Varenicline tartrate - Generic Drug Details
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What are the generic drug sources for varenicline tartrate and what is the scope of freedom to operate?
Varenicline tartrate
is the generic ingredient in three branded drugs marketed by Oyster Point Pharma, Pf Prism Cv, Ajanta Pharma Ltd, Alkem Labs Ltd, Apotex, Dr Reddys, Endo Operations, Hetero Labs Ltd Iii, Indoco, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Medley Pharms, Mylan, Ne Rx Pharma, Piramal, and Zydus, and is included in seventeen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Varenicline tartrate has forty-one patent family members in twenty countries.
There are eleven drug master file entries for varenicline tartrate. Twenty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for varenicline tartrate
International Patents: | 41 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 17 |
NDAs: | 17 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 28 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 38 |
Patent Applications: | 307 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for varenicline tartrate |
What excipients (inactive ingredients) are in varenicline tartrate? | varenicline tartrate excipients list |
DailyMed Link: | varenicline tartrate at DailyMed |
Recent Clinical Trials for varenicline tartrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yale University | Phase 2 |
CTC Bio, Inc. | Phase 1 |
University of Kansas Medical Center | Phase 3 |
Generic filers with tentative approvals for VARENICLINE TARTRATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | EQ 1MG BASE | TABLET;ORAL |
⤷ Try for Free | ⤷ Try for Free | EQ 0.5MG BASE | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for varenicline tartrate
Drug Class | Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist |
Mechanism of Action | Cholinergic Agonists Partial Cholinergic Nicotinic Agonists |
Medical Subject Heading (MeSH) Categories for varenicline tartrate
Anatomical Therapeutic Chemical (ATC) Classes for varenicline tartrate
Paragraph IV (Patent) Challenges for VARENICLINE TARTRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TYRVAYA | Nasal Spray | varenicline tartrate | 0.03 mg/spray | 213978 | 1 | 2023-04-21 |
CHANTIX | Tablets | varenicline tartrate | 0.5 mg and 1 mg | 021928 | 5 | 2010-05-10 |
US Patents and Regulatory Information for varenicline tartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ajanta Pharma Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 213019-002 | Mar 19, 2024 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Oyster Point Pharma | TYRVAYA | varenicline tartrate | SPRAY;NASAL | 213978-001 | Oct 15, 2021 | RX | Yes | Yes | 11,911,380 | ⤷ Try for Free | ⤷ Try for Free | ||||
Oyster Point Pharma | TYRVAYA | varenicline tartrate | SPRAY;NASAL | 213978-001 | Oct 15, 2021 | RX | Yes | Yes | 10,456,396 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for varenicline tartrate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 3209295 | ⤷ Try for Free | |
Malaysia | 186870 | ⤷ Try for Free | |
Mexico | 2022005888 | METODOS PARA TRATAR AFECCIONES OCULARES. (METHODS OF TREATING OCULAR CONDITIONS.) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for varenicline tartrate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1044189 | SPC/GB08/034 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928 |
1044189 | 08C0039 | France | ⤷ Try for Free | PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Varenicline Tartrate
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