VARENICLINE TARTRATE - Generic Drug Details
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What are the generic 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, Avalanche Pharm, Endo Operations, Hetero Labs Ltd Iii, Leading Pharma, Lupin Ltd, Mankind Pharma, Mylan, Slate Run Pharma, and Zydus, and is included in fourteen 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 thirty-eight patent family members in nineteen countries.
There are eleven drug master file entries for varenicline tartrate. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for VARENICLINE TARTRATE
International Patents: | 38 |
US Patents: | 10 |
Tradenames: | 3 |
Applicants: | 14 |
NDAs: | 14 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 38 |
Patent Applications: | 305 |
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 |
⤷ Sign Up | ⤷ Sign Up | EQ 1MG BASE | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 216723-001 | Jun 12, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 201962-001 | Jan 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alkem Labs Ltd | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 214557-002 | Aug 23, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 201962-002 | Jan 25, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Avalanche Pharm | VARENICLINE TARTRATE | varenicline tartrate | TABLET;ORAL | 217283-001 | Mar 6, 2024 | AB | RX | No | 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 |
International Patents for VARENICLINE TARTRATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 7257371 | ⤷ Sign Up | |
Eurasian Patent Organization | 035335 | СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ РАССТРОЙСТВ С ПРИМЕНЕНИЕМ ВАРЕНИКЛИНА (METHODS OF TREATING OCULAR DISORDERS USING VARENICLINE) | ⤷ Sign Up |
Denmark | 3848028 | ⤷ Sign Up | |
Eurasian Patent Organization | 201790893 | СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ РАССТРОЙСТВ | ⤷ Sign Up |
European Patent Office | 3209295 | MÉTHODES DE TRAITEMENT DE TROUBLES OCULAIRES (METHODS OF TREATING OCULAR CONDITIONS) | ⤷ Sign Up |
>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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |
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