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Last Updated: May 28, 2022

Pregabalin - Generic Drug Details


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What are the generic drug sources for pregabalin and what is the scope of freedom to operate?

Pregabalin is the generic ingredient in three branded drugs marketed by Upjohn, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Allied, Amneal Pharms Co, Apotex, Celltrion, Changzhou Pharm, Cipla, Dr Reddys, Eskayef, Hetero Labs Ltd Iii, Hikal, Invagen Pharms, MSN, Mylan, Rising, Sciegen Pharms Inc, Shuangcheng, Sun Pharm, Teva Pharms, Invatech, Alvogen, and Rubicon, and is included in thirty-six NDAs. There are three patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pregabalin has thirty-seven patent family members in thirty-three countries.

There are forty-one drug master file entries for pregabalin. Thirty-seven suppliers are listed for this compound. There are twelve tentative approvals for this compound.

Drug Prices for pregabalin

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Drug Sales Revenue Trends for pregabalin

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Recent Clinical Trials for pregabalin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Aga Khan UniversityEarly Phase 1
Laboratorios Silanes S.A. de C.V.Phase 3
Al-Kindy College of MedicinePhase 4

See all pregabalin clinical trials

Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing225MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing200MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing150MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for pregabalin
Anatomical Therapeutic Chemical (ATC) Classes for pregabalin
Paragraph IV (Patent) Challenges for PREGABALIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LYRICA CR Extended-release Tablets pregabalin 82.5 mg and 165 mg 209501 1 2018-02-02
LYRICA CR Extended-release Tablets pregabalin 330 mg 209501 1 2018-01-29
LYRICA Oral Solution pregabalin 20 mg/mL 022488 2010-05-19
LYRICA Capsules pregabalin 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg 021446 2008-12-30

US Patents and Regulatory Information for pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys PREGABALIN pregabalin CAPSULE;ORAL 209664-003 Jul 19, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msn PREGABALIN pregabalin TABLET, EXTENDED RELEASE;ORAL 213226-003 Apr 13, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hetero Labs Ltd Iii PREGABALIN pregabalin CAPSULE;ORAL 206912-003 Oct 8, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alvogen PREGABALIN pregabalin TABLET, EXTENDED RELEASE;ORAL 211687-002 Jul 6, 2021 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 See Plans and Pricing See Plans and Pricing
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004 See Plans and Pricing See Plans and Pricing
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 See Plans and Pricing See Plans and Pricing
Upjohn LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for pregabalin

Country Patent Number Title Estimated Expiration
Cyprus 1115009 See Plans and Pricing
Eurasian Patent Organization 200800931 ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ See Plans and Pricing
Poland 1945186 See Plans and Pricing
Hong Kong 1126394 SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pregabalin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0934061 PA2004017 Lithuania See Plans and Pricing PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330 C300164 Netherlands See Plans and Pricing PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0934061 PA2004017,C0934061 Lithuania See Plans and Pricing PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330 CR 2004 00036 Denmark See Plans and Pricing PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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