DrugPatentWatch Database Preview
NORDITROPIN Drug Profile
Email this page to a colleague
See Plans and PricingWhen do Norditropin patents expire, and what generic alternatives are available?
Norditropin is a drug marketed by Novo Nordisk Inc and is included in two NDAs. There are twenty-two patents protecting this drug.
The generic ingredient in NORDITROPIN is somatropin. There are four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the somatropin profile page.
US ANDA Litigation and Generic Entry Outlook for Norditropin
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for NORDITROPIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 51 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NORDITROPIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NORDITROPIN |
| DailyMed Link: | NORDITROPIN at DailyMed |
Recent Clinical Trials for NORDITROPIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Center for Human Reproduction | Phase 1/Phase 2 |
| Oregon Health and Science University | N/A |
| University of Aarhus | N/A |
Recent Litigation for NORDITROPIN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| SMITH v. NOVO NORDISK INC. | 2016-08-08 |
| Illinois Tool Works Inc. v. Frito-Lay North America Inc. | 2006-01-27 |
| Merck & Co. Inc. v. Dr. Reddy&039s Lab. Ltd | 2004-09-29 |
Pharmacology for NORDITROPIN
| Drug Class | Recombinant Human Growth Hormone |
US Patents and Regulatory Information for NORDITROPIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin | INJECTABLE;INJECTION | 021148-011 | Jan 23, 2015 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin | INJECTABLE;INJECTION | 021148-009 | Mar 1, 2010 | BX | RX | No | No | Start Trial | Start Trial | Y | Start Trial | ||
| Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin | INJECTABLE;INJECTION | 021148-009 | Mar 1, 2010 | BX | RX | No | No | Start Trial | Start Trial | Y | Start Trial | ||
| Novo Nordisk Inc | NORDITROPIN NORDIFLEX | somatropin | INJECTABLE;INJECTION | 021148-006 | Oct 1, 2004 | DISCN | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin | INJECTABLE;INJECTION | 021148-010 | Mar 1, 2010 | RX | No | No | Start Trial | Start Trial | Y | Start Trial | |||
| Novo Nordisk Inc | NORDITROPIN FLEXPRO | somatropin | INJECTABLE;INJECTION | 021148-011 | Jan 23, 2015 | RX | No | 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 NORDITROPIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc | NORDITROPIN | somatropin | INJECTABLE;INJECTION | 021148-002 | Jun 20, 2000 | Start Trial | Start Trial |
| Novo Nordisk Inc | NORDITROPIN | somatropin recombinant | INJECTABLE;INJECTION | 019721-001 | May 8, 1995 | Start Trial | Start Trial |
| Novo Nordisk Inc | NORDITROPIN | somatropin | INJECTABLE;INJECTION | 021148-001 | Jun 20, 2000 | Start Trial | Start Trial |
| Novo Nordisk Inc | NORDITROPIN | somatropin | INJECTABLE;INJECTION | 021148-002 | Jun 20, 2000 | Start Trial | Start Trial |
| Novo Nordisk Inc | NORDITROPIN | somatropin | INJECTABLE;INJECTION | 021148-003 | Jun 20, 2000 | Start Trial | Start Trial |
| Novo Nordisk Inc | NORDITROPIN | somatropin | INJECTABLE;INJECTION | 021148-001 | Jun 20, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
