DrugPatentWatch Database Preview
Tapentadol hydrochloride - Generic Drug Details
» See Plans and Pricing
What are the generic drug sources for tapentadol hydrochloride and what is the scope of patent protection?
Tapentadol hydrochloride
is the generic ingredient in two branded drugs marketed by Collegium Pharm Inc and is included in three NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Tapentadol hydrochloride has two hundred and seventy-seven patent family members in thirty-seven countries.
There are five drug master file entries for tapentadol hydrochloride. There are two tentative approvals for this compound.
Summary for tapentadol hydrochloride
| International Patents: | 277 |
| US Patents: | 7 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 5 |
| Bulk Api Vendors: | 34 |
| Clinical Trials: | 66 |
| Patent Applications: | 283 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tapentadol hydrochloride |
| DailyMed Link: | tapentadol hydrochloride at DailyMed |
Recent Clinical Trials for tapentadol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| All India Institute of Medical Sciences, Bhubaneswar | Phase 4 |
| All India Institute of Medical Sciences, Bhubaneswar | N/A |
| Oslo University Hospital | Phase 4 |
Generic filers with tentative approvals for TAPENTADOL HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 20MG BASE/ML | SOLUTION;ORAL |
| Start Trial | Start Trial | 75MG | TABLET;ORAL |
| Start Trial | Start Trial | 100MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Paragraph IV (Patent) Challenges for TAPENTADOL HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUCYNTA | SOLUTION;ORAL | tapentadol hydrochloride | 203794 | 2013-12-20 |
| NUCYNTA | TABLET;ORAL | tapentadol hydrochloride | 022304 | 2012-11-20 |
| NUCYNTA ER | TABLET, EXTENDED RELEASE;ORAL | tapentadol hydrochloride | 200533 | 2012-11-20 |
US Patents and Regulatory Information for tapentadol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >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 tapentadol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | Start Trial | Start Trial |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for tapentadol hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 102004032051 | Start Trial |
| Poland | 1859789 | Start Trial |
| Ecuador | SP066345 | Start Trial |
| Ecuador | SP17046065 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for tapentadol hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0693475 | SPC/GB11/031 | United Kingdom | Start Trial | PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204 |
| 0693475 | CA 2010 00036 | Denmark | Start Trial | |
| 0693475 | 12C0016 | France | Start Trial | PRODUCT NAME: TAPENTADOL SOUS FORME DE SA BASE LIBRE OU SOUS FORME D'UN DE SES SELS D'ACIDES ACCEPTABLES DU POINT DE VUE PHYSIOLOGIQUE; NAT. REGISTRATION NO/DATE: NL40884 20111003; FIRST REGISTRATION: DE - 76261.00.00 20100819 |
| 0693475 | PA2011007 | Lithuania | Start Trial | PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
