interaction records 54 assistance programs 55 0 personal data stored
OmniRx › Tools › Generic competition check › Varenicline Tartrate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Varenicline Tartrate, and who makes it?

Varenicline Tartrate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 15.3 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Varenicline Tartrate2 dosage-form groups in the Orange Book
19generic makers listed
  1. Varenicline Tartrate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came 15.3 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Chantix. 19 generic makers with 40 generic products listed as marketed; the first generic approval is dated 11 August 2021.

200520102015202020252030019brand 2006Ph Health Ltd, first approval 11 August 2021Apotex Inc, first approval 25 January 2023Zydus Worldwide Dmcc, first approval 12 June 2023Pharmazone, first approval 25 July 2023Mankind Pharma Ltd, first approval 1 August 2023Alkem Laboratories Ltd, first approval 23 August 2023Hetero Labs Ltd Unit Iii, first approval 23 October 2023Lupin Ltd, first approval 4 December 2023Ne Rx Pharma Llc, first approval 6 March 2024Ajanta Pharma Ltd, first approval 19 March 2024Dr Reddys Laboratories Ltd, first approval 1 October 2024Regcon Holdings Llc, first approval 29 October 2024Macleods Pharmaceuticals Ltd, first approval 9 December 2024Adaptis Pharma Private Ltd, first approval 8 April 2025Aurobindo Pharma Ltd, first approval 2 May 2025Viwit Pharmaceutical Co Ltd, first approval 6 May 2025Micro Labs Ltd, first approval 29 October 2025Umedica Laboratories Private Ltd, first approval 9 January 2026Somerset Therapeutics Llc, first approval 6 July 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Ph Health Ltd11 August 20212
Apotex Inc25 January 20232
Zydus Worldwide Dmcc12 June 20232
Pharmazone25 July 20234
Mankind Pharma Ltd1 August 20232
Alkem Laboratories Ltd23 August 20232
Hetero Labs Ltd Unit Iii23 October 20232
Lupin Ltd4 December 20232
Ne Rx Pharma Llc6 March 20242
Ajanta Pharma Ltd19 March 20242
Dr Reddys Laboratories Ltd1 October 20242
Regcon Holdings Llc29 October 20242

7 more makers are listed in the data.

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Spray, Nasal

Brand listed, no generic listed as marketed

Brand listed as marketed: Tyrvaya. No generic is listed as marketed.

202020252030203501brand 2021data datePatent 11224598 listed to expire 19 October 2035Patent 10456396 listed to expire 19 October 2035Patent 9597284 listed to expire 19 October 2035Patent 9532944 listed to expire 19 October 2035Patent 9504644 listed to expire 19 October 2035Patent 11911380 listed to expire 19 October 2035Patent 11903943 listed to expire 19 October 2035Patent 11903941 listed to expire 19 October 2035Patent 12576080 listed to expire 19 October 2035Patent 12653824 listed to expire 19 October 2035Patent 9504645 listed to expire 19 October 2035Patent 11903942 listed to expire 19 October 2035
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 19 October 2035Patent 11224598
  • 19 October 2035Patent 10456396 drug product
  • 19 October 2035Patent 9597284
  • 19 October 2035Patent 9532944
  • 19 October 2035Patent 9504644
  • 19 October 2035Patent 11911380
  • 19 October 2035Patent 11903943
  • 19 October 2035Patent 11903941

4 more patents are listed.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.