Manages neuropathic pain associated with diabetic peripheral neuropathy. Sold as Lyrica, Lyrica Cr. Every FDA application for this active ingredient: 5 branded and 58 generic.
As of Nov 13, 2026, FDA lists 63 applications for Pregabalin (sold as Lyrica, Lyrica Cr), first approved Dec 30, 2004, with 9 new uses approved and 0 published complete response letters.
| Pregabalin | Part D | $191M | -4% | 1,662,602 |
| Lyrica | Part D | $52.7M | -15% | 9,931 |
| Pregabalin ER | Part D | $1.8M | +18% | 1,347 |
| Lyrica Cr | Part D | $191K | -39% | 47 |
| Prolonged Multimodal Analgesia for Postsurgical PainAcute and Chronic Postsurgical Pain · Beijing Tiantan Hospital | Not applicable | Not yet recruiting | Nov 13, 2026 |
| Efficacy and Safety of Kabalin Cap.(Pregabalin) in Patients With Neuropathic PainPeripheral or Central Neuropathic Pain · HK inno.N Corporation | — | Recruiting | Nov 12, 2026 |
| Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot StudyChronic Postsurgical Pain, Chronic Post Cancer Surgery Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre | Phase 2 | Recruiting | Nov 5, 2026 |
| Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot StudyCancer Pain, Orofacial Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre | Phase 2 | Recruiting | Nov 5, 2026 |
| A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT) · Tavo Biotherapeutics | Phase 2 | Recruiting | Nov 3, 2026 |
| Comparison of Two Postoperative Care Strategies After Breast SurgeryPostoperative Pain, Pain Management · Moumtzidou Maria Aikaterini | Not applicable | Recruiting | Oct 19, 2026 |
| Acute Post-Amputation Pain Management After Combat-Related Lower Limb InjuryPostamputation Pain, Lower Limb Amputation · Kharkiv National Medical University | Not applicable | Not yet recruiting | Oct 7, 2026 |
| Pregabalin for Chronic Pelvic Pain in WomenChronic Pelvic Pain, Chronic Pelvic Pain Syndrome · Beijing Tiantan Hospital | Not applicable | Not yet recruiting | Sep 14, 2026 |
| Dec 30, 2004 | LyricaNDA 21446 · New molecular entity | Upjohn | 22 | Marketed |
| Dec 30, 2004 | LyricaNDA 21723 · TYPE 6 | Cp Pharms | 0 | Marketed |
| Jun 10, 2005 | LyricaNDA 21724 · TYPE 6 | Cp Pharms | 0 | Marketed |
| Jan 4, 2010 | LyricaNDA 22488 · New dosage form | Upjohn | 15 | Marketed |
| Oct 11, 2017 | Lyrica CrNDA 209501 · New formulation or manufacturer | Upjohn | 3 | Marketed |
| Jul 19, 2019 | PregabalinANDA 91219 | Teva Pharms | 0 | Discontinued |
| Jul 19, 2019 | PregabalinANDA 91224 | Teva Pharms | 0 | Discontinued |
| Jul 19, 2019 | PregabalinANDA 203459 | Alembic | 3 | Marketed |
| Jul 19, 2019 | PregabalinANDA 207623 | Alkem Labs Ltd | 2 | Marketed |
| Jul 19, 2019 | PregabalinANDA 207799 | Alkem Labs Ltd | 4 | Marketed |
| Jul 19, 2019 | PregabalinANDA 209357 | Msn | 3 | Marketed |
| Jul 19, 2019 | PregabalinANDA 209664 | Dr Reddys | 3 | Marketed |
| Jul 19, 2019 | PregabalinANDA 210432 | Rising | 3 | Marketed |
| Jul 19, 2019 | PregabalinANDA 211384 | Invagen Pharms | 3 | Marketed |
| Jul 19, 2019 | PregabalinANDA 208677 | Sciegen Pharms | 5 | Marketed |
| Jul 19, 2019 | PregabalinANDA 209743 | Amneal Pharms Co | 5 | Marketed |
| Sep 20, 2019 | PregabalinANDA 91228 | Pharmobedient | 0 | Discontinued |
| Sep 30, 2019 | PregabalinANDA 210891 | Pharmobedient | 0 | Marketed |
| Oct 8, 2019 | PregabalinANDA 206912 | Hetero Labs Ltd Iii | 2 | Marketed |
| Nov 29, 2019 | PregabalinANDA 91157 | Sun Pharm | 3 | Discontinued |
| Dec 26, 2019 | PregabalinANDA 210585 | Somerset Theraps LLC | 0 | Marketed |
| Jan 10, 2020 | PregabalinANDA 212280 | Cipla | 4 | Discontinued |
| Mar 20, 2020 | PregabalinANDA 212865 | Chartwell Rx | 2 | Marketed |
| Mar 23, 2020 | PregabalinANDA 213423 | Creekwood Pharms | 3 | Marketed |
| Jul 9, 2020 | PregabalinANDA 91025 | Actavis Elizabeth | 3 | Discontinued |
| Apr 13, 2021 | PregabalinANDA 211593 | Alvogen | 0 | Discontinued |
| Apr 13, 2021 | PregabalinANDA 211889 | Sun Pharm | 1 | Discontinued |
| Apr 13, 2021 | PregabalinANDA 211948 | Pharmobedient | 0 | Discontinued |
| Apr 13, 2021 | PregabalinANDA 213226 | Msn | 1 | Marketed |
| Apr 13, 2021 | PregabalinANDA 213313 | Apotex | 2 | Discontinued |
| Jul 2, 2021 | PregabalinANDA 211431 | Pharmobedient | 0 | Discontinued |
| Jul 6, 2021 | PregabalinANDA 211687 | Alvogen | 2 | Discontinued |
| Jul 7, 2021 | PregabalinANDA 211685 | Apotex | 2 | Discontinued |
| Jul 15, 2021 | PregabalinANDA 214322 | Tris Pharma Inc | 2 | Marketed |
| Nov 4, 2021 | PregabalinANDA 211967 | Pharmobedient | 0 | Discontinued |
| Feb 18, 2022 | PregabalinANDA 212604 | Anda Repository | 0 | Marketed |
| Mar 8, 2022 | PregabalinANDA 212988 | Pharmazone | 2 | Marketed |
| Mar 22, 2022 | PregabalinANDA 215249 | Rubicon Research | 2 | Marketed |
| May 3, 2022 | PregabalinANDA 91040 | Lupin Ltd | 2 | Discontinued |
| Jul 18, 2022 | PregabalinANDA 216197 | Pharmazone | 3 | Marketed |
| Aug 26, 2022 | PregabalinANDA 215577 | Zydus Pharms | 0 | Discontinued |
| Sep 1, 2022 | PregabalinANDA 207883 | Prinston | 2 | Marketed |
| Sep 14, 2022 | PregabalinANDA 215675 | Sciegen Pharms | 0 | Discontinued |
| Dec 9, 2022 | PregabalinANDA 206752 | Zydus Pharms | 1 | Discontinued |
| Mar 29, 2023 | PregabalinANDA 205321 | Aurobindo Pharma | 2 | Marketed |
| Apr 26, 2023 | PregabalinANDA 215755 | Strides Pharma | 2 | Discontinued |
| Jun 1, 2023 | PregabalinANDA 214496 | Epic Pharma LLC | 0 | Marketed |
| Jul 12, 2023 | PregabalinANDA 206452 | Cadila Pharms Ltd | 1 | Discontinued |
| Jan 24, 2024 | PregabalinANDA 209883 | Strides Pharma | 1 | Discontinued |
| May 17, 2024 | PregabalinANDA 208113 | Regcon Holdings | 1 | Marketed |
| Nov 12, 2024 | PregabalinANDA 205924 | Macleods Pharms | 1 | Discontinued |
| Jan 28, 2025 | PregabalinANDA 217857 | Aiping Pharm Inc | 0 | Marketed |
| Feb 21, 2025 | PregabalinANDA 91222 | Pharmobedient | 0 | Marketed |
| Feb 21, 2025 | PregabalinANDA 206942 | Torrent | 1 | Marketed |
| May 20, 2025 | PregabalinANDA 209530 | Jubilant Generics | 0 | Marketed |
| Feb 24, 2026 | PregabalinANDA 218529 | Caplin | 0 | Marketed |
| Apr 30, 2026 | PregabalinANDA 219593 | Unichem | 0 | Discontinued |
| — | PregabalinANDA 91221 | Watson Labs Inc | 0 | Discontinued |
| — | PregabalinANDA 91229 | Sandoz Inc | 0 | Discontinued |
| — | PregabalinANDA 201989 | Lupin Ltd | 0 | Discontinued |
| — | PregabalinANDA 202269 | Novel Labs Inc | 0 | Discontinued |
| — | PregabalinANDA 202998 | Apotex Inc | 0 | Discontinued |
| — | PregabalinANDA 203022 | Apotex Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Alembic
Cipla
Apotex
Zydus Pharms
Aurobindo Pharma
Strides Pharma