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SYMLIN Drug Profile
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When do Symlin patents expire, and what generic alternatives are available?
Symlin is a drug marketed by Astrazeneca Ab and is included in one NDA. There is one patent protecting this drug.
This drug has thirty-two patent family members in sixteen countries.
The generic ingredient in SYMLIN is pramlintide acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pramlintide acetate profile page.
US ANDA Litigation and Generic Entry Outlook for Symlin
Symlin was eligible for patent challenges on March 16th, 2009.
Summary for SYMLIN
| International Patents: | 32 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 7 |
| Clinical Trials: | 19 |
| Patent Applications: | 35 |
| Drug Prices: | Drug price information for SYMLIN |
| DailyMed Link: | SYMLIN at DailyMed |
Recent Clinical Trials for SYMLIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boston University | Early Phase 1 |
| Adocia | Phase 1 |
| Bristol-Myers Squibb | Phase 4 |
Pharmacology for SYMLIN
| Drug Class | Amylin Analog |
| Mechanism of Action | Amylin Agonists |
Synonyms for SYMLIN
| 25-L-proline-28-L-proline-29-L-proline-, acetate (salt), hydrate |
| 25-L-Proline-28-L-proline-29-L-prolineamylin (human) acetate (salt), hydrate |
| AC0137 |
| ACO137 |
| AN-7554 |
| LS-181996 |
| LS-188084 |
| Pramlintide [USAN] |
| Pramlintide acetate [USAN] |
| SCHEMBL238214 |
US Patents and Regulatory Information for SYMLIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | DISCN | No | No | Start Trial | Start Trial | Y | 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 SYMLIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | Start Trial | Start Trial |
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-003 | Sep 25, 2007 | Start Trial | Start Trial |
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | Start Trial | Start Trial |
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-002 | Sep 25, 2007 | Start Trial | Start Trial |
| Astrazeneca Ab | SYMLIN | pramlintide acetate | INJECTABLE;SUBCUTANEOUS | 021332-001 | Mar 16, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SYMLIN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovakia | 88793 | Start Trial |
| Japan | H06504794 | Start Trial |
| Japan | 2006213716 | Start Trial |
| Japan | 2902115 | Start Trial |
| European Patent Office | 0567626 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
