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OmniRx › Tools › Generic competition check › Methylphenidate Hydrochloride

Generic competition · all medicines · read 12 November 2026

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

Methylphenidate Hydrochloride appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 28 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 between 5.6 and 11.9 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.
Methylphenidate Hydrochloride7 dosage-form groups in the Orange Book
28generic makers listed
  1. Methylphenidate Hydrochloride appears in 7 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 28 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 between 5.6 and 11.9 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, Extended Release, Oral

Four or more generic makers listed

Brand listed as marketed: Concerta and Relexxii. 11 generic makers with 42 generic products listed as marketed; the first generic approval is dated 1 June 1988.

1980198519901995200020052010201520202025203020352040011brand 1982Specgx Llc, first approval 9 May 2000Lannett Co Inc, first approval 9 July 2013Abhai Llc, first approval 9 June 2015Aurolife Pharma Llc, first approval 21 October 2016Osmotica Pharmaceutical Us Llc, first approval 28 July 2017Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc, first approval 21 March 2018Granules Pharmaceuticals Inc, first approval 21 November 2018Andor Pharmaceuticals Llc, first approval 24 April 2019Ascent Pharmaceuticals Inc, first approval 3 September 2019Alkem Laboratories Ltd, first approval 6 October 2020Sun Pharmaceutical Industries Inc, first approval 25 August 2023data datePatent 10695336 listed to expire 3 February 2037Patent 10265308 listed to expire 3 February 2037Patent 9855258 listed to expire 3 February 2037Patent 9827234 listed to expire 3 February 2037Patent 9707217 listed to expire 3 February 2037
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Specgx Llc9 May 20002
Lannett Co Inc9 July 20134
Abhai Llc9 June 20152
Aurolife Pharma Llc21 October 20164
Osmotica Pharmaceutical Us Llc28 July 20175
Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc21 March 20185
Granules Pharmaceuticals Inc21 November 20186
Andor Pharmaceuticals Llc24 April 20194
Ascent Pharmaceuticals Inc3 September 20194
Alkem Laboratories Ltd6 October 20205
Sun Pharmaceutical Industries Inc25 August 20231

Patents and exclusivities still listed

  • 3 February 2037Patent 10695336
  • 3 February 2037Patent 10265308 drug product
  • 3 February 2037Patent 9855258 drug product
  • 3 February 2037Patent 9827234
  • 3 February 2037Patent 9707217 drug product

Capsule, Extended Release, Oral

Four or more generic makers listed

Brand listed as marketed: Aptensio Xr, Jornay Pm, Metadate Cd and Ritalin La. 6 generic makers with 32 generic products listed as marketed; the first generic approval is dated 1 December 2011.

2000200520102015202020252030203506brand 2001Dr Reddys Laboratories Sa, first approval 1 December 2011Teva Pharmaceuticals Usa, first approval 19 July 2012Specgx Llc, first approval 29 September 2015Impax Laboratories Inc, first approval 28 July 2016Actavis Elizabeth Llc, first approval 13 December 2018Granules Pharmaceuticals Inc, first approval 23 May 2019data datePatent 10292937 listed to expire 23 March 2032Patent 9603809 listed to expire 23 March 2032Patent 8916588 listed to expire 23 March 2032Patent 9028868 listed to expire 23 March 2032Patent 10617651 listed to expire 23 March 2032Patent 9034902 listed to expire 23 March 2032Patent 10881618 listed to expire 23 March 2032Patent 11911518 listed to expire 23 March 2032Patent 11241391 listed to expire 23 March 2032Patent 11241392 listed to expire 23 March 2032Patent 9498447 listed to expire 23 March 2032Patent 9283214 listed to expire 23 March 2032Patent 9023389 listed to expire 23 March 2032Patent 10905652 listed to expire 23 March 2032Patent 8927010 listed to expire 23 March 2032Patent 10182995 listed to expire 23 March 2032
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Dr Reddys Laboratories Sa1 December 20115
Teva Pharmaceuticals Usa19 July 20123
Specgx Llc29 September 20156
Impax Laboratories Inc28 July 20166
Actavis Elizabeth Llc13 December 20187
Granules Pharmaceuticals Inc23 May 20195

Patents and exclusivities still listed

  • 23 March 2032Patent 10292937
  • 23 March 2032Patent 9603809
  • 23 March 2032Patent 8916588
  • 23 March 2032Patent 9028868
  • 23 March 2032Patent 10617651
  • 23 March 2032Patent 9034902
  • 23 March 2032Patent 10881618
  • 23 March 2032Patent 11911518

8 more patents are listed.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Ritalin. 12 generic makers with 36 generic products listed as marketed; the first generic approval is dated 29 August 1997.

19952000200520102015202020252030012Specgx Llc, first approval 27 November 1998Sun Pharmaceutical Industries Inc, first approval 15 March 2012Oxford Pharmaceuticals Llc, first approval 23 September 2014Ascent Pharmaceuticals Inc, first approval 22 September 2015Novel Laboratories Inc, first approval 13 November 2015Mpp Pharma Llc, first approval 3 March 2017Abhai Llc, first approval 11 May 2017Bionpharma Inc, first approval 2 March 2018Cediprof Inc, first approval 1 February 2019Alkem Laboratories Ltd, first approval 4 October 2019Prinston Pharmaceutical Inc, first approval 23 July 2020Accord Healthcare Inc, first approval 28 October 2020data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Specgx Llc27 November 19983
Sun Pharmaceutical Industries Inc15 March 20123
Oxford Pharmaceuticals Llc23 September 20143
Ascent Pharmaceuticals Inc22 September 20153
Novel Laboratories Inc13 November 20153
Mpp Pharma Llc3 March 20173
Abhai Llc11 May 20173
Bionpharma Inc2 March 20183
Cediprof Inc1 February 20193
Alkem Laboratories Ltd4 October 20193
Prinston Pharmaceutical Inc23 July 20203
Accord Healthcare Inc28 October 20203

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: Methylin. 8 generic makers with 16 generic products listed as marketed; the first generic approval is dated 23 July 2010.

200020052010201520202025203008brand 2002Tris Pharma Inc, first approval 23 July 2010Novel Laboratories Inc, first approval 14 August 2015Abhai Llc, first approval 18 November 2016Adaptis Pharma Private Ltd, first approval 3 October 2018Alkem Laboratories Ltd, first approval 30 March 2020Anda Repository Llc, first approval 10 April 2020Quagen Pharmaceuticals Llc, first approval 4 June 2020Ascent Pharmaceuticals Inc, first approval 29 January 2021data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Tris Pharma Inc23 July 20102
Novel Laboratories Inc14 August 20152
Abhai Llc18 November 20162
Adaptis Pharma Private Ltd3 October 20182
Alkem Laboratories Ltd30 March 20202
Anda Repository Llc10 April 20202
Quagen Pharmaceuticals Llc4 June 20202
Ascent Pharmaceuticals Inc29 January 20212

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

Every brand product here is listed as discontinued. 2 generic makers with 6 generic products listed as marketed; the first generic approval is dated 25 February 2015.

200020052010201520202025203002brand 2003Rising Pharma Holdings Inc, first approval 7 November 2016Ascent Pharmaceuticals Inc, first approval 29 December 2017data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Rising Pharma Holdings Inc7 November 20163
Ascent Pharmaceuticals Inc29 December 20173

Patents and exclusivities still listed

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

Tablet, Extended Release, Chewable, Oral

Brand listed, no generic listed as marketed

Brand listed as marketed: Quillichew Er. No generic is listed as marketed.

2015202020252030203501brand 2015data datePatent 8202537 listed to expire 15 March 2027Patent 8287903 listed to expire 15 February 2031Patent 9295642 listed to expire 14 August 2033Patent 11103495 listed to expire 14 August 2033Patent 9545399 listed to expire 14 August 2033Patent 9844544 listed to expire 14 August 2033Patent 10857143 listed to expire 14 August 2033Patent 11103494 listed to expire 14 August 2033Patent 8999386 listed to expire 14 August 2033Patent 11633389 listed to expire 14 August 2033
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 March 2027Patent 8202537 drug product
  • 15 February 2031Patent 8287903 drug product
  • 14 August 2033Patent 9295642 drug product
  • 14 August 2033Patent 11103495 drug product
  • 14 August 2033Patent 9545399 drug product
  • 14 August 2033Patent 9844544 drug product
  • 14 August 2033Patent 10857143 drug product
  • 14 August 2033Patent 11103494 drug product

2 more patents are listed.

For Suspension, Extended Release, Oral

One to three generic makers listed

Brand listed as marketed: Quillivant Xr. 1 generic maker with 1 generic product listed as marketed; the first generic approval is dated 17 May 2018.

20102015202020252030203501brand 2012Actavis Laboratories Fl Inc, first approval 17 May 2018data datePatent 8062667 listed to expire 29 March 2029Patent 8465765 listed to expire 15 February 2031Patent 8778390 listed to expire 15 February 2031Patent 8956649 listed to expire 15 February 2031Patent 8563033 listed to expire 15 February 2031Patent 9040083 listed to expire 15 February 2031Patent 8287903 listed to expire 15 February 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Laboratories Fl Inc17 May 20181

Patents and exclusivities still listed

  • 29 March 2029Patent 8062667 drug product
  • 15 February 2031Patent 8465765 drug product
  • 15 February 2031Patent 8778390 drug product
  • 15 February 2031Patent 8956649 drug product
  • 15 February 2031Patent 8563033 drug product
  • 15 February 2031Patent 9040083 drug product
  • 15 February 2031Patent 8287903 drug product

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.