BYSTOLIC Drug Patent Profile
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Which patents cover Bystolic, and what generic alternatives are available?
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 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.
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: | 3,914 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for BYSTOLIC
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 BYSTOLIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Canada | 1337432 | METHODE DE REDUCTION DE LA TENSION ARTERIELLE (METHOD OF LOWERING THE BLOOD PRESSURE) | ⤷ Try a Trial |
European Patent Office | 0334429 | AGENTS FOR LOWERING THE BLOOD PRESSURE | ⤷ Try a Trial |
Slovakia | 105896 | COMPOSITIONS CONTAINING MICRONIZED NEBIVOLOL | ⤷ Try a Trial |
Israel | 112659 | Pharmaceutical compositions containing nebivolol | ⤷ Try a Trial |
Cyprus | 2329 | Compositions containing micronized nebivolol. | ⤷ Try a Trial |
China | 1112921 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYSTOLIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0334429 | 97C0002 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
0334429 | SPC/GB96/048 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NEBIVOLOL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE; REGISTERED: NL RVG/19317 19951018; UK 00242/0309 19960509 |
0334429 | C950031 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NEVIVOLOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HYDRO - CHLORIDE; REGISTRATION NO/DATE: RVG 19317 19951018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |