BYSTOLIC Drug Patent Profile
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When do Bystolic patents expire, and when can generic versions of Bystolic launch?
Bystolic is a drug marketed by Allergan and is included in one NDA.
The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bystolic
A generic version of BYSTOLIC was approved as nebivolol hydrochloride by ANI PHARMS on April 16th, 2015.
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Questions you can ask:
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- What is Average Wholesale Price for BYSTOLIC?
Summary for BYSTOLIC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 31 |
| Patent Applications: | 3,603 |
| Drug Prices: | Drug price information for BYSTOLIC |
| Drug Sales Revenues: | Drug sales revenues for BYSTOLIC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BYSTOLIC |
| What excipients (inactive ingredients) are in BYSTOLIC? | BYSTOLIC excipients list |
| DailyMed Link: | BYSTOLIC at DailyMed |
Recent Clinical Trials for BYSTOLIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 4 |
| Martin M. Miner, MD | Phase 4 |
| State University of New York at Buffalo | Phase 3 |
Pharmacology for BYSTOLIC
| Drug Class | beta-Adrenergic Blocker |
| Mechanism of Action | Adrenergic beta-Antagonists |
Paragraph IV (Patent) Challenges for BYSTOLIC
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BYSTOLIC | Tablets | nebivolol hydrochloride | 2.5 mg, 5 mg, 10 mg, and 20 mg | 021742 | 7 | 2011-12-19 |
US Patents and Regulatory Information for BYSTOLIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 BYSTOLIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BYSTOLIC
See the table below for patents covering BYSTOLIC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 290844 | Farmaceutická kompozice a mikromletá forma hydrochloridu nebivololu (Pharmaceutical composition and micronized form of nebivolol hydrochloride) | ⤷ Sign Up |
| South Africa | 8902179 | ⤷ Sign Up | |
| Austria | 82498 | ⤷ Sign Up | |
| South Africa | 9501294 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYSTOLIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0334429 | C950031 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018 |
| 0334429 | 97C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 0334429 | SPC/GB96/048 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 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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