
| Drug Class | Influenza A M2 Protein Inhibitor |
| Mechanism of Action | M2 Protein Inhibitors |
Medical Subject Heading (MeSH) Categories for amantadine hydrochloride
Synonyms for amantadine hydrochloride
| (3R,5S,7s)-Adamantan-1-amine hydrochloride |
| (3s,5s,7s)-adamantan-1-amine hydrochloride |
| 1-Adamantanamin Hydrochlorid |
| 1-Adamantanamine HCl |
| 1-Adamantanamine hydrochloride |
| 1-Adamantanamine hydrochloride, 99+% |
| 1-Adamantanamine hydrochloride; 1-Adamantylamine hydrochloride; 1-Aminoadamantane hydrochloride |
| 1-Adamantanamine, hydrochloride |
| 1-Adamantanaminehydrochloride |
| 1-Adamantylamine hydrochloride |
| 1-aminoada- mantane hydrochloride |
| 1-Aminoadamantane hydrochloride |
| 1-Aminoadamantene hydrochloride |
| 13878-11-0 |
| 665-66-7 |
| 768-94-5 (Parent) |
| A 1260 |
| A0588 |
| A3A501 |
| AB0014024 |
| AB1008533 |
| AC-8689 |
| AC1L20JO |
| ACMC-209nvq |
| Adamantamine hydrochloride |
| adamantan-1-amine hydrochloride |
| adamantan-1-amine;hydrochloride |
| adamantan-1-aminium chloride |
| Adamantanamine HCl |
| Adamantanamine hydrochloride |
| adamantanylamine, chloride |
| Adamantine hydrochloride |
| adamantyl amine hydrochloride |
| Adamantylamine hydrochloride |
| Adamin |
| Adamine |
| ADS-5101 |
| ADS-5102 |
| AI3-52211 |
| AK-40714 |
| AKOS015900347 |
| AKOS015951188 |
| Amantadine (hydrochloride) |
| Amantadine HCl |
| Amantadine hydrochloride (JP17/USP) |
| Amantadine hydrochloride (Symmetrel) |
| Amantadine hydrochloride [USAN:JAN] |
| Amantadine hydrochloride [USAN:USP:JAN] |
| Amantadine hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Amantadine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Amantadine hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Amantan |
| amantidine hydrochloride |
| Amazolon |
| Aminoadamantane hydrochloride |
| AN-7740 |
| ANW-35220 |
| AOB5792 |
| BC204764 |
| BCP11857 |
| C07939 |
| CA-1982 |
| CCG-38899 |
| Cerebramed |
| CHEBI:2619 |
| CHEMBL1255870 |
| CHEMBL1569 |
| CPD001370746 |
| CS-2502 |
| CTK2F3028 |
| D00777 |
| EBD2156754 |
| EC 211-560-2 |
| EINECS 211-560-2 |
| EU-0100004 |
| EXP 105-1 |
| Exp-105-1 |
| F3111-1111 |
| FT-0622248 |
| GP 38026 |
| HMS1920A19 |
| Hofcomant |
| HY-B0402A |
| I14-0454 |
| Influenol |
| J-650095 |
| J-650235 |
| K091 |
| KB-11068 |
| KS-000009I7 |
| KSC353A2R |
| LP00004 |
| LS-14931 |
| Lysovir |
| M6Q1EO9TD0 |
| Mantadan |
| Mantadine |
| Mantadix |
| MCULE-2948891352 |
| MFCD00074723 |
| MFCD00074723 (98%) |
| Midantan |
| Midantane |
| MLS000028731 |
| MLS002153257 |
| MLS003899199 |
| MolPort-000-692-440 |
| MolPort-003-925-531 |
| MolPort-038-942-500 |
| Mydantane |
| N04BB01 |
| NC00489 |
| NCGC00093531-01 |
| NCGC00093531-02 |
| NCGC00093531-03 |
| NCGC00093531-04 |
| NCGC00260689-01 |
| NSC 83653 |
| NSC-755860 |
| NSC-83653 |
| NSC755860 |
| NSC83653 |
| Nurelin |
| Opera_ID_671 |
| Pharmakon1600-01500110 |
| PubChem6390 |
| Q-200621 |
| RTR-022507 |
| s2451 |
| SAM002554881 |
| SBB003680 |
| SC-06172 |
| SCHEMBL40713 |
| SMR000059204 |
| SMR001370746 |
| SPECTRUM1500110 |
| SR-01000075353 |
| SR-01000075353-1 |
| ST24032190 |
| ST50508424 |
| STR01017 |
| SW219892-1 |
| SY012930 |
| Symmetrel |
| Symmetrel (TN) |
| TL8004713 |
| Tox21_500004 |
| TR-022507 |
| TRA0093399 |
| Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, hydrochloride |
| Tricyclo(3.3.1.1(sup 3,7))decan-1-amine, hydrochloride (9CI) |
| Tricyclo(3.3.1.13,7)decan-1-amine, hydrochloride |
| Tricyclo[3.3.1.1 3,7]decan-1-amine hydrochloride |
| Tricyclo[3.3.1.13, hydrochloride |
| Tricyclo[3.3.1.13,7]decan-1-amine hydrochloride |
| Tricyclo[3.3.1.13,7]decan-1-amine, hydrochloride |
| Tricyclodecane |
| Trivaline |
| UNII-M6Q1EO9TD0 |
| V2452 |
| Virasol |
| Viregyt |
| Virofral |
| Virosol |
| WLN: L66 B6 A B- C 1B ITJ BZ &GH |
| WOLHOYHSEKDWQH-UHFFFAOYSA-N |
Paragraph IV (Patent) Challenges for AMANTADINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GOCOVRI | CAPSULE, EXTENDED RELEASE;ORAL | amantadine hydrochloride | 208944 | 2018-01-16 |
US Patents and Regulatory Information for amantadine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adamas Pharma | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-002 | Aug 24, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Anda Repository | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 074028-001 | Jun 28, 1993 | AA | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Adamas Pharma | GOCOVRI | amantadine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208944-001 | Aug 24, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Cmp Pharma Inc | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 075819-001 | Sep 11, 2002 | AA | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Vintage | AMANTADINE HYDROCHLORIDE | amantadine hydrochloride | SYRUP;ORAL | 077992-001 | Dec 12, 2006 | DISCN | No | 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 amantadine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-001 | Feb 16, 2018 | Start Trial | Start Trial |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-002 | Feb 16, 2018 | Start Trial | Start Trial |
| Osmotica Pharm | OSMOLEX ER | amantadine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209410-003 | Feb 16, 2018 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for amantadine hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2506709 | Start Trial |
| Japan | 2017019874 | Start Trial |
| Canada | 2589479 | Start Trial |
| Japan | 2009517332 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011069010 | Start Trial |
| Brazil | PI0515761 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verifification 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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