LYRICA CR Drug Patent Profile
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When do Lyrica Cr patents expire, and when can generic versions of Lyrica Cr launch?
Lyrica Cr is a drug marketed by Upjohn and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-seven patent family members in thirty-three countries.
The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lyrica Cr
A generic version of LYRICA CR was approved as pregabalin by ALEMBIC on July 19th, 2019.
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Summary for LYRICA CR
| International Patents: | 37 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 102 |
| Clinical Trials: | 161 |
| Patent Applications: | 4,098 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LYRICA CR |
| What excipients (inactive ingredients) are in LYRICA CR? | LYRICA CR excipients list |
| DailyMed Link: | LYRICA CR at DailyMed |
Recent Clinical Trials for LYRICA CR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 4 |
| Henry Ford Health System | Phase 4 |
| An-Najah National University | Phase 2/Phase 3 |
Paragraph IV (Patent) Challenges for LYRICA CR
| 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 |
US Patents and Regulatory Information for LYRICA CR
LYRICA CR is protected by three US patents.
Patents protecting LYRICA CR
Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-002 | Oct 11, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for LYRICA CR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Zentiva k.s. | Pregabalin Zentiva k.s. | pregabalin | EMEA/H/C/004277 Neuropathic painPregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderPregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults. |
Withdrawn | yes | no | no | 2017-02-27 | |
| Zentiva, k.s. | Pregabalin Zentiva | pregabalin | EMEA/H/C/003900 Neuropathic pain, , , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults., , , Epilepsy, , , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation., , , Generalised anxiety disorder, , , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults., , |
Authorised | yes | no | no | 2015-07-17 | |
| Mylan S.A.S. | Pregabalin Mylan Pharma | pregabalin | EMEA/H/C/003962 EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. |
Withdrawn | yes | no | no | 2015-06-25 | |
| Upjohn EESV | Pregabalin Pfizer | pregabalin | EMEA/H/C/003880 Neuropathic painPregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. |
Authorised | no | no | no | 2014-04-10 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for LYRICA CR
When does loss-of-exclusivity occur for LYRICA CR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8175
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 06310217
Patent: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0618211
Patent: composição farmacêutica contendo pregabalina e uso do referido composto
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 28200
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSINGCONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1330907
Patent: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 50
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 15009
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 45186
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 006000241
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 088422
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2377
Patent: ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷ Sign Up
Patent: 0800931
Patent: ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 45186
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES ORALES ADAPTEES A UNE SEULE PRISE PAR JOUR, CONTENANT LA PREGABALINE, UN AGENT MATRICIEL AINSI QU'UN AGENT GONFLANT (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 0600474
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 26394
Patent: SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0827
Patent: PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 34610
Estimated Expiration: ⤷ Sign Up
Patent: 09514847
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 482
Patent: ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 135
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 00281
Patent: Vaste farmaceutische samenstellingen die pregabaline bevatten.
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 7414
Patent: Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 081816
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 070693
Patent: COMPOSICIONES FARMACEUTICAS SOLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 45186
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 45186
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 080181
Patent: ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 45186
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0803115
Patent: Solid pharmaceutical compositions containing pregabalin
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1012533
Estimated Expiration: ⤷ Sign Up
Patent: 080059427
Patent: SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 49231
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 30080
Estimated Expiration: ⤷ Sign Up
Patent: 0803831
Patent: Solid pharmaceutical compositions containing pregabalin
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 08194
Patent: COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 890
Patent: COMPOSICIONES FARMACÉUTICAS SÓLIDAS QUE CONTIENEN PREGABALINA
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering LYRICA CR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 286106 | Analogy GABA a L-glutamové kyseliny (Derivatives of gamma-aminobutyric acid, process and intermediates for their preparation, their use and pharmaceutical preparation in which they are comprised) | ⤷ Sign Up |
| Australia | 2006310217 | Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent | ⤷ Sign Up |
| Austria | 241351 | ⤷ Sign Up | |
| New Zealand | 567414 | Solid oral pharmaceutical compositions for once daily dosing containing pregabalin, a matrix forming agent and a swelling agent | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA CR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0641330 | 300164 | Netherlands | ⤷ Sign Up | 300164, 20130518, EXPIRES: 20180517 |
| 0934061 | PA2004017 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS) |
| 0641330 | C300164 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 |
| 0641330 | SPC016/2004 | Ireland | ⤷ Sign Up | SPC016/2004: 20050803, EXPIRES: 20180517 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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