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Betaxolol hydrochloride - Generic Drug Details
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What are the generic drug sources for betaxolol hydrochloride and what is the scope of freedom to operate?
Betaxolol hydrochloride
is the generic ingredient in six branded drugs marketed by Akorn, Apotex Inc, Medimetriks Pharms, Wockhardt, Sandoz Inc, Novartis, Epic Pharma, Kvk Tech, Sanofi Aventis Us, and Alcon, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for betaxolol hydrochloride. Seven suppliers are listed for this compound.
Summary for betaxolol hydrochloride
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 10 |
| NDAs: | 11 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 7 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 2 |
| Patent Applications: | 2,232 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | betaxolol hydrochloride at DailyMed |
Recent Clinical Trials for betaxolol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Minnesota - Clinical and Translational Science Institute | Phase 1 |
| Ohio State University | Phase 1 |
| University of Oklahoma | Phase 1 |
Pharmacology for betaxolol hydrochloride
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for betaxolol hydrochloride
Synonyms for betaxolol hydrochloride
| (+-)-1-(p-(2-(Cyclopropylmethoxy)ethyl)phenoxy)-3-(isopropylamino)-2-propanol hydrochloride |
| 1-(4-(2-(Cyclopropylmethoxy)ethyl)phenoxy)-3-isopropylaminopropan-2-ol hydrochloride |
| 1-(Isopropylamino)-3-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)propan-2-ol hydrochloride |
| 1-(isopropylamino)-3-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]propan-2-ol hydrochloride |
| 1-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)propan-2-ol hydrochloride |
| 1-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-(propan-2-ylamino)-2-propanol hydrochloride |
| 1-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-(propan-2-ylamino)propan-2-ol hydrochloride |
| 1-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-(propan-2-ylamino)propan-2-ol;hydrochloride |
| 1-[4-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-isopropylamino-2-propanol hydrochloride |
| 1-[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]-3-isopropylamino-2-propanolhydrochloride |
| 2-Propanol, 1-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl)amino)-, hydrochloride, (+-)- |
| 2-Propanol, 1-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl)amino)-,hydrochloride |
| 63659-18-7 (Parent) |
| 63659-19-8 |
| 659X198 |
| 72424-72-7 |
| A803574 |
| AB2000314 |
| AC-1412 |
| AC1L331T |
| AC1Q3DQ4 |
| AKOS015843993 |
| alo 1401-02 |
| AN-14973 |
| API0001701 |
| AS-18082 |
| B 5683 |
| B4474 |
| BC227944 |
| BCP02967 |
| BCP0726000249 |
| BCP9000394 |
| Betaxolo Hydrochloride |
| Betaxolol (hydrochloride) |
| Betaxolol for peak identification, European Pharmacopoeia (EP) Reference Standard |
| Betaxolol HCL |
| Betaxolol hydrochloride (Betoptic) |
| Betaxolol hydrochloride (JP17/USP) |
| Betaxolol hydrochloride [USAN:USP:JAN] |
| Betaxolol hydrochloride [USAN] |
| Betaxolol hydrochloride, >98% (HPLC) |
| Betaxolol hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Betaxolol hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Betaxolol(hydrochloride) |
| Betoptic |
| Betoptic (TN) |
| Betoptic S |
| Betoptima |
| BG0105 |
| CCG-101057 |
| CCG-213473 |
| CHDPSNLJFOQTRK-UHFFFAOYSA-N |
| CHEBI:643228 |
| CHEMBL1691 |
| CPD000058420 |
| CS-2453 |
| CTK8F0839 |
| D00598 |
| EINECS 264-384-3 |
| EU-0100193 |
| FT-0645228 |
| HMS1569M05 |
| HY-B0381A |
| I06-1154 |
| Kerlon |
| Kerlone |
| Kerlone (TN) |
| Kerlong |
| KS-00001F73 |
| Lokren |
| Lokren ,Kerlone ;Betoptic |
| LP00193 |
| LS-122006 |
| MCI-144 |
| MFCD00242959 |
| MLS000028464 |
| MLS000758269 |
| MLS000863279 |
| MLS001148209 |
| MLS001424199 |
| MLS002222261 |
| MolPort-003-666-823 |
| NC00307 |
| NCGC00093669-01 |
| NCGC00093669-02 |
| NCGC00260878-01 |
| NSC-760048 |
| NSC760048 |
| Opera_ID_878 |
| Pharmakon1600-01505512 |
| Prestwick_779 |
| Q-200714 |
| S1827 |
| SAM001247084 |
| SCHEMBL42794 |
| SL 75 212-10 |
| SL 75.212-10 |
| SL-75212 |
| SL-75212-10 |
| SMR000058420 |
| SR-01000000108 |
| SR-01000000108-2 |
| SR-01000000108-4 |
| SR-01000000108-9 |
| SW196917-4 |
| TC-071428 |
| Tox21_500193 |
| W0012 |
Paragraph IV (Patent) Challenges for BETAXOLOL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BETOPTIC | SOLUTION/DROPS;OPHTHALMIC | betaxolol hydrochloride | 019270 |
US Patents and Regulatory Information for betaxolol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alcon | BETOPTIC PILO | betaxolol hydrochloride; pilocarpine hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 020619-001 | Apr 17, 1997 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Akorn | BETAXOLOL HYDROCHLORIDE | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 075386-001 | Jun 30, 2000 | AT | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | KERLEDEX | betaxolol hydrochloride; chlorthalidone | TABLET;ORAL | 019807-002 | Oct 30, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Sanofi Aventis Us | KERLEDEX | betaxolol hydrochloride; chlorthalidone | TABLET;ORAL | 019807-001 | Oct 30, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Kvk Tech | BETAXOLOL HYDROCHLORIDE | betaxolol hydrochloride | TABLET;ORAL | 078962-001 | Jun 27, 2008 | AB | RX | 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 betaxolol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | BETOPTIC S | betaxolol hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 019845-001 | Dec 29, 1989 | Start Trial | Start Trial |
| Sandoz Inc | BETOPTIC | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019270-001 | Aug 30, 1985 | Start Trial | Start Trial |
| Sandoz Inc | BETOPTIC | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019270-001 | Aug 30, 1985 | Start Trial | Start Trial |
| Novartis | BETOPTIC S | betaxolol hydrochloride | SUSPENSION/DROPS;OPHTHALMIC | 019845-001 | Dec 29, 1989 | Start Trial | Start Trial |
| Sandoz Inc | BETOPTIC | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019270-001 | Aug 30, 1985 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.