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BEPREVE Drug Profile
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When do Bepreve patents expire, and when can generic versions of Bepreve launch?
Bepreve is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty-five patent family members in sixteen countries.
The generic ingredient in BEPREVE is bepotastine besilate. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bepotastine besilate profile page.
US ANDA Litigation and Generic Entry Outlook for Bepreve
A generic version of BEPREVE was approved as bepotastine besilate by MYLAN on January 24th, 2020.
Summary for BEPREVE
| International Patents: | 45 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 63 |
| Clinical Trials: | 5 |
| Patent Applications: | 15 |
| Drug Prices: | Drug price information for BEPREVE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BEPREVE |
| DailyMed Link: | BEPREVE at DailyMed |
Recent Clinical Trials for BEPREVE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Southern California College of Optometry | Phase 4 |
| McCabe Vision Center | N/A |
| Minnesota Eye Consultants, P.A. | Phase 4 |
Recent Litigation for BEPREVE
Identify potential future generic entrants
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals, Inc. | 2016-06-08 |
| Mylan Pharmaceuticals, Inc. | 2016-02-25 |
Pharmacology for BEPREVE
| Drug Class | Histamine-1 Receptor Antagonist |
Synonyms for BEPREVE
| (+)-(S)-4-(4-((4-Chlorophenyl)(2-pyridyl)methoxy)piperidino)butyric acid monobenzenesulfonate |
| (+)-(S)-4-[4-[1-(4-Chlorophenyl)-1-(2-pyridyl)methoxy]piperidin-1-yl]butyric acid benzenesulfonate |
| (S)-4-(4-((4-chlorophenyl)(pyridin-2-yl)methoxy)piperidin-1-yl)butanoic acid compound with benzenesulfonic acid (1:1) |
| (S)-4-[4-(4-Chlorophenyl-2-pyridylmethoxy)piperidinyl]butyric Acid Benzenesulfonate |
| (s)-4-[4-[(4-chlorophenyl)(2-pyridyl)-methoxy]piperidino]butanoic acid monobenzenesulfonic acid salt |
| (s)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butanoic acid monobenzenesulfonic acid salt |
| 1-Piperidinebutanoic acid, 4-((4-chlorophenyl)-2-pyridinylmethoxy)- (S)-, monobenzenesulfonate |
| 1-piperidinebutanoic acid, 4-[(4-chlorophenyl)-2-pyridinylmethoxy]-, (s)-, monobenzenesulfonate |
| 1-piperidinebutanoic acid, 4-[(s)-(4-chlorophenyl)-2-pyridinylmethoxy]-, monobenzenesulfonate |
| 190786-44-8 |
| 4-((4-Chlorophenyl)-2-pyridinylmethoxy)- (S)-1-piperidinebutanoic acid monobenzenesulfonate |
| 4-[(S)-(4-Chlorophenyl)-2-pyridinylmethoxy]-1-piperidinebutanoic Acid Benzenesulfonate |
| 4-[4-[(r)-(4-chlorophenyl)-pyridin-2-yl-methoxy]-1-piperidyl]butanoic acid |
| 4-{4-[(s)-(4-chlorophenyl)(pyridin-2-yl)methoxy]piperidin-1-yl}butanoic acid benzenesulfonate |
| 6W18MO1QR3 |
| 786B448 |
| ABP001064 |
| AC-24015 |
| AC1L4UXJ |
| AC1Q6WSY |
| AK322015 |
| AKOS025401655 |
| AN-5247 |
| API0001668 |
| AS-17863 |
| BC214879 |
| benzenesulfonic acid; 4-[4-[(S)-(4-chlorophenyl)-(2-pyridyl)methoxy]-1-piperidyl]butanoic acid |
| benzenesulfonic acid; 4-[4-[(S)-(4-chlorophenyl)-pyridin-2-ylmethoxy]piperidin-1-yl]butanoic acid |
| benzenesulfonic acid;4-[4-[(S)-(4-chlorophenyl)-pyridin-2-ylmethoxy]piperidin-1-yl]butanoic acid |
| Bepomax |
| Bepotastine (Beslilate) |
| Bepotastine benzenesulfonate |
| Bepotastine Benzenesulfonate Salt |
| Bepotastine besilate |
| Bepotastine besilate (JP17) |
| Bepotastine Besitate |
| Bepotastine Beslilat |
| Bepotastine besylate |
| Bepotastine besylate (USAN) |
| Bepotastine besylate [USAN] |
| Bepreve (TN) |
| Betotastine besilate |
| C27H31ClN2O6S |
| CB0259 |
| CHEBI:31281 |
| CHEMBL1201759 |
| CS-0383 |
| CTK4E0497 |
| D01654 |
| DTXSID80172577 |
| FT-0655883 |
| HY-A0015 |
| J-012325 |
| KS-00000FR0 |
| LS-114358 |
| MolPort-005-938-034 |
| PubChem19122 |
| s3037 |
| SB17505 |
| SC-47417 |
| SCHEMBL1287638 |
| SW220161-1 |
| Talion |
| Talion (TN) |
| Tau 284 |
| TAU-284 |
| tau284 |
| UDGHXQPQKQPSBB-BOXHHOBZSA-N |
| UNII-6W18MO1QR3 |
| V2224 |
| W-5279 |
Paragraph IV (Patent) Challenges for BEPREVE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BEPREVE | SOLUTION/DROPS;OPHTHALMIC | bepotastine besilate | 022288 | 2013-09-09 |
US Patents and Regulatory Information for BEPREVE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bausch And Lomb Inc | BEPREVE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 022288-001 | Sep 8, 2009 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Bausch And Lomb Inc | BEPREVE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 022288-001 | Sep 8, 2009 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Bausch And Lomb Inc | BEPREVE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 022288-001 | Sep 8, 2009 | AT | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 BEPREVE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb Inc | BEPREVE | bepotastine besilate | SOLUTION/DROPS;OPHTHALMIC | 022288-001 | Sep 8, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BEPREVE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2014169294 | Start Trial |
| Austria | 528003 | Start Trial |
| Japan | 2007145852 | Start Trial |
| Denmark | 0949260 | Start Trial |
| Indonesia | 21985 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
