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OmniRx › Tools › Generic competition check › Cetirizine Hydrochloride

Generic competition · all medicines · read 12 November 2026

Is there a generic of Cetirizine Hydrochloride, and who makes it?

Cetirizine Hydrochloride appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 29 generic makers listed as marketed across them. 2 groups have 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 between 0.1 and 11.5 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.
Cetirizine Hydrochloride7 dosage-form groups in the Orange Book
29generic makers listed
  1. Cetirizine Hydrochloride appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 29 generic makers listed as marketed across them.
  2. 2 groups have 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 between 0.1 and 11.5 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: Zyrtec Allergy. 14 generic makers with 42 generic products listed as marketed; the first generic approval is dated 27 December 2007.

200520102015202020252030014brand 2007Apotex Inc, first approval 27 December 2007Contract Pharmacal Corp, first approval 27 December 2007Mylan Pharmaceuticals Inc, first approval 27 December 2007Perrigo R And D Co, first approval 27 December 2007Pld Acquisitions Llc Dba Avema Pharma Solutions, first approval 27 December 2007Sun Pharmaceutical Industries Ltd, first approval 27 December 2007Glenmark Pharmaceuticals Inc Usa, first approval 28 December 2007Dr Reddys Laboratories Ltd, first approval 15 January 2008Orbion Pharmaceuticals Private Ltd, first approval 19 February 2009Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd, first approval 26 August 2009Pharmazone, first approval 15 June 2010Aurobindo Pharma Ltd, first approval 5 August 2015Granules India Ltd, first approval 22 December 2017Regcon Holdings Llc, first approval 3 October 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Apotex Inc27 December 20072
Contract Pharmacal Corp27 December 20072
Mylan Pharmaceuticals Inc27 December 20074
Perrigo R And D Co27 December 20074
Pld Acquisitions Llc Dba Avema Pharma Solutions27 December 20072
Sun Pharmaceutical Industries Ltd27 December 20074
Glenmark Pharmaceuticals Inc Usa28 December 20072
Dr Reddys Laboratories Ltd15 January 20084
Orbion Pharmaceuticals Private Ltd19 February 20094
Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd26 August 20094
Pharmazone15 June 20104
Aurobindo Pharma Ltd5 August 20154

2 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.

Solution, Oral

Four or more generic makers listed

Brand listed as marketed: Children's Zyrtec Allergy and Children's Zyrtec Hives. 13 generic makers with 28 generic products listed as marketed; the first generic approval is dated 9 April 2008.

19952000200520102015202020252030013brand 1996Perrigo R And D Co, first approval 9 April 2008Taro Pharmaceutical Industries Ltd, first approval 22 April 2008Padagis Us Llc, first approval 17 June 2008Pharmaceutical Associates Inc, first approval 18 June 2008Bionpharma Inc, first approval 6 October 2008Pharmazone, first approval 30 March 2009Amneal Pharmaceuticals, first approval 7 October 2009Bajaj Medical Llc, first approval 12 November 2009Aurobindo Pharma Ltd, first approval 2 February 2010Chartwell Molecular Holdings Llc, first approval 22 April 2011Hetero Labs Ltd Unit Iii, first approval 13 March 2019Quagen Pharmaceuticals Llc, first approval 16 May 2019Rubicon Research Ltd, first approval 25 February 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Perrigo R And D Co9 April 20083
Taro Pharmaceutical Industries Ltd22 April 20085
Padagis Us Llc17 June 20081
Pharmaceutical Associates Inc18 June 20081
Bionpharma Inc6 October 20081
Pharmazone30 March 20093
Amneal Pharmaceuticals7 October 20093
Bajaj Medical Llc12 November 20093
Aurobindo Pharma Ltd2 February 20102
Chartwell Molecular Holdings Llc22 April 20113
Hetero Labs Ltd Unit Iii13 March 20191
Quagen Pharmaceuticals Llc16 May 20191

1 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.

Tablet, Chewable, Oral

One to three generic makers listed

Brand listed as marketed: Children's Zyrtec Allergy. 3 generic makers with 8 generic products listed as marketed; the first generic approval is dated 11 January 2008.

20052010201520202025203003brand 2007Sandoz Inc, first approval 14 February 2008Jubilant Generics Ltd, first approval 19 February 2015Novel Laboratories Inc, first approval 8 March 2016data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc14 February 20082
Jubilant Generics Ltd19 February 20154
Novel Laboratories Inc8 March 20162

Patents and exclusivities still listed

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

Capsule, Oral

One to three generic makers listed

Brand listed as marketed: Cetirizine Hydrochloride Allergy and Cetirizine Hydrochloride Hives Relief. 3 generic makers with 4 generic products listed as marketed; the first generic approval is dated 12 August 2016.

20052010201520202025203003brand 2009Onesource Softgels Pte Ltd, first approval 21 July 2017Aurobindo Pharma Ltd, first approval 20 July 2018Catalent Pharma Solutions Llc, first approval 21 September 2020data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Onesource Softgels Pte Ltd21 July 20171
Aurobindo Pharma Ltd20 July 20182
Catalent Pharma Solutions Llc21 September 20201

Patents and exclusivities still listed

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

Tablet, Orally Disintegrating, Oral

One to three generic makers listed

Brand listed as marketed: Zyrtec Allergy. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 2 September 2015.

2010201520202025203002brand 2010Perrigo R And D Co, first approval 2 September 2015Aurobindo Pharma Ltd, first approval 11 September 2020data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Perrigo R And D Co2 September 20151
Aurobindo Pharma Ltd11 September 20201

Patents and exclusivities still listed

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

Solution/Drops, Ophthalmic

Brand listed, no generic listed as marketed

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

2015202020252030203501brand 2017data datePatent 9993471 listed to expire 15 March 2030Patent 8829005 listed to expire 15 March 2030Patent 9750684 listed to expire 15 March 2030Patent 8829005*PED listed to expire 15 September 2030Patent 9254286 listed to expire 9 July 2032Patent 9254286*PED listed to expire 9 January 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 March 2030Patent 9993471
  • 15 March 2030Patent 8829005
  • 15 March 2030Patent 9750684 drug product
  • 15 September 2030Patent 8829005*PED
  • 9 July 2032Patent 9254286 drug product
  • 9 January 2033Patent 9254286*PED

Solution, Intravenous

Brand listed, no generic listed as marketed

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

201520202025203001brand 2019data datePatent 9180090 listed to expire 11 February 2030Patent 8513259 listed to expire 11 February 2030Patent 9119771 listed to expire 11 February 2030Patent 8314083 listed to expire 28 February 2030Patent 8263581 listed to expire 28 February 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 11 February 2030Patent 9180090
  • 11 February 2030Patent 8513259
  • 11 February 2030Patent 9119771
  • 28 February 2030Patent 8314083
  • 28 February 2030Patent 8263581

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.